Job DescriptionJob Title: Senior Manager – Medical Affairs
nLocation: Hyderabad
nDepartment: Medical Affairs
nReporting To: Head – Medical Affairs
nJob Summary
nSeeking 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.
nKey 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 processn
- 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

nQualification
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- PhD / Post-Doctorate in Life Sciences / Pharmacy / Biotechnology / Clinical Researchn
- MD / PharmD – preferredn

nExperience
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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

nKey Skills
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- Strong scientific writing & publication expertisen
- Knowledge of clinical research & regulatory guidelinesn
- Proficiency in SAS / R / SPSSn
- Excellent communication & stakeholder managementn

nKPIs
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- Publications (quality & timelines)n
- Protocol & IB delivery timelinesn
- Compliance and audit readinessn
- KOL engagement effectivenessn

nOther Requirements
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- Strong project management skill

📌 Senior Manager (Hyderabad)
🏢 Ixoreal Biomed
📍 Hyderabad