Senior Manager

Ixoreal Biomed; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Ixoreal Biomed seeks a Senior Manager – Medical Affairs to lead clinical and scientific activities, including protocol development, IB preparation, manuscript writing and data analysis. The role requires expertise in clinical research, medical writing and regulatory compliance.

The candidate should have 8–10 years in Medical Affairs/Clinical Research, MD/PharmD preferred, and be proficient in SAS, R or SPSS. Collaboration across cross-functional teams is essential.

Qualifications

• PhD or post-doctoral qualification in life sciences or related field.
• MD/PharmD preferred for medical practice background.
• 8–10 years in Medical Affairs or clinical research roles.
• Experience in IB, protocol development, manuscripts and data analysis.
• Strong writing, regulatory awareness and scientific communication.

Responsibilities

• Develop and review clinical study protocols (Phase IV, IIS, observational studies).
• Monitor clinical trials and ensure GCP/regulatory compliance.
• Prepare and update Investigator’s Brochure (IB).
• Lead scientific writing for manuscripts, abstracts, posters and publications.
• Oversee end-to-end journal submission and publication processes.
• Collaborate on SAP and interpret clinical data.
• Engage with KOLs and support advisory boards and scientific meetings.
• Review medical content for accuracy and regulatory alignment.

Skills

Clinical research

Medical writing

Regulatory compliance

Statistical analysis

SAS

R

SPSS

KOL engagement

Team leadership

Publications

Data interpretation

Cross-functional collaboration

Education

PhD / Post-Doctorate in Life Sciences / Pharmacy / Biotechnology / Clinical Research

MD / