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

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