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 professional to lead clinical and scientific activities including protocol development, Investigator's Brochure (IB), scientific publications, and data analysis. The role requires solid 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

📌 Senior Manager (Hyderabad)
🏢 Ixoreal Biomed
📍 Hyderabad