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Medical Affairs Mgr Job (Lima, PE)

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Medical Affairs Mgr-MED000744

Description

The Medical Affairs Manager is part of the country Medical Affairs Department. This position has a significant impact on our ability to effectively translate medical science into relevant business opportunities with high standards of local regulatory and compliance requirements. The role requires the ability to interact with a sort of different stakeholders like key scientific leaders, marketing and sales peers, decision makers as well as regulatory authorities in order to effectively address technical issues for MSD products and therapeutic areas of interest

RESPONSIBILITIES:

Scientific Leadership:

- Responsible for scientific knowledge management, translating information into strategic advice on therapeutic areas of interest for MSD products / competitors;
- Interaction with Scientific Leaders (SL) providing support to business units;
- Organize and conduct local advisory boards and Expert Input Forum meetings and collect customer needs from SLs;
- Attend stand alone and satellite scientific events.
- Provides medical information requests/answers to questions from local customers.

Internal Support:

- Support to products team, providing scientific support to achieve marketing / strategic objectives;
- Support to inclusion of Merck products in hospital formularies and in local therapeutic guidelines;
- Participate in strategic defense of MSD products with key decisions makers;
- Advise to legal and regulatory departments on the inquiries concerning MSD products;
- Provide sales representatives technical training.

Medical Review

- Review of locally developed materials to ensure medical relevance and compliance with regulations;
- Limited review of regionally developed materials to ensure compliance with local legal regulations, and to local customized materials.
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DPOC

- Act as backup for the DPOC person in the subsidiary.

Regulatory

- Advises Regulatory Affairs on the medical and scientific aspects of MSD products;

Pharmacovigilance

- Provides support to activities that assure reporting of Pharmacovigilance cases;

Clinical Trials

- Provide suggestions for clinical research (investigators, objectives, design, sites, studies) upon request;
- Manage post-development portfolio of studies including IISPs and local studies of respective area;

Qualifications

Required:

- MD University degree from accredited university;
- ID – ICU - Internal Medicine specialty background and a solid knowledge of a variety of disease areas and therapies;
- Excellent communication and people skills;
- Results oriented;
- Fluent in English;

Desired

- Experience in Medical Affairs in a first tier pharmaceutical industry;
- Experience with international/local clinical research and Pharmacovigilance;

*LI-KT1

Job: Medical Affairs (M.D.) - Field Based

Job Title: Sr. Spclst, Medical Affairs

Primary Location: LATAM-Peru-Lima-Lima

Employee Status: Regular

Number of Openings: 1

Senior Specialist Compliance & Risk Management Job (EMEA-Netherlands)

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Senior Specialist Compliance & Risk Management-COM000183

Description

For our MMD IT Compliance department we are currently looking for a:

Senior Specialist Compliance & Risk Management

About MSD

MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies, consumer care and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD has a workforce of over 6.000 in the Netherlands at five different sites. For more information, visit our website www.msd.nl or www.msd-animal-health.nl/

Organization

The MMD IT Compliance department is a global, above-site team of subject matter experts (SMEs) on the field of IT Compliance and risk management within the MMD and Animal Health (AH) divisions. The main objectives of this team are:

- Identifying, communicating and mitigating risk in the area of regulatory (GxP, SOX, Data Privacy, etc) IT and automation compliance;

- enabling a continuous, cost-effective and business efficient IT compliance by application of Quality by Design (QbD), sigma and continuous improvement principles.

The position

The Senior Specialist IT Compliance & Risk Management is responsible for providing overall IT/ automation compliance and inspection leadership to the IT site teams across a number of our MMD and AH facilities in mainland Europe. In addition to the site based IT teams, this function will also support the global (above site) animal health IT teams, based in Boxmeer (The Netherlands). As part of this the Senior Specialist IT Compliance & Risk Management will be responsible for:

- Monitoring and managing IT compliance risks in the assigned sites and (sub)regions; .

- Acting as a credible change agent to assure consistency in direction, practice, focus and alignment of global, regional and site IT and related computer system validation compliance;
- Developing, training and/ or enforcing system development lifecycle (SDLC) standards and supporting tools ( job aids, best practices, etc) in alignment with corporate and divisional policies, guidelines all applicable legal and regulatory requirements (e.g. EU Eudralex Vol 4, Annex 11; 21 CFR Part 210/211/11, SOX 404, etc) and industry standards (e.g. Good Automation Manufacturing Practices (GAMP));

- Developing, training and/ or enforcing compliance with IT security and identifying/ accessing management requirements, policies, standards and tools, to ensure security and effective management of Merck information and technology;

- Providing hands-on CSV/ IT compliance guidance for strategic projects.

- Full management of IT compliance related projects, including budgets and (external) resources;

- Aligning with various IT, business and quality functions on IT Compliance practices, positions and issues;

- Periodically supporting IT assessment and auditing of MSD/Merck & Co. internal sites as well as suppliers.

- Accountable for the successful realisation of all IT and Automation related projects across the sub-region;

- Acting as the focal point for interactions and escalations back to all IT shared-service functions;

- Contributing to the development and driving the local execution of the global IT strategy;

- Managing IT demand, IT portfolio planning, forecasts and updates across the sub-region.

The role will report into the MMD-IT Director, Compliance & Risk Management for Continental Europe, Africa, AP/J & Animal Health.

The role can be either based in The Netherlands or Belgium and he/ she will be travelling up to 25% of the time within the Continental Europe area.

Qualifications

The candidate

- Minimum Bachelor's Degree - BS in Engineering, Chemistry, Computer Science, or other technical degree;
- At least 10 years of working experience in a Health Authority regulated environment (Pharmaceuticals, devices, etc);

- At least 5 years of working experience in a pharmaceutical IT compliance, Computer System Validation or related field;

- Strong knowledge of GxP laws, rules and regulations (Examples: Eudralex Volume 4, 21CFRPart 210/211/11) and related industry guidance on (e.g. GAMP 5 and related Good Practice Guides);

- Experience in both execution and coordination of validation projects for GxP applications;

- Strong knowledge and experience in the field of risk management (including FMEA);

- Ability to identify, analyse & articulate potential compliance challenges as well as ability to make recommendation on addressing those challenges;

- Result driven team player with the ability to work independently, set priorities and collaborate with peers and management to remediate identified risks and potential compliance issues;

- Strong communication and collaboration skills, being diplomatic and able to compromise;

- Analytical thinking, problem solving capabilities and strong attention to detail;

- Ongoing focus on identification and realization of improvement potential;

- Affinity for IT and automation systems;

- Excellent oral and written skills in English (Dutch and/ or other languages are a plus).

- Experience in working with regional, cross-cultural and cross-divisional teams (a plus);

- Experience in SOX and data privacy (a plus);

- Experience in Six Sigma or equivalent process optimisation principles (a plus).

A good place to work

MSD is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, mechatronic engineers, pharmacists and operators. MSD always seeks ‘best-in-class’ employees at all levels. We expect a lot from our people and MSD has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what MSD values and rewards most. If you enjoy being challenged, over and over again, MSD will be a good place for you to work. We have an excellent fringe benefit program, and we invest heavily in the development of our people. MSD gives you plenty of opportunities for individual initiative and responsibility.

Information
For further information regarding this position, you can contact Tim Goossens, MMD-IT Director, Compliance & Risk Management for Continental Europe, Africa, AP/J & Animal Health,

+32 496.86.42.32.

Application

If you are interested in this position, you are invited to apply online.

