Job Description
Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is comprehended. We unite, communicate and train internal employees to ensure a thorough comprehension of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio
Under the general supervision of the Medical Director, the Medical Affairs Manager (MAM) manages the medical activities for one or more therapeutic area(s). MAM is a partner with marketing and market access regarding all relevant activities related to the therapeutic y area(s). In compliance with all applicable country regulation and our policies and procedures, the MAM is responsible for:
Contributing to short and long-term business objectives by optimizing medical and clinical excellence throughout the product lifecycle within the therapeutic areaProviding medical and scientific advice and input for business strategies, market access and others as required, as well as input into health economicsDeveloping Medical Affairs strategy via Medical Affairs Plan (MAP) for incumbent's therapy area(s) in the country and takes appropriate action to ensure proper implementation and appropriate management of budget related to these activities.Establishing, managing and owning high level of scientific and clinical interactions with customers: Scientific leaders, speakers, investigators, scientific societies or the likeA major part of the MAM role is maintaining high level of scientific interaction with customers, hence at least 50% of the job should be spend on customer interactions in the form of emails, telephone calls, face-to-face meetings whether pre-scheduled (congresses, symposia)or un-scheduled.Being recognized by customers and colleagues as the company's' expert in therapeutic areaHigh level scientific and medical/clinical interactions with regulatory and reimbursement authorities.The incumbent is expected to have appropriate knowledge and qualification, possess a good understanding of the relevant therapeutic areas, a strong working knowledge of all applicable local regulations and our global policies, procedures and processes. Ability to work effectively in a matrix organization and collaborate with colleagues on international level are highly desirable qualities.
Primary responsibilities include, but are not limited to:
Primary activities include, but are not limited to:
Strategic Activities
Planning and implementation of local Medical Affairs activities within the therapy area(s). Enhancing company reputation and profile by representing the company in relevant external and internal cross-functional, regional task forces or boards (e.g. internally: CE Cluster Team, Regional Medical Affairs Team (RMAT)) where relevant and feasible.
Developing Medical Affairs Plan (MAP) including relevant strategies related to:
Brand imperatives, key medical activities, outline specifics for the country (e.g. different standard of care, reimbursement timeline different than others, etc.). Prioritize and define development areas to meet all scientific- and medical needs and clinical care gaps. Identify scientific leaders and topics for discussion needed, as well as developing tactics including, but not limited to:
Management and execution of the GMA portfolio of medical programs and local studies within agreed timelines and budgetsThe planning, initiation and implementation of Local Clinical Evaluations (market experience programs/patient programs or other study types initiated locally) including preparation/review of protocols as needed in alignment with product franchise strategy, securing Sr. Management Approval. Execution of such programs lies with local clinical operations or externally via CRO (Clinical Research Organizations). MAM must secure final clinical study report / manuscript and ensure the publication of LCE.Secure input to HQ-sponsored study allocation as well as national company site selection and investigators. Maintain and update information for local study feasibility on continuous basis and provide timely reply to HQ Request for Information for local study feasibilityImplementing publication policy for the therapy areas, e.g. securing production of review articles or the likeActively search for meetings, symposia, congresses, Continuous Medical Education (CME), research grants/fellowships which could bring additional value to the relevant therapy areaExternal Scientific and Medical Interaction
Securing we keep our role of scientific leader by developing and managing a frequent and sustained dialogue with scientific leaders, investigators, and speakers.Plan and execute national and regional Advisory Boards.Contribute to our sponsored meetings and CME events, including engaging Scientific Leaders as speakers, development of slide kits and giving own lecture as relevant active participation in symposia and congresses.Contribute to formulary and clinical guideline development.Provide medical and scientific training and support/advise to internal customers, provide tailored responses to customers’ requests for Medical InformationInternal Scientific and Medical/Clinical Interaction
Providing medical and scientific training, internal medical expertise, support/advise within the therapeutic area to colleagues regardless of business unit and business function.Provide input to Market Access for access plans and programs including pricing, reimbursement and public affairs.Providing support to Regulatory department (support in translation checking (SmPC/PIL), DDLs, Safety information/training materials)Providing support to pharmacovigilance (compliance with reporting requirements)Ensure clinical and scientific accuracy of promotional materials through effective execution of the worldwide review process.Skills
Preferred proficient understanding of the drug development process, relevant diseases and therapies, and the local medical practiceDemonstrating strongly ethics and integrityExcellent interpersonal skills related to management of scientific leaders and authorities Collaborative problem solving approach within the team Excellent presentation skillsStrong leadership behaviours within delivering value for customers including patients by understanding and meeting their needs; act with candor and courage; make rapid, disciplined decisionsStrong stewardship skillsAbility to work effectively in a matrix organizationExcellent understanding of core systems, tools, and metricsEnglish on proficiency levelEducation & Experience
The position requires either a Medical Degree (preferred) or a PhD/PharmaD in life science.Relevant prior experience can replace the above mentioned degree requirements.Knowledge in the area of Vaccines is a big plus, being the initial therapeutic area relevant to the incumbent. Cardiology and Immunology are also a plus due to the potential future evolution of the role.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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability, Adaptability, Budget Management, Business Planning, Business Strategies, Clinical Research, Data Analysis, Drug Development, Healthcare Education, Immunochemistry, Life Science, Market Access, Medical Affairs, Medical Communications, Medical Knowledge, Medical Review, Medical Teaching, Medical Writing, Pharmaceutical Medical Affairs, Pharmacovigilance, Professional Integrity, Project Management, Promotional Review, Scientific Leadership, Scientific Literature {+ 1 more}Preferred Skills:
Job Posting End Date:
06/23/2025*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:R351916