Job Description Job Title: Senior Manager – Medical Affairs
n Location: Hyderabad
n Department: Medical Affairs
n Reporting To: Head – Medical Affairs
n Job Summary
nSeeking 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 robust expertise in clinical research, medical writing, and regulatory compliance.
n Key Responsibilities
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- Develop and review clinical study protocols (Phase IV, IIS, observational studies)n
- Monitoring of the clinical trialsn
- Prepare and update Investigator’s Brochure (IB)n
- Lead scientific writing team : for manuscripts, abstracts, posters, publicationsn
- Manage end-to-end journal submission & publication process n
- Collaborate on statistical analysis plans (SAP) and interpret clinical datan
- Ensure compliance with International Council for Harmonisation – GCP and regulatory guidelinesn
- Engage with KOLs and support advisory boards/scientific meetingsn
- Review medical content for scientific accuracy and compliancen
- Support regulatory documentation and cross-functional teamsn
n Qualification
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- PhD / Post-Doctorate in Life Sciences / Pharmacy / Biotechnology / Clinical Researchn
- MD / PharmD – preferredn
n Experience
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- 8-10 years in Medical Affairs / Clinical Researchn
- Hands-on experience in:n
- Protocol developmentn
- IB preparationn
- Manuscript writing & publicationsn
- Statistical analysisn
n Key Skills
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- Strong scientific writing & publication expertise n
- Knowledge of clinical research & regulatory guidelines n
- Proficiency in SAS / R / SPSS n
- Excellent communication & stakeholder managementn
n KPIs
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- Publications (quality & timelines)n
- Protocol & IB delivery timelinesn
- Compliance and audit readinessn
- KOL engagement effectivenessn