*LI-RS1

Job: Compliance & Risk Management

Job Title: Senior Specialist Compliance & Risk Management

Primary Location: EMEA-Netherlands

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Manager Global CMC Regulatory Affairs - Supply Job (EMEA-Netherlands)

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Manager Global CMC Regulatory Affairs - Supply-REG001119

Description

For our location in Oss (The Netherlands) we are currently recruiting a:

Manager Global CMC Regulatory Affairs - Supply

About MSD

MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies, consumer care and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD has a workforce of over 6.000 in the Netherlands at five different sites. For more information, visit our website www.msd.nl or www.msd-animal-health.nl/

The position

MSD has a challenging opening for a candidate who not only can demonstrate CMC regulatory expertise, but also management capability. The successful candidate will lead a team located in Oss (The Netherlands) that currently encompasses 8 staff members and 2 contractors responsible for the maintenance of existing chemical and pharmaceutical manufacturing and controls (CMC) worldwide registrations. This is done through:

·

* Supervising/ coordinating/ preparing/reviewing the chemistry, manufacturing, and controls information for worldwide marketing of pharmaceutical products (NDA, WMA, MAA) to include annual reports, registration renewals, supplements, variations and responses;

* · Defining the strategy for filing post approval changes, responding to agency or subsidiary questions;

* · Prioritizing workload for the team;

* · Resolving issues;

* · Corresponding continuously and interacting with regulatory agencies and other Merck scientists to support in-line product filings worldwide;

* · Maintaining a working knowledge of current governmental and worldwide requirements for re-registration and post-approval changes;

* · Assuring that that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems;

* · Ensuring consistency in practices, championing best practices and promoting operational excellence;

* · Partnering with others in the pharmaceutical industry and regulators to reduce the regulatory burden of making post approval improvements in CMC;

* · Identifying initiatives to promote Operational Excellence;

* · Supporting new and existing CMC systems (RCAM, ORION, QSIS) and assuring compliance with those systems;

* · Supporting staffing needs, training, promoting growth through new opportunities and understanding of each person's Employee Development Plan;

* · Identifying and promoting best practices within CMC;

* · Maintaining superior knowledge of current government regulations and worldwide requirements for initial registration, re-registration and post-approval changes;

* · Demonstrating leadership in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etcetera;

* · Participating in external discussion groups, societies, working groups to influence market requirements, promoting harmonization, and reducing the regulatory burden;

* · Identifying internal and external customer needs and leading the team in accordance with those needs.

Qualifications

The candidate

* · Degree in pharmacy, bio-pharmaceutics, analytical chemistry, organic chemistry, chemical engineering or a related discipline;

* · At least ten years of industrial experience in chemical/ pharmaceutical research or manufacturing including processing and/ or analytical testing;

* · Working knowledge in quality assurance and quality systems (a plus);

* · Significant knowledge of regulations related to CMC;

* · Able to manage projects to achieve high productivity, prioritizing, and managing effective meetings;

* · Effective leadership;

* · Providing strategic direction and facilitating changes needed to move in that direction;

* · Innovative, flexible and collaborative;

* · Demonstrated problem solving and decision making skills;

* · Positive vision for the future of Merck/ MSD;

* · Awareness of Merck’s/ MSD’s overall business objectives and strategies;

* · Working knowledge of Word, Excel, PowerPoint and Document Management Systems;

* · Superior oral and written communication skills in English, Dutch and/or other languages are preferred.

A good place to work

MSD is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, mechatronic engineers, pharmacists and operators. MSD always seeks ‘best-in-class’ employees at all levels. We expect a lot from our people and MSD has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what MSD values and rewards most. If you enjoy being challenged, over and over again, MSD will be a good place for you to work. We have an excellent fringe benefit program, and we invest heavily in the development of our people. MSD gives you plenty of opportunities for individual initiative and responsibility.

Information

For more information about the vacancy, please contact Tom Sam, Head Global CMC Regulatory Affairs, by phone: +31 6 101 837 60 or via e-mail tom.sam@merck.com.

Application

If you are interested in this position, you are invited to apply online.

Job: Regulatory Affairs - CMC

Job Title: Manager Global CMC Regulatory Affairs - Supply

Primary Location: EMEA-Netherlands

Employee Status: Regular

Number of Openings: 1

Therapy Manager - Chennai HIV Job (Chennai, IN)

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Therapy Manager - Chennai HIV-DIR005892

Description

Product Promotion:
- Drive opening of new business avenues for HIV in own territory hospitals through promotion of BU products to respective Medical fraternity in order to generate the business of the HIV product portfolio
- Use detail aids to support scientific selling and Liaison with the HOD's , Purchase committee and Drug Committee doctors at the institutions for inclusion of the Respiratory Products in the pharmacopoeia

Territory Sales:
- To prepare a target list of customers as per therapy profile. Understand and implement marketing strategies to medical fraternity to generate prescriptions for the cc products.
- To maintain and balance right distribution of products to the Pharmacy.

Market Intelligence/ Sales Reporting
-Interact with paramedical staff in hospitals to seek inputs on competitor activities, patients moving on MSD products, new products in the hospital etc. to maintain intelligence on MSD and competitor activity in the hospital
- Provide field reports in terms of FIRM, Tracker and Sales statement etc. in order to update the sales MIS

Demand Generation and Stock Liquidation:
- Develop relationships with heads of departments in the hospital and influence them to drive liquidation of MSD stock and seek recommendations for MSD products
- Coordinate with KAM and purchase officer to generate demand for MSD products
- Coordinate with stockists for order execution

Customer Relationship Management:
- Organizing and conducting CME's with the user department at the institution in coordination to create and build the market for MSD products
- Manage the relationship with KOL's. Build, maintain and grow new KBL's and support CRM-Scientific activities with KOL's

Qualifications

B Pharm / BSc

Job: Direct Sales -Nondurable Goods

Job Title: Customer Representative

Primary Location: APAC-IN-TN-Chennai

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): N/A

Key Account Manager Job (EMEA-Egypt)

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Key Account Manager-KEY000110

Description

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Merck is known as MSD outside the United States and Canada.



- Set priorities for Key accounts coverage for Delta region.

- Understand and map Decision Making Unit within the accounts, build strong relationship with the stakeholders, develop unique ways to grow the business and Explore opportunities.

- En-list the new products through influencing decision makers (consultants / technical committees), manage company expenditure to promote its product, capitalizing on the support of Sales, Marketing and Medical and other KAMs support at central accounts.

- Ensure products availability in all pharmacies within the covered accounts and the flow of stocks from the main store, keep track of stock levels, consumption rates, expiry dates and issue necessary reports.

- Co-ordinate with Tender Manager (Tender books, submissions, competitive information, attendance of tender negotiation sessions).

- Ensure timely orders implementation through distributors.

- Monitor competitors’ activities & observe sales trends, share with sales and marketing for appropriate action planning.

Coordinate with KAMs the execution of key activities in Delta branches of centrally covered accounts

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.



Merck is an equal opportunity employer, proudly embracing diversity in all of its manifestations.


The position closes May 19th.

Qualifications

· Pharmacy, Medicine, Veterinary, or Dentistry Graduate.

· Minimum 2 years’ experience working as CR or PS at least one year at MSD.” responsible for key accounts is preferable”

· Results oriented with ability to meet deadlines and handle challenging assignments.

· Very Good command of English language/ Computer skills.

· Competent presentation skills.

· Self-motivated and energetic with drive to excel.

Willingness to travel (at least 60% of time) within Delta region/ Egypt

Job: Key Account Management

Job Title: Key Account Manager

Primary Location: EMEA-Egypt

Employee Status: Regular

Number of Openings: 1

Manager Production Planning (high potential position) Job (Boxmeer, NL)

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Manager Production Planning (high potential position)-LOG000173

Description

MSD Animal Health develops and produces vaccines and pharmaceutical specialties for livestock, companion animals and fish. We have offices in more than 50 countries, sell our products in over 140 markets and operate in a network of manufacturing sites and research and development facilities around the world. Within Merck Animal Health, we are always seeking innovative talents that focus on constant improvement of our products and the way we work. We’re looking for new colleagues who are entrepreneurs and result driven. But not only results matter; how you achieve these results is crucial to be successful within Merck Animal Health as well. Merck Animal Health leads the way in veterinary pharmaceuticals. For more information please visit us at http://www.merck-animal-health.com/

The Boxmeer facility is part of the global MMD AH network and manufactures and packs animal health products. The IPT Bacterial & Viral Inactivated is responsible and accountable for all resources that are required to produce bacterial and inactivated viral vaccines according to GMP standards. The scope of this IPT contains: Bacteriological Production, Formulation, part of the Filling Department, Bioreactor Facility and the supporting activities Planning, Maintenance & Reliability and Improvement.

Currently this IPT is looking for a:
Manager Production Planning (high potential position)

The primary purpose of the position is to lead a small planning team in the IPT and to manage the timely availability of antigens and finished product unpacked (FPU) in order to service the IPT’s customers with prompt deliveries. The Planning Lead reports to the IPT Lead. We are looking for a young professional moving to a second or third step is his/her career and ambition to learn and develop in the highly complex changing world of pharmaceutical.

