Job Title: Senior Manager – Medical AffairsLocation:
HyderabadDepartment:
Medical AffairsReporting To:
Head – Medical AffairsJob SummarySeeking 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 ResponsibilitiesDevelop and review
clinical study protocols
(Phase IV, IIS, observational studies)Monitoring of the clinical trialsPrepare and update
Investigator’s Brochure (IB)Lead
scientific writing team : for manuscripts, abstracts, posters, publicationsManage
end-to-end journal submission & publication processCollaborate on
statistical analysis plans (SAP)
and interpret clinical dataEnsure compliance with
International Council for Harmonisation – GCP
and regulatory guidelinesEngage with
KOLs
and support advisory boards/scientific meetingsReview medical content for scientific accuracy and complianceSupport regulatory documentation and cross-functional teamsQualificationPhD / Post-Doctorate in Life Sciences / Pharmacy / Biotechnology / Clinical ResearchMD / PharmD – preferredExperience8-10 years in Medical Affairs / Clinical ResearchHands-on experience in:Protocol developmentIB preparationManuscript writing & publicationsStatistical analysisKey SkillsStrong
scientific writing & publication expertiseKnowledge of
clinical research & regulatory guidelinesProficiency in
SAS / R / SPSSExcellent communication & stakeholder managementKPIsPublications (quality & timelines)Protocol & IB delivery timelinesCompliance and audit readinessKOL engagement effectiveness
Other RequirementsStrong project management skillsAbility to work in cross-functional teamsExcellent Communications Skills Verbal & Written