Location: 3rd Floor, PBN Center, Road No:45, Jubliee Hills, Hyderabad. Department: 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)
- Prepare and update Investigator’s Brochure (IB)
- Manage end to end Clinical Trails in all the aspects with schedule, Quality and
Compliance.
- Lead scientific writing: 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
- Attend the International Conferences during the trade shows and explain the queries required to the clients and the scientific community.
- Engage with KOLs and support advisory boards/scientific meetings
- Review medical content for scientific accuracy and compliance
- Support regulatory documentation and cross-functional teams.
- 12-15 years in Medical Affairs / Clinical Research
- Hands-on experience in:
o Protocol development o IB preparation o Manuscript writing & publications o Statistical analysis & methods o GCP & Clinical Trail Management.
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