Your tasks will be:

- Supports IPT Lead in budget set up, performance targets and KPI’s in production planning. Analyzes actual performance, investigates variances and makes proposals to improve.
- Interacts with Global Merck Supply chain department, Global Marketing and the customer IPT on supply issues and with Merck production sites in the forecasting and ordering process.
- Responsible for production program, scheduling, release of work orders and for inventory targets and inventory levels for the products within the IPT.
- Developing and introduction of new innovative logistic concepts and methodologies.
- Leads the Tier process of the Planning group and participates in the Tier process of IPT.
- Manages the master data processes of parts, Bill of Materials and processing/setup times and facilitates the process improvements in master data.
- Plans and manages product transfers, is responsible for the annual revision of planning master data like campaign size, order quantities and lead times.
- Performs an annual supply chain risk assessment to set the safety stock levels at the decoupling points.

Qualifications

- MSc. in Industrial Engineering, Business Science, Logistics or equivalent qualifications in Supply Chain Management.
- 5 – 10 years of experience in complex, global Supply Chain Management environment (e.g. FMCG, Automotive, Pharma).
- Proven capability with developing and introducing of new logistic concepts and designs.
- Demonstrated knowledge of continuous improvement methodology (e.g. Six Sigma).
- Strong project management skills and change management skills.
- Excellent analytical and conceptual thinker.
- Good interpersonal and leadership skills to manage and guide team members and coach them to capable professionals with a mindset for continuous willingness to change.
- Excellent oral and written skills in English (Dutch is a strong advantage).
- Competencies: Analyzing skills/learning ability, communication skills, people-oriented leadership/coaching, task-oriented leadership, focus on results and self-reflection.

A good place to work

MSD Animal Health is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, pharmacists and operators. MSD Animal Health always seeks ‘best-in-class’ employees at all levels. We expect a lot from our people and MSD Animal Health has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what MSD Animal Health values and rewards most.

*LI-KR1

Job: Logistics

Job Title: Manager

Primary Location: EMEA-Netherlands-NB-Boxmeer

Employee Status: Regular

Travel: No

Number of Openings: 1

Shift (if applicable): N/A

Stagiaire Human Resources Job (Haarlem, NH, Nederland)

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Stagiaire Human Resources-HUM004735

Omschrijving
MSD is op zoek naar een enthousiaste en ambitieuze:

Stagiaire Human Resources

ten behoeve van de afdeling Human Resources.

Merck Sharp & Dohme Haarlem is een farmaceutisch bedrijf waar ongeveer 800 medewerkers werkzaam zijn. MSD produceert, verpakt en verzendt geneesmiddelen naar meer dan 140 landen. Met veel verschillende verpakkingen, en volgens de hoogste kwaliteitsnormen. Ons motto is:

"We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if

we have remembered that, they have never failed to appear."

Recentelijk is MSD gefuseerd met branchegenoot Schering-Plough. De afdeling Human Resources speelt een belangrijke rol in de verandering- en integratieprocessen die hiermee samenhangen.

MSD kenmerkt zich door een open cultuur met veel ruimte voor eigen initiatief. Jouw ontwikkeling staat in deze stage centraal, maar we willen ook graag van jou leren!

De werkzaamheden bestaan o.a. uit:

· Zelfstandig uitvoeren en beheren van het stagebeleid, waaronder het voeren van sollicitatiegesprekken en exitinterviews.

· In samenwerking met HR Business Partners uitvoering geven aan HR-processen, zoals: performancemanagement, ziekteverzuim en het Employee Development Plan.

· Meewerken aan verschillende projecten, bijvoorbeeld functiewaardering.

· Organiseren van en deelnemen aan MSD bedrijfspresentatie op bedrijvenbeurzen van Universiteiten en Hogescholen.

· Het bieden van ondersteuning aan het Human Resources Team en betrokken zijn bij afhandeling van administratieve- en secretariële werkzaamheden.

· Advies geven aan medewerkers betreffende vragen over de CAO, het Handboek Sociaal beleid en Wet Verbetering Poortwachter.

· Nieuwe medewerkers en groepen scholieren bekend maken met de organisatie middels het begeleiden van rondleidingen en/of het geven van presentaties.

De beschreven werkzaamheden vormen het basispakket en zullen na een goede inwerk- en leerperiode vaak zelfstandig uitgevoerd worden. Op eigen initiatief of door vraag vanuit de organisatie kunnen deze worden aangevuld met andere projecten en/of taken.

Kwalificaties
Wij zoeken:

Een derdejaars Hbo-student Human Resource Management of Personeel & Arbeid die:

· vanaf september 2013, 4 of 5 dagen per week gedurende een periode van 5 of 10 maanden beschikbaar is.

· Zelfstandig bovengenoemde werkzaamheden oppakt.

· Een professionele houding heeft en zich staande weet te houden binnen een grote dynamische organisatie.

Wij bieden:

· Een breed georiënteerde stageplaats, die je in staat stelt om met veel aspecten van het vakgebied kennis te maken en daar ervaring in op te doen, met veel ruimte voor eigen initiatief.

· Een uitdagende en dynamische leeromgeving met veel ruimte voor persoonlijke ontwikkeling.

· Goede begeleiding door een ervaren Human Resource Specialist.

· Een stagevergoeding van € 375,00 bruto per maand (op basis van een 40-urige werkweek)

Informatie & Sollicitatie:

Heb je belangstelling voor deze stageplaats stuur dan een email met je sollicitatiebrief en CV vóór

31 mei naar: noortje.kok@merck.com. Of stuur je brief naar:

Merck Sharp & Dohme BV

T.a.v. Noortje Kok

Postbus 581

2003 PC Haarlem

Voor meer informatie over de stage kun je contact opnemen via bovenstaand e-mailadres of telefonisch via: 023-5153939.

De sollicitatieprocedure bestaat uit 2 gesprekken.
Functie: Human Resources_
Job Title: Stagiaire Human Resources

Primaire locatie: EMEA-Nederland-NH-Haarlem
Status van medewerker: Tijdelijk
Aantal vacatures: 1

Pharmaceutical Specialist Job (Haarlem, NH, Nederland)

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Pharmaceutical Specialist-QUA003301

Omschrijving
Voor onze vestiging te Haarlem zijn wij voor de IPT’s (Integrated Process Team) Blister en Vaccines op zoek naar twee Pharmaceutical Specialists.

Doel van de functie:

Als Pharmaceutical Specialist ben je verantwoordelijk voor het initiëren en uitvoeren van kwaliteitsverbeteringen en voor het op peil houden van de quality en compliance status van de IPT. Je ondersteunt de dagelijkse operatie met raad en daad. Daarbij adviseer je over farmaceutisch technische issues, onderzoekt problemen en implementeert oplossingen. De Pharmaceutical Specialist rapporteert rechtstreeks aan de IPT leader.

Functie-inhoud:

· Adviseren van de IPT Leader en QR Coach over het effect op de kwaliteit van het product als gevolg van veranderingen en/of afwijkingen in het proces.

· Evalueren van de consequenties van externe guidelines, als ook het initiëren en ontwikkelen van farmaceutisch beleid en procedures. Het beoordelen van afwijkingen op procedures en beleidslijnen en het autoriseren van GMP documentatie.

· Adviseren ten aanzien van interne en externe GMP inspecties.

· Leiden van en/of het inhoudelijk bijdragen aan onderzoek in geval van non-standaard, complexe of hoge-impact kwaliteitsissues, gebaseerd op uw farmaceutische expertise en analyses.

· Uitvoeren van validatiestudies waaronder cleaning validatie.

· Formuleren van voorstellen/business cases voor kwaliteitsverbeteringprojecten inclusief deliverables en planning.

· Opstellen van annual product reviews zoals vereist in de EU wetgeving.

Kwalificaties
· Academisch werk- en denkniveau met een aantal jaren relevante ervaring.

· Kennis van en ervaring hebben met farmaceutisch technische aspecten, GMP processen en Packaging Technology

· Ervaring met (farmaceutische) verpakkingsprocessen is een pré.

· Zelfstandig, kritisch en nauwkeurig

· Communicatief sterk

· Stevige persoonlijkheid

Afdelingen

De IPT Blister is verantwoordelijk voor het totale proces van het plannen, technisch/farmaceutisch ondersteunen en verpakken van humane geneesmiddelen in doordrukstrip-verpakkingen. De strategische focus van het IPT Blister is gericht op het minimaliseren van de kosten, middels het optimaal inzetten van de MPS/Lean principes.

