Senior Manager

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 strong 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