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 qualified 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