De IPT Vaccines is binnen MSD verantwoordelijk voor de totale keten van ontvangst van bulk Vaccines, het verpakken van de Vaccines tot en met de coldchain distributie. Vanaf het ontwikkelen en bestellen van componenten en bulk tot aan het afleveren in de verzendverpakking. De strategische focus van de IPT Vaccines is onder andere gericht op het minimaliseren van de kosten, met een wisselende vraag en bulk beschikbaarheid, tegen de gevraagde kwaliteit, middels het optimaal inzetten van de lean-principes.

Over MSD

Het MSD van vandaag is wereldleider op het gebied van gezondheidszorg en werkt mee aan een gezonde wereld. Met onze geneesmiddelen, vaccins, biologische therapieën, producten en diensten voor consumenten en dieren bieden we innovatieve behandelingen voor een betere gezondheid van patiënten en dieren in meer dan 140 landen. We zijn actief betrokken bij een betere toegang tot de gezondheidszorg. Dat doen we met uitgebreid beleid, programma’s en samenwerkingsverbanden. Bij MSD in Nederland werken meer dan 6000 medewerkers op 5 verschillende locaties. Voor meer informatie ga naar http://www.msd.nl/.

Acquisitie naar aanleiding van deze advertentie wordt niet op prijs gesteld

- LI-RG1
Functie: kwaliteitsverzekering en -operations generisch
Job Title: Pharmaceutical Specialist

Primaire locatie: EMEA-Nederland-NH-Haarlem
Status van medewerker: Vast
Aantal vacatures: 1

Project Manager - Pharmaceutical Technology and Support Job (Munich, DE)

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Project Manager - Pharmaceutical Technology and Support-PRO010390

Description

MSD Animal Health offers veterinarians, farmers, pet owners and governments the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services.

MSD Animal Health is committed to operating its business in a way that is best suited to meet the unprecedented demands faced today. Its strategic goal is to achieve sustained growth through the continued provision of integrated solutions with innovative animal health products and services that meet the evolving needs of our customers

We are looking for our production site in Unterschleissheim, Munich, a

Project Manager – Pharmaceutical Technology and Support (m/w)

Brief description of position:

* This position ensures that Pharma process technology projects are carried out with a consistent approach and on a timely basis in line with the Manufacturing Division of MSD Animal Health strategy, Global Animal Health Quality strategy as well as applicable regulatory requirements. The majority of these projects will be concentrated around Animal Health liquids and semi-liquids products.

* The position holder is a Subject Matter Expert in the area of the production of Solutions, suspensions, creams and ointments. He/she has knowledge of sterile manufacturing and the associated requirements.

* The position holder is responsible for and specialized in topics like product introduction and technology transfer, process improvement, process validation, analytical method transfer,?

* The position holder is able to act as a team leader and can be held responsible for the performance and/or start-up of a new and/or difficult process technology assignment.

* The manufacturing sites that are supported by the person in this position can include those within the Animal Health Pharma region including third parties producing Animal Health Pharma products (across Europe).

* The position holder will concentrate his/her activities primarily on the support of the Manufacturing Division of MSD Animal Health production plants which are producing Liquids and Semi-Liquids.

Qualifications

*
Master or PhD degree in Science (Process technology, Pharmaceutical technology, Industrial Chemistry, Food technology,?)

*
5-10 years of experience in technology or manufacturing position (GMP compliant environment).

*
Strong GMP and Regulatory knowledge (FDA and EMEA)

*
Ideally experience in the production or the development of Liquids and Semi-Liquids.

*
Ideally Tech Transfer experience (site to site or R&D to site)

*
Project management skills

*
English and German (fluent), other languages are an asset

*
Travel requirement: willing to travel to different MMD production locations (40% of time)

Are you interested in contributing your know-how to a dynamic and innovative environment that allows you to show initiative and that offers long-term perspectives?

Then we look forward to receiving your application.

Please visit us at: http://www.msd-tiergesundheit.de/

*LI-DR1

Job: Process Engineering

Job Title: Project Manager - Pharmaceutical Technology and Support, Munich (Unterschleissheim)

Primary Location: EMEA-Germany-BY-Munich

Employee Status: Regular

Travel: Yes, 50 % of the Time

Number of Openings: 1

Senior Sales Representative, Primary Care Job (Ballerup, 84, Denmark)

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Senior Sales Representative, Primary Care-SAL003370

Description

About MSD

Today’s MSD is working to help the world be well. Through our prescription medicines, vaccines, biological therapies, and consumer care and animal health products and services, we work in more than 140 countries to deliver innovative health solutions to patients and animals. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. For more information, visit our website. http://www.msd.dk/

About MSD in Denmark

We are a significant provider to the Danish health service and supply more than 90 different treatments for a wide range of therapeutic areas, and we are the global pharmaceutical company, that invests the most in clinical research in Denmark. We employ approximately 200 highly qualified employees that work within sales, marketing and clinical research and policy/medical affairs in 3 divisions: Global Human Health, Merck Research Laboratories and Animal Health. In a time where many international businesses move their activities to other Scandinavian locations, MSD has chosen to consolidate its Mid-European activities in Denmark. MSD offices in Ballerup, Copenhagen, are the base for MSD’s Mid-Europe 2 regional headquarters which count approximately 1,600 employees in 10 countries (Denmark, Iceland, Sweden, Norway, Finland, Switzerland, Austria, Latvia, Estonia and Lithuania). The region runs clinical studies involving approximately 30,000 patients and investments in research and development amount to nearly 90 million dollars US dollars annually.

Human Health Denmark

We make products that touch the lives of millions on a global scale. That’s the reason we come to work every day. Our human health portfolio includes healthcare solutions and innovative treatment in areas such as heart disease, diabetes, arthritis, allergies, HIV, Hepatitis C, ophthalmology, asthma, osteoporosis and gastroenterology. We have a long heritage in the development of vaccines and when it comes to solving healthcare problems of the future, our portfolio is supported by a robust pipeline, with a range of products in each phase of development. That is how we help bring about a healthier world – one in which we all do our part to make what’s possible, real.

Position Overview:

As a sales representative, you get an interesting and varied job with exciting challenges. You are responsible for planning, prioritizing, and implementing sales activities for our primary customers - the primary care physicians (general practitioners). In addition to planning and implementing individual meetings and group meetings in primary care physician offices, your responsibilities will be planning and implementing local meetings in districts and participation in symposia, conferences and congresses both in Denmark and abroad. You are part of a dynamic and innovative team, and you are responsible for achieving sales targets in the Copenhagen territory for assigned MSD promoted products with a current focus on products within the atherosclerosis and diabetes franchises.

As a sales representative you are required to work with the territory team and other MSD personnel to develop and implement district activity plans and meeting customer needs. You are also required to actively utilize new multichannel communication methods and activities. The sales representative works within the ethical standards of the company and the legal regulations in the country.

Roles & Responsibilities:

Responsible for own territory business (revenue and income).

Responsible for understanding and fulfilling own customer’s needs which are in line with business priorities and needs.

Responsible for planning and implementing optimal activities to achieve targets.

Responsible for arranging individual meetings, educational meetings and symposia in primary care physician offices, health centers, and other venues for physicians and other HCP’s.

To work effectively in co-operation with both office based MSD colleagues and colleagues working at the same territory.

Create additional value and solutions to customers and build trust.

Utilization of wide range of communication channels to serve customer needs.
Utilization of CRM system for effective planning and prioritization of selling activities based on own territory data analysis.

Qualifications

Educational background and Experience:

Health Care Professional and/or business degree.

Experience from the pharmaceutical industry and/or medical device industry.

Personal qualifications

Business oriented and has entrepreneurial mindset;

Ability and willingness to use CRM system effectively;

Prudent risk taking;

Strong analytic thinking skills which leads to especially in segmentation, targeting and tracking;

Excellent communication skills;

Teamwork oriented with leadership skills;

Solution and goal oriented;

Fluent in Danish & English;

Skills to establish trusted long term customer relationships and networks, understanding of customer needs and readiness to implement appropriate actions

Good computing skills and ability to learn new IT solutions;

Ability and willingness to use new multichannel communication solution resources effectively to meet customer needs;

New kind of thinking, able to find hiding business, ability to think how to use the available tools to provide individual physicians with more value;

Ability to prioritize and focus work according to business opportunities.

A good place to work

If you enjoy being challenged, over and over again, MSD will be a good place for you to work. We have an excellent fringe benefit program, and we invest heavily in the development of our people. MSD gives you plenty of opportunities for individual initiative and responsibility.

