Position Purpose The Senior Specialist, Medical Affairs is a strategic scientific partner and an integral member of the cross-functional medical team, responsible for the development and execution of the medical strategy for assigned products and therapy areas within General Specialty Medicine. Operating as an individual contributor, the role ensures alignment of the Medical Affairs Plan, drives evidence generation, supports clinical-practice transformation, and provides medical and scientific leadership to internal and external stakeholders. The role additionally brings medical and scientific expertise into New Product Planning (NPP).

Key Responsibilities

- Scientific Medical Expertise
- Maintain deep clinical and scientific expertise in the assigned therapy area, products and the evolving scientific landscape.
- Serve as the subject-matter expert and trusted scientific counterpart for internal and external stakeholders.
- Provide expert medical / scientific advice, respond to medical queries, and develop medical information and clinical expert reviews.

- Medical Strategy Cross-Functional Leadership

- Lead and contribute to the Therapy-Area / Field Medical Strategic Plan, ensuring alignment with broader Medical Affairs objectives.
- Partner cross-functionally with Clinical Development, Regulatory, Pharmacovigilance and Market Access to develop and execute integrated medical plans, in line with compliance and medical-governance standards.
- Provide therapeutic rationale and scientific support for regulatory submissions, SEC (Subject Expert Committee) presentations and medical launch-readiness.

- Evidence Generation Clinical Research





- Provide medical and scientific expertise into the design of Phase 3b / Phase IV studies, RWE, registries, HEOR, epidemiological surveys and Investigator-Initiated Studies (IIS).
- Develop insight-driven medical plans; identify knowledge, practice and data gaps and recommend evidence-generation initiatives.

- KOL / External Stakeholder Engagement

- Identify and map Key Opinion Leaders (KOLs); build credible peer-to-peer scientific relationships.
- Conduct scientific engagement with KOLs through advisory boards, scientific workshops, congresses and medical-education programs; gather and translate scientific insights into medical strategy.

- Medical Education Scientific Communication

- Deliver high-quality scientific presentations and medical-education programs to healthcare professionals and internal teams.
- Support non-promotional scientific meetings as speaker / facilitator, conduct speaker briefings, and deliver scientific and disease-area training to internal cross-functional colleagues.

- Medical Review Compliance

- Serve as medical reviewer / signatory for promotional and non-promotional materials, ensuring scientific accuracy, fair balance and full compliance with internal SOPs and applicable regulations.

- Team Support Resource Management





- Support capability-building and scientific mentoring within the medical team; support planning and management of the medical-affairs budget for the assigned portfolio.

- Current Product Planning (NPP) Pre-Launch Readiness

- Serve as the medical and scientific expert within cross-functional New Product Planning teams, bringing early clinical, scientific and patient insights into pipeline and evidence-planning decisions.
- Contribute to indication sequencing and lifecycle medical strategy, ensuring scientific evidence and unmet-need insights guide program development.
- Provide medical input to proof-of-concept and pivotal trial design (endpoints, comparators, patient journey and evidence-generation strategy).
- Support pre-launch and launch-readiness activities - Medical Value Narratives, scientific training materials, CME / scientific decks and KOL advisory boards to advance understanding of the disease area.
- Partner cross-functionally with NPP, Regulatory, GCTO and Market Access to ensure early medical and scientific alignment on evidence and unmet-need requirements.

Qualifications Experience
- Education MBBS with MD (Pharmacology / Internal Medicine) preferred.

- Experience Typically 5-6+ years in pharmaceutical Medical Affairs, Clinical Research or Scientific Affairs (individual-contributor).

- Therapy-Area Exposure Relevant experience across General Specialty Medicine; cardiometabolic, pulmonology, immunology or specialty-care exposure advantageous.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Medical Advisor (Mumbai)
🏢 Merck Sharp u0026 Dohme (MSD)
📍 Mumbai