Job Title: Senior Manager – Medical Affairs
Location: Hyderabad
Department: Medical Affairs
Reporting To: Head – Medical Affairs
Job Summary
Seeking a highly qualified PhD/Post-Doc skilled to lead clinical and scientific activities including protocol development, Investigator’s Brochure (IB), scientific publications, and data analysis. The role requires strong expertise in clinical research, medical writing, and regulatory compliance.
Key Responsibilities
Develop and review clinical study protocols (Phase IV, IIS, observational studies)
Monitoring of the clinical trials
Prepare and update Investigator’s Brochure (IB)
Lead scientific writing team : for manuscripts, abstracts, posters, publications
Manage end-to-end journal submission & publication process
Collaborate on statistical analysis plans (SAP) and interpret clinical data
Ensure compliance with International Council for Harmonisation – GCP and regulatory guidelines
Engage with KOLs and support advisory boards/scientific meetings
Review medical content for scientific accuracy and compliance
Support regulatory documentation and cross-functional teams
Qualification
PhD / Post-Doctorate in Life Sciences / Pharmacy / Biotechnology / Clinical Research
MD / PharmD – preferred
Experience
8-10 years in Medical Affairs / Clinical Research
Hands-on experience in:
Protocol development
IB preparation
Manuscript writing & publications
Statistical analysis
Key Skills
Strong scientific writing & publication expertise
Knowledge of clinical research & regulatory guidelines
Proficiency in SAS / R / SPSS
Excellent communication & stakeholder management
KPIs
Publications (quality & timelines)
Protocol & IB delivery timelines
Compliance and audit readiness
KOL engagement effectiveness
Other Requirements
Strong project management skills
Ability to work in cross-functional teams
Excellent Communications Skills Verbal & Written