Our pharmaceuticals that have changed the world

Since MSD was founded in the late 18th century, the company has developed pharmaceuticals with a great impact on the global public health.

Penicillin: In the late 1930’s, MSD started doing research in antibiotics. The first penicillin treatment was available from MSD’s laboratories in the USA in 1942.

Vaccines: In earlier days, no preventive treatments were available against diseases such as measles, mumps, varicella (chickenpox) and rubella. MSD is behind several of the vaccines that are part of vaccination programs all over the world today.

HIV/AIDS: In 1996, MSD launched a protease-antagonist, Crixivan, for the treatment of HIV/AIDS. Today, this remains one of the most complex pharmaceuticals ever developed by chemical synthesis.

Statins: In 1987, MSD launched the World’s first statin, Meyacor. Today, statins is the most widely used group of pharmaceuticals to lower cholesterol.

Osteoporosis: In 1996, MSD launched Fosamax – a new treatment in a new class of pharmaceuticals against osteoporosis which prevents bone deterioration.

*LI-LVG1

Job: Sales

Job Title: Senior Sales Representative, Primary Care

Primary Location: EMEA-Denmark-84-Ballerup

Employee Status: Regular

Number of Openings: 1

Senior Sales Representative, Primary Care Job (Ballerup, DK)

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Senior Sales Representative, Primary Care-SAL003370

Description

About MSD

Today’s MSD is working to help the world be well. Through our prescription medicines, vaccines, biological therapies, and consumer care and animal health products and services, we work in more than 140 countries to deliver innovative health solutions to patients and animals. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. For more information, visit our website. http://www.msd.dk/

About MSD in Denmark

We are a significant provider to the Danish health service and supply more than 90 different treatments for a wide range of therapeutic areas, and we are the global pharmaceutical company, that invests the most in clinical research in Denmark. We employ approximately 200 highly qualified employees that work within sales, marketing and clinical research and policy/medical affairs in 3 divisions: Global Human Health, Merck Research Laboratories and Animal Health. In a time where many international businesses move their activities to other Scandinavian locations, MSD has chosen to consolidate its Mid-European activities in Denmark. MSD offices in Ballerup, Copenhagen, are the base for MSD’s Mid-Europe 2 regional headquarters which count approximately 1,600 employees in 10 countries (Denmark, Iceland, Sweden, Norway, Finland, Switzerland, Austria, Latvia, Estonia and Lithuania). The region runs clinical studies involving approximately 30,000 patients and investments in research and development amount to nearly 90 million dollars US dollars annually.

Human Health Denmark

We make products that touch the lives of millions on a global scale. That’s the reason we come to work every day. Our human health portfolio includes healthcare solutions and innovative treatment in areas such as heart disease, diabetes, arthritis, allergies, HIV, Hepatitis C, ophthalmology, asthma, osteoporosis and gastroenterology. We have a long heritage in the development of vaccines and when it comes to solving healthcare problems of the future, our portfolio is supported by a robust pipeline, with a range of products in each phase of development. That is how we help bring about a healthier world – one in which we all do our part to make what’s possible, real.

Position Overview:

As a sales representative, you get an interesting and varied job with exciting challenges. You are responsible for planning, prioritizing, and implementing sales activities for our primary customers - the primary care physicians (general practitioners). In addition to planning and implementing individual meetings and group meetings in primary care physician offices, your responsibilities will be planning and implementing local meetings in districts and participation in symposia, conferences and congresses both in Denmark and abroad. You are part of a dynamic and innovative team, and you are responsible for achieving sales targets in the Copenhagen territory for assigned MSD promoted products with a current focus on products within the atherosclerosis and diabetes franchises.

As a sales representative you are required to work with the territory team and other MSD personnel to develop and implement district activity plans and meeting customer needs. You are also required to actively utilize new multichannel communication methods and activities. The sales representative works within the ethical standards of the company and the legal regulations in the country.

Roles & Responsibilities:

Responsible for own territory business (revenue and income).

Responsible for understanding and fulfilling own customer’s needs which are in line with business priorities and needs.

Responsible for planning and implementing optimal activities to achieve targets.

Responsible for arranging individual meetings, educational meetings and symposia in primary care physician offices, health centers, and other venues for physicians and other HCP’s.

To work effectively in co-operation with both office based MSD colleagues and colleagues working at the same territory.

Create additional value and solutions to customers and build trust.

Utilization of wide range of communication channels to serve customer needs.
Utilization of CRM system for effective planning and prioritization of selling activities based on own territory data analysis.

Qualifications

Educational background and Experience:

Health Care Professional and/or business degree.

Experience from the pharmaceutical industry and/or medical device industry.

Personal qualifications

Business oriented and has entrepreneurial mindset;

Ability and willingness to use CRM system effectively;

Prudent risk taking;

Strong analytic thinking skills which leads to especially in segmentation, targeting and tracking;

Excellent communication skills;

Teamwork oriented with leadership skills;

Solution and goal oriented;

Fluent in Danish & English;

Skills to establish trusted long term customer relationships and networks, understanding of customer needs and readiness to implement appropriate actions

Good computing skills and ability to learn new IT solutions;

Ability and willingness to use new multichannel communication solution resources effectively to meet customer needs;

New kind of thinking, able to find hiding business, ability to think how to use the available tools to provide individual physicians with more value;

Ability to prioritize and focus work according to business opportunities.

A good place to work

If you enjoy being challenged, over and over again, MSD will be a good place for you to work. We have an excellent fringe benefit program, and we invest heavily in the development of our people. MSD gives you plenty of opportunities for individual initiative and responsibility.

Our pharmaceuticals that have changed the world

Since MSD was founded in the late 18th century, the company has developed pharmaceuticals with a great impact on the global public health.

Penicillin: In the late 1930’s, MSD started doing research in antibiotics. The first penicillin treatment was available from MSD’s laboratories in the USA in 1942.

Vaccines: In earlier days, no preventive treatments were available against diseases such as measles, mumps, varicella (chickenpox) and rubella. MSD is behind several of the vaccines that are part of vaccination programs all over the world today.

HIV/AIDS: In 1996, MSD launched a protease-antagonist, Crixivan, for the treatment of HIV/AIDS. Today, this remains one of the most complex pharmaceuticals ever developed by chemical synthesis.

Statins: In 1987, MSD launched the World’s first statin, Meyacor. Today, statins is the most widely used group of pharmaceuticals to lower cholesterol.

Osteoporosis: In 1996, MSD launched Fosamax – a new treatment in a new class of pharmaceuticals against osteoporosis which prevents bone deterioration.

*LI-LVG1

Job: Sales

Job Title: Senior Sales Representative, Primary Care

Primary Location: EMEA-Denmark-84-Ballerup

Employee Status: Regular

Number of Openings: 1

Manager R&D Operations & Lab Facilities Job (EMEA-Netherlands)

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Manager R&D Operations & Lab Facilities-RES001377

Description

MSD Animal Health develops and produces vaccines and pharmaceutical specialties for livestock, companion animals and fish. We have offices in more than 50 countries, sell our products in over 140 markets and operate in a network of manufacturing sites and research and development facilities around the world. Within Merck Animal Health, we are always seeking innovative talents that focus on constant improvement of our products and the way we work. We’re looking for new colleagues who are entrepreneurs and result driven. But not only results matter; how you achieve these results is crucial to be successful within Merck Animal Health as well. Merck Animal Health leads the way in veterinary pharmaceuticals. For more information please visit us at http://www.merck-animal-health.com

The Animal Health R&D organization for the development of biological products is now organized as a matrix organization with a primary focus on 5 species groups (Aquatic Animal Health, Companion Animals including Equine, Poultry, Ruminants Swine) and Discovery and Technology (D&T) which overarches all species. The species and D&T organizations determine the R&D program and portfolio globally and represent the hierarchical structure of the project oriented R&D organization. Non-scientific and administrative tasks in the Netherlands are organized through an Operations department which is designed to enhance an efficient R&D operation. The R&D Operations manager in the Netherlands will report to the Global Species Head Aquatic Animal Health. Due to this new structure, our site in Boxmeer is currently recruiting a

R&D Operations Manager & Lab Facilities

Main tasks:

* Has responsibility for the day to day running of the R&D laboratories in the Netherlands.

