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
- Solid
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

📌 Senior Manager (Hyderabad)
🏢 Ixoreal Biomed
📍 Hyderabad