Job Description

The Medical Affairs Director is the Senior Medical Leader for our Company in the SEE cluster (Serbia, Croatia, Bulgaria, Slovenia, Bosnia, Albania, Nth Macedonia, Montenegro and Kosovo). (S)he reports directly to the Executive Medical Director for Baltics, CEE and SEE. S(he) leads a Team of Team Leaders, namely Associate Directors who are leading the Medical Advisors in the cluster countries. (S)he is responsible for:

Being the Medical representative in the SEE Leadership team

Being the Medical Representative in the Country Leadership Teams in Bulgaria Serbia and Slovenia/Croatia (with option to delegate this role to a country ADMA where appropriate whilst maintaining oversight and accountability)

Oversight of the development and execution of the Medical Affairs (MA) strategy for the country or cluster, based on understanding of global, regional and local opportunities and requirements

creating and maintaining a high performing, highly compliant MA organization for the country or cluster

representing local opportunities, requirements and needs at the regional and/or global levels, as appropriate

Medical Representative in the SEE Medical Governance Council

representing our Research & Development Division in the Country or Cluster Leadership Team

Representing our Company in external activities requiring the presence of the country’s (or cluster’s) Senior Medical Leader; and coordinating with the country or cluster GCTO, Pharmacovigilance, and (where applicable) CORE, BARDs, or DPED staff to ensure well-functioning interactions between our Company and external in-country stakeholders

Managing the entire portfolio for our company, allocating resources balancing global and local priorities. (S)he builds on existing capabilities through internal development and external hiring, analyzes and fills gaps by reallocating resources and creates an empowering, compliant, collaborative, and innovation-focused work environment

Managing the medical aspects of submissions for reimbursement or tenders for our Company’s entire portfolio of medicines and vaccines (collaboration with CORE, market access, and commercial colleagues).

As part of the Leadership of our Research & Development Division GMSA, the Country Medical Director (Director) will assist in maintaining our Research & Development Division GMSA as a leading research-based MA organization. As such (s)he will help create and execute a strategy for the future evolution of GMSA building on existing strengths while identifying key areas for improvement and implementing plans to address these elements.

Key Responsibilities

The Medical Director is responsible for oversight of all aspects of Cluster and local Medical Affairs (MA) in the SEE countries, including:

Country MA team focus on local our Research & Development Division MA strategy, with a heavy emphasis on helping to develop global MA strategy, support of strategic planning for medical support of Company objectives

Strategic planning and support of structured and consistent Continuous Medical Education (CME) activities

Strategic planning and support of Company interactions with Authorities and relevant Organizations at all levels

Building of close relationships with regulatory, GCTO departments.

Consulting Business Units on medical and scientific matters

Providing input into local study feasibility and sites selection and implementing publication policy

Providing medical and scientific advice to business units, market access functions and others as required, as well as input into Health Economics. Also serving as a member of the local leadership team

Managing the country developed Protocol Concept Sheets (PCS) and obtaining regional and global) approvals for new local studies

Review and approval of local study protocols and IISPs

Advising business units on medical and scientific matters, including—but not limited to—scientific approval of promotional materials

Ensuring compliance with all applicable country regulations; developing relationships with regulatory authorities in collaboration with the local head of regulatory

Overseeing all activities of local Medical Department employees

Overseeing inspections and answering inquiries by health authorities and ethical committees, in conjunction with Regulatory, PV and GCTO

Enhancing the company reputation and profile through an external focus, by representing the company on cross-company boards and industry associations, represents the Company in mass-media (in collaboration with PR Manager)

Orchestrate regional input for medical priority setting and co-sponsor the regional medical affairs planning teams to have bi-directional communication with HQ

May serve as subject matter expert for one therapeutic area for the country or cluster.

Qualifications, Skills & Experience

Required:

M.D. or equivalent degree from a recognized medical school. Additional advanced degrees, entry on a Specialist Register (Pharmaceutical Medicine or a relevant clinical specialty) and a current ‘license to practice’ are a strong plus

Minimum 5 years of experience in global biopharmaceutical industry in Clinical Development and/or Medical Affairs

Minimum of 3 years of people management experience running a large organization of healthcare professionals

Demonstrated effective organizational skills, including ability to set goals and align priorities

Experience in one of the following fields: Oncology, Infectious Diseases Treatment, Vaccines, or Specialty care. Experience in Oncology is a strong plus.

Preferred:

As noted above, an advanced degree (MPH, Ph.D., MBA, Degree in Health Administration or Economics)

As noted above, experience in Oncology (in a hospital, in a biopharmaceutical company, or an academic institution) is preferred

Strong understanding of the compliance environment in which Medical Affairs functions

Business acumen, ethics and credible reputation with the external scientific community

Successful leadership and expertise in management of a Medical Affairs team.

Experience in the development or field management of interventional/non interventional clinical studies

Ability to simplify and convey complex concepts and strategies, orally and in writing. Effectively conducts/facilitates meetings. Strong presentation skills

Demonstrated creativity and effectiveness in addressing strategic challenges

Possesses an entrepreneurial mindset; capable of thinking out of the box and taking measured risks

Experience working in global and regional medical affairs functions

Able to understand issues across a global affiliate network and contribute relevant insights as appropriate

Comfortable managing a matrix organization.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Advisory Board Development, Biopharmaceutical Industry, Clinical Development, Clinical Medicine, Decision Making, Expense Reimbursement, Healthcare Education, Health Economics, Hospital Medicine, Infectious Disease, Management Process, Medical Affairs, Medical Marketing Strategy, Medical Teaching, Multiple Therapeutic Areas, Oncology, People Leadership, Pharmaceutical Medical Affairs, Pharmacokinetics, Pharmacotherapy, Project Life Cycle Management, Reimbursement, Results-Oriented {+ 5 more}

 Preferred Skills:

Job Posting End Date:

08/12/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R358479