* Has direct oversight of service departments such as Service Laboratories, Library, and Secretarial support (in total 80 people).

* Manages the operation capability of R&D in the Netherlands

* Interacts with local site management to ensure proper flow of activities

* Provides (financial) tools in order to standardize and facilitate the timely completion for product transfers to manufacturing.

* Is responsible for the cascading of uniform and coherent communications within the R&D organization in the Netherlands.

* Is responsible for general HR related programs across the R&D departments (e.g. GLP and EHS training plans and time administration).

* Ensures compliance with EHS and availability of required operational permits and biological safety (this might also include IACUC responsibility).

* Budget responsibility for species overarching expenses and investments.

* Ensures IT-linkage and implementation of IT programs.

* Implements and organizes species overarching GLP requirements.

* Liaises with other divisions within the company (e.g. manufacturing, quality) on matters across species such as seed policies, GMP requirements, etc.

* Is responsible for the administrative aspects of third party contracts and outsourcing activities when these are applicable for multiple species.

* Is responsible for financial compliance for the R&D functions and the administration of the quarterly Capital expenditure system.

* Ensures general compliance with all Merck’s policies.

Qualifications

- Bachelor or Masters Degree (preferably in life sciences).

* At least ten years of working experience within an international pharmaceutical or research facility or other relevant management experience within a complex, international environment.

* Able to communicate, influence and negotiate at senior level.

* Proven ability in people management of large group of people (scope should be at least 20 people).

* Knowledge in the field of GLP and/or pharmaceutical production.

* Organizational talent.

* Conceptual thinking and focus on processes.

* Solid personality with no-nonsense mentality.

* Excellent oral and written skills in English and Dutch.

*LI-KR

A good place to work

MSD Animal Health is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, pharmacists and operators. MSD Animal Health always seeks ‘best in class’ employees at all levels. We expect a lot from our people and MSD Animal Health has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross border communication skills are what MSD Animal Health values and rewards most.

Information

For information about this vacancy please contact Koen Roozen at +31 (0)6 2141 9206 or koen.roozen@merck.com.

Job: Research Support Generic

Job Title: Dir, Research

Primary Location: EMEA-Netherlands

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): N/A

(Junior) Process Developer Bioprocess Technology & Support Freeze Drying Job (Boxmeer, NB, Nederland)

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(Junior) Process Developer Bioprocess Technology & Support Freeze Drying-PRO010701

Omschrijving
Bioprocess Technology & Support (BTS) zorgt voor ontwikkeling en opschaling van productieprocessen voor bacteriële en virale antigenen en vaccin bereiding (gevriesdroogd of in vloeibare formuleringen). Het BTS team is wereldwijd vertegenwoordigd en werkt nauw samen met Manufacturing, Quality en R&D van MSD Animal Health.

Op dit moment zoekt Bioprocess Technology & Support – Vaccine Manufacturing een (Junior) Process Developer Vaccine Manufacturing

Functieomschrijving:

-
Optimalisatie van bestaande vriesdroog cycli voor levende virale en bacteriele vaccins

-
Ontwikkeling van vriesdroog cycli voor nieuwe vaccins

-
Meten van kritische parameters van te vriesdrogen/gevriesdroogde producten

-
Data analyse en voorstellen maken voor nieuwe experimenten

-
Rapportage van resultaten in subject en progress memo’s

-
Ondersteunen van vriesdroog productie afdelingen bij (product) technische vraagstukken.

Kwalificaties
Functie-eisen:

-
Opleiding: HBO of BSc in chemische technologie, pharmacie of bioproces technologie en minimaal 2 jaar relevante werkervaring.

-
Aantoonbare affiniteit met techniek/technische apparatuur.

-
Goede communicatieve vaardigheden in het Nederlands en Engels zowel mondeling als geschreven.

-
Klant- en resultaatgericht.

-
Flexibele en praktische instelling.

-
Teamplayer.

-
Ervaring met het werken in een GLP omgeving is een pre.

MSD als werkgever

Keer op keer nieuwe uitdagingen aangaan, dat is wel iets wat je leuk moet vinden als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de diepte, door je te specialiseren in je vak. Maar ook door jezelf te verbreden en door te groeien naar een leidinggevende functie. Internationaal of juist heel lokaal, er zijn talloze andere mogelijkheden om stappen te zetten in je loopbaan, te rouleren in functies of te groeien in je functie. Werken bij MSD is werken in een dynamische high tech omgeving van internationale allure, die toch sterk lokaal geworteld is in Haarlem, Boxmeer en Oss.

- LI-KR
Functie: Procestechniek
Job Title: (Junior) Process Developer Bioprocess Technology & Support Freeze Drying

Primaire locatie: EMEA-Nederland-NB-Boxmeer
Status van medewerker: Vast
Aantal vacatures: 1

Senior Technical Specialist Upstream Processing Job (Oss, NL)

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Senior Technical Specialist Upstream Processing-CHE003887

Description

For our Biotech organization in Oss we are currently looking for a:

Senior Technical Specialist Upstream Processing

About MSD

MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies, consumer care and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD has a workforce of over 6.000 in the Netherlands at five different sites. For more information, visit our website www.msd.nl or www.msd-animal-health.nl/

The organization

The Technical Specialist Upstream Processing (USP) will be working at USP-Commercialization and Clinical Supply (CCS) team, which is part of the Technical Operations (Tech Ops) department. Tech Ops is responsible for the activities related to support clinical supply, the commercialization trajectory (process performance qualification, regulatory filing) up to regular commercial supply and the identification and implementation of continuous process improvements. Tech Ops activities are ‘data and knowledge driven’ and can either be based on hands-on experience within the large scale production plants, process data trending and analysis, as well as by executing laboratory studies. In addition to given support to manufacturing Tech Ops partners with other Centers of Excellence of Quality, regulatory and process development to meet the targets.

The position

The Technical Specialist will support the USP IPT (Integrated Production Team) as a technical process expert in order to continuous improve biotechnological manufacturing processes. He/ she has a clear focus on process performance and assists the IPT in order to meet compliance, delivery and improvement targets. As part of the role the Technical Specialist will be responsible for:

· Continuous process surveillance elements and executing trouble shooting activities, deviation assessments, global change control, trends/batch evaluations reporting and improvement projects;

· Supporting commercialization processes (i.e. process transfer, clinical supply manufacturing support including day-to-day troubleshooting and process qualification);

· Providing technical coverage for Large-Scale Cell Culture Operations within the USP IPT.

· Assessing improvement proposals by IPT on process impact;

· Reviewing Master Batch records, recipes and process related documentation from IPT;

· Adequately translating process requirements into GMP documents and successful executing processes;

· Writing cleaning verification/ validation protocol and Tech Ops technical reports;

· Training IPT staff on unit operation execution of new process;

· First line trouble shooting (partially) in collaboration with Process Development & Commercialization (PDC) and manucturing;

· Ensuring that documentation complies to GMP and EHS (environment, health & safety) regulations;

· Assisting IPT, CoE (Center of Excellence) Quality and Tech Ops for Pre-Approval Inspections, GMP inspections and audits as process expert;

· Collaborating internally with IPT Improvement Engineers, IPT Bioprocess Technicians, CoE’s Analytical Development Validation (ADV), Quality, PDC and Regulatory Affairs and externally with the Global Biotech Network for best practices.

Qualifications

The candidate

· MSc. in life sciences or equivalent (Biotechnology/ process technology or related);

· At least 10 years of relevant experience in biologics manufacturing and or biotechnological projects;

· Knowledge of product, raw materials and equipment specifications;

· Familiarity with Cell Culture operations and Monoclonal Antibody production (desired);

· Knowledge of affinity chromatography and virus inactivation unit operations (desired);

· Experience with TechTransfers and process qualifications (desired);

· Broad knowledge of GMP guidelines;

· Passion for Lean and CI;

· Flexible and ability to influence and communicate from shop floor to senior management;

· Willingness to certify or possessing green belt & design for six sigma (DFSS);

· Good command of writing and speaking in Dutch and English.

A good place to work

MSD is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, mechatronic engineers, pharmacists and operators. MSD always seeks ‘best-in-class’ employees at all levels. We expect a lot from our people and MSD has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what MSD values and rewards most. If you enjoy being challenged, over and over again, MSD will be a good place for you to work. We have an excellent fringe benefit program, and we invest heavily in the development of our people. MSD gives you plenty of opportunities for individual initiative and responsibility.

Information

For further information regarding this position, you can contact Lydia de Moes - Ooijkaas, Process Lead Techical Operations, +31 6 51998467 or via lydia.de.moes-ooijkaas@merck.com.

Application

If you are interested in this position, you are invited to apply online.

Acquisition by agencies is not appreciated.

*LI-RS1

Job: Chemical Engineering

Job Title: Senior Technical Specialist Upstream Processing

Primary Location: EMEA-Netherlands-NB-Oss

Employee Status: Regular

Number of Openings: 1

Pharmacovigilance Veterinarian Job (EMEA-Netherlands)

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Pharmacovigilance Veterinarian-DRU000207

Description

Pharmacovigilance is the collection, investigation and evaluation of complaints regarding the safety and efficacy of products marketed by MSD Animal Health. Reporting on these pharmacovigilance complaints is a statutory requirement of authorities worldwide.

The pharmacovigilance veterinarian will work in an international environment and maintain contact with all MSD Animal Health sites globally.

Main taksks:

* checking and evaluating pharmacovigilance reports from all MSD Animal Heath sites globally;

* initiating and coordinating investigations into pharmacovigilance reports;

* compiling statutory reports relating to pharmacovigilance;

* maintaining daily contact with veterinarians from the local MSD Animal Health companies and the relevant departments internationally;

* answering questions from authorities in the field of pharmacovigilance.

Qualifications

- completed university training in veterinary medicine with some practical experience;
- preferably experience in pharmacovigilance and/or registration of veterinary medicines;
- analytical capabilities;
- able to work with deadlines;
- experience with Microsoft Word and Excel;
- excellent communication skills, both written and spoken;
- good report-writing skills;
- an excellent command of English, both written and spoken.

Job: Drug/Dvcs Sfty Survnce (NonMD)

Job Title: Sr. Spclst, Drug Safety

Primary Location: EMEA-Netherlands

Employee Status: Regular

Number of Openings: 1

Customer Manager - Delta Job (Mansürah, AD DAQAHLIYAH)

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Customer Manager - Delta-DIR006004

Description

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Merck is known as MSD outside of the United States and Canada



·

· Ensure that sales targets for the lead product are achieved or exceeded by developing sales implementation plans in line with the approved marketing strategy and flawlessly executing these plans.

· Manage, Lead and inspire the sales team to ensure high individual and team performance.

· Ensure adequately staffed sales team with motivated and qualified employees by selecting, coaching, developing, rewarding and retaining the right people.

· Monitor execution of rep territory plans by reviewing key performance indicators

· Maintain proper collaboration with other sales teams in the district to ensure that implementation of all field operations are properly conducted for customers’ benefits.

· Manage regional key opinion leaders for the lead product.

· Monitor the customer base in the district. Know the customer.

· Monitor competitor activities in the district. Know the competition.

· Organize effective and professional meetings with targeted customers

· Ensure that communication between reps and the MSD organization is efficient, timely and accurate.

· Ensure that business is conducted according to Merck Policies & Procedures, and Standards and Values.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.



Merck is an equal opportunity employer, proudly embracing diversity in all of its manifestations.


The position will close on the 15th April 2013

Qualifications

Minimum 3 years sales experience ( Senior or executive customer representative, product specialist, etc) prioirties will be given to people management experience

Track record of consistent above plan performance for the past 3 years

Demonstrated MSD leadership behaviours (Customer focus, Ethics & Integrity, Collaboration, Rapid & disciplined decision making, Condor & courage)

Outstanding understanding & implementation of our customer facing strategies (Segmentation / Targeting, Buying ladder and customer centric interaction)

Job: Direct Sales Generic – Less Exp Rep

Job Title: Customer Manager - Delta

Primary Location: EMEA-Egypt-Ad Daqahliyah-Al-Mansürah

Employee Status: Regular

Number of Openings: 1

Manager R&D Operations & Lab Facilities Job (EMEA-Netherlands)

$
0
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Manager R&D Operations & Lab Facilities-RES001377

Description

MSD Animal Health develops and produces vaccines and pharmaceutical specialties for livestock, companion animals and fish. We have offices in more than 50 countries, sell our products in over 140 markets and operate in a network of manufacturing sites and research and development facilities around the world. Within Merck Animal Health, we are always seeking innovative talents that focus on constant improvement of our products and the way we work. We’re looking for new colleagues who are entrepreneurs and result driven. But not only results matter; how you achieve these results is crucial to be successful within Merck Animal Health as well. Merck Animal Health leads the way in veterinary pharmaceuticals. For more information please visit us at http://www.merck-animal-health.com

The Animal Health R&D organization for the development of biological products is now organized as a matrix organization with a primary focus on 5 species groups (Aquatic Animal Health, Companion Animals including Equine, Poultry, Ruminants Swine) and Discovery and Technology (D&T) which overarches all species. The species and D&T organizations determine the R&D program and portfolio globally and represent the hierarchical structure of the project oriented R&D organization. Non-scientific and administrative tasks in the Netherlands are organized through an Operations department which is designed to enhance an efficient R&D operation. The R&D Operations manager in the Netherlands will report to the Global Species Head Aquatic Animal Health. Due to this new structure, our site in Boxmeer is currently recruiting a

R&D Operations Manager & Lab Facilities

Main tasks:

* Has responsibility for the day to day running of the R&D laboratories in the Netherlands.

* Has direct oversight of service departments such as Service Laboratories, Library, and Secretarial support (in total 80 people).

* Manages the operation capability of R&D in the Netherlands

* Interacts with local site management to ensure proper flow of activities

* Provides (financial) tools in order to standardize and facilitate the timely completion for product transfers to manufacturing.

* Is responsible for the cascading of uniform and coherent communications within the R&D organization in the Netherlands.

* Is responsible for general HR related programs across the R&D departments (e.g. GLP and EHS training plans and time administration).

* Ensures compliance with EHS and availability of required operational permits and biological safety (this might also include IACUC responsibility).

* Budget responsibility for species overarching expenses and investments.

* Ensures IT-linkage and implementation of IT programs.

* Implements and organizes species overarching GLP requirements.

* Liaises with other divisions within the company (e.g. manufacturing, quality) on matters across species such as seed policies, GMP requirements, etc.

* Is responsible for the administrative aspects of third party contracts and outsourcing activities when these are applicable for multiple species.

* Is responsible for financial compliance for the R&D functions and the administration of the quarterly Capital expenditure system.

* Ensures general compliance with all Merck’s policies.

Qualifications

- Bachelor or Masters Degree (preferably in life sciences).

* At least ten years of working experience within an international pharmaceutical or research facility or other relevant management experience within a complex, international environment.

* Able to communicate, influence and negotiate at senior level.

* Proven ability in people management of large group of people (scope should be at least 20 people).

* Knowledge in the field of GLP and/or pharmaceutical production.

* Organizational talent.

* Conceptual thinking and focus on processes.

* Solid personality with no-nonsense mentality.

* Excellent oral and written skills in English and Dutch.

A good place to work

MSD Animal Health is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, pharmacists and operators. MSD Animal Health always seeks ‘best in class’ employees at all levels. We expect a lot from our people and MSD Animal Health has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross border communication skills are what MSD Animal Health values and rewards most.

Information

For information about this vacancy please contact Koen Roozen at +31 (0)6 2141 9206 or koen.roozen@merck.com.

*LI-KR

Job: Research Support Generic

Job Title: Dir, Research

Primary Location: EMEA-Netherlands

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): N/A

Manager - Medical Affairs (Chennai) Job (Bangalore, IN)

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Manager - Medical Affairs (Chennai)-MED000755

Description

Primary scientific face of MSD for SLs/OLs

• Spearhead implementation of research activities: directed towards enhancing research capabilities, generation of clinical/epidemiological evidences, Merck Investigator Studies Program (MISP) etc

• Spearhead implementation of educational activities: directed towards dissemination of evidence based clinical guidelines and best practices, establishing local academic networks, enhancing translation of guidelines in to practice and improving overall treatment patterns

Primary scientific resource for the sales team

• Training on therapy area, disease and products at induction and on ongoing basis

• Responding to all relevant scientific clinical queries raised by HCPs

• Speaker briefing and conduct of scientific meetings planned by sales & marketing team

• Scientific, non-promotional resource for implementation of other marketing campaigns of marketed products

• Reporting of adverse events related to MSD products

• Compliance advisor for sales and marketing activities and for promotional practices

Conflict of interest management

• To ensure scientific sanctity of all promotional and non-promotional activities being conducted by or on behalf of MSD

• To carefully avoid any inadvertent linkage of educational or research activities with commercial returns

Self development

• To update self on scientific developments in the respective therapy areas, not only to ensure professional development but also to ensure proper execution of responsibilities mentioned above

• To work on special project(s) of the department, including those related pipeline products, allocated primarily with the objective of job enrichment and career growth

• To acquire skills and strengths required to realize carrier development plans

Qualifications

• Medical Graduate having a MCI recognized degree

• Candidates with post graduate degree/diploma would be given preference

Job: Medical Affairs Generic

Job Title: Specialist

Primary Location: APAC-IN-KA-Bangalore

Employee Status: Regular

Travel: Yes, 75 % of the Time

Number of Openings: 1

Stagiaire Human Resources Job (Haarlem, NH, Nederland)

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Stagiaire Human Resources-HUM004735

Omschrijving
MSD is op zoek naar een enthousiaste en ambitieuze:

Stagiaire Human Resources

ten behoeve van de afdeling Human Resources.

Merck Sharp & Dohme Haarlem is een farmaceutisch bedrijf waar ongeveer 800 medewerkers werkzaam zijn. MSD produceert, verpakt en verzendt geneesmiddelen naar meer dan 140 landen. Met veel verschillende verpakkingen, en volgens de hoogste kwaliteitsnormen. Ons motto is:

"We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if

we have remembered that, they have never failed to appear."

Recentelijk is MSD gefuseerd met branchegenoot Schering-Plough. De afdeling Human Resources speelt een belangrijke rol in de verandering- en integratieprocessen die hiermee samenhangen.

MSD kenmerkt zich door een open cultuur met veel ruimte voor eigen initiatief. Jouw ontwikkeling staat in deze stage centraal, maar we willen ook graag van jou leren!

De werkzaamheden bestaan o.a. uit:

· Zelfstandig uitvoeren en beheren van het stagebeleid, waaronder het voeren van sollicitatiegesprekken en exitinterviews.

· In samenwerking met HR Business Partners uitvoering geven aan HR-processen, zoals: performancemanagement, ziekteverzuim en het Employee Development Plan.

· Meewerken aan verschillende projecten, bijvoorbeeld functiewaardering.

· Organiseren van en deelnemen aan MSD bedrijfspresentatie op bedrijvenbeurzen van Universiteiten en Hogescholen.

· Het bieden van ondersteuning aan het Human Resources Team en betrokken zijn bij afhandeling van administratieve- en secretariële werkzaamheden.

· Advies geven aan medewerkers betreffende vragen over de CAO, het Handboek Sociaal beleid en Wet Verbetering Poortwachter.

· Nieuwe medewerkers en groepen scholieren bekend maken met de organisatie middels het begeleiden van rondleidingen en/of het geven van presentaties.

De beschreven werkzaamheden vormen het basispakket en zullen na een goede inwerk- en leerperiode vaak zelfstandig uitgevoerd worden. Op eigen initiatief of door vraag vanuit de organisatie kunnen deze worden aangevuld met andere projecten en/of taken.

Kwalificaties
Wij zoeken:

Een derdejaars Hbo-student Human Resource Management of Personeel & Arbeid die:

· vanaf september 2013, 4 of 5 dagen per week gedurende een periode van 5 of 10 maanden beschikbaar is.

· Zelfstandig bovengenoemde werkzaamheden oppakt.

· Een professionele houding heeft en zich staande weet te houden binnen een grote dynamische organisatie.

Wij bieden:

· Een breed georiënteerde stageplaats, die je in staat stelt om met veel aspecten van het vakgebied kennis te maken en daar ervaring in op te doen, met veel ruimte voor eigen initiatief.

· Een uitdagende en dynamische leeromgeving met veel ruimte voor persoonlijke ontwikkeling.

· Goede begeleiding door een ervaren Human Resource Specialist.

· Een stagevergoeding van € 375,00 bruto per maand (op basis van een 40-urige werkweek)

Informatie & Sollicitatie:

Heb je belangstelling voor deze stageplaats stuur dan een email met je sollicitatiebrief en CV vóór

31 mei naar: noortje.kok@merck.com. Of stuur je brief naar:

Merck Sharp & Dohme BV

T.a.v. Noortje Kok

Postbus 581

2003 PC Haarlem

Voor meer informatie over de stage kun je contact opnemen via bovenstaand e-mailadres of telefonisch via: 023-5153939.

De sollicitatieprocedure bestaat uit 2 gesprekken.
Functie: Human Resources_
Job Title: Stagiaire Human Resources

Primaire locatie: EMEA-Nederland-NH-Haarlem
Status van medewerker: Tijdelijk
Aantal vacatures: 1

Pharmaceutical Specialist Job (Haarlem, NH, Nederland)

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Pharmaceutical Specialist-QUA003328

Omschrijving
Voor onze vestiging te Haarlem zijn wij voor de IPT (Integrated Process Team) Vaccines op zoek naar een Pharmaceutical Specialist.

Doel van de functie:

Als Pharmaceutical Specialist ben je verantwoordelijk voor het initiëren en uitvoeren van kwaliteitsverbeteringen en voor het op peil houden van de quality en compliance status van de IPT. Je ondersteunt de dagelijkse operatie met raad en daad. Daarbij adviseer je over farmaceutisch technische issues, onderzoekt problemen en implementeert oplossingen. De Pharmaceutical Specialist rapporteert rechtstreeks aan de IPT leader.

Functie-inhoud:

· Adviseren van de IPT Leader en QR Coach over het effect op de kwaliteit van het product als gevolg van veranderingen en/of afwijkingen in het proces.

· Evalueren van de consequenties van externe guidelines, als ook het initiëren en ontwikkelen van farmaceutisch beleid en procedures. Het beoordelen van afwijkingen op procedures en beleidslijnen en het autoriseren van GMP documentatie.

· Adviseren ten aanzien van interne en externe GMP inspecties.

· Leiden van en/of het inhoudelijk bijdragen aan onderzoek in geval van non-standaard, complexe of hoge-impact kwaliteitsissues, gebaseerd op uw farmaceutische expertise en analyses.

· Uitvoeren van validatiestudies waaronder cleaning validatie.

· Formuleren van voorstellen/business cases voor kwaliteitsverbeteringprojecten inclusief deliverables en planning.

· Opstellen van annual product reviews zoals vereist in de EU wetgeving.

Kwalificaties
· Academisch werk- en denkniveau met een aantal jaren relevante ervaring.

· Kennis van en ervaring hebben met farmaceutisch technische aspecten, GMP processen en Packaging Technology

· Ervaring met (farmaceutische) verpakkingsprocessen is een pré.

· Zelfstandig, kritisch en nauwkeurig

· Communicatief sterk

· Stevige persoonlijkheid

Afdeling

De IPT Vaccines is binnen MSD verantwoordelijk voor de totale keten van ontvangst van bulk Vaccines, het verpakken van de Vaccines tot en met de coldchain distributie. Vanaf het ontwikkelen en bestellen van componenten en bulk tot aan het afleveren in de verzendverpakking. De strategische focus van de IPT Vaccines is onder andere gericht op het minimaliseren van de kosten, met een wisselende vraag en bulk beschikbaarheid, tegen de gevraagde kwaliteit, middels het optimaal inzetten van de lean-principes.

Over MSD

Het MSD van vandaag is wereldleider op het gebied van gezondheidszorg en werkt mee aan een gezonde wereld. Met onze geneesmiddelen, vaccins, biologische therapieën, producten en diensten voor consumenten en dieren bieden we innovatieve behandelingen voor een betere gezondheid van patiënten en dieren in meer dan 140 landen. We zijn actief betrokken bij een betere toegang tot de gezondheidszorg. Dat doen we met uitgebreid beleid, programma’s en samenwerkingsverbanden. Bij MSD in Nederland werken meer dan 6000 medewerkers op 5 verschillende locaties. Voor meer informatie ga naar http://www.msd.nl/.

Acquisitie naar aanleiding van deze advertentie wordt niet op prijs gesteld

- LI-RG1
Functie: kwaliteitsverzekering en -operations generisch
Job Title: Pharmaceutisch Specialist

Primaire locatie: EMEA-Nederland-NH-Haarlem
Status van medewerker: Vast
Aantal vacatures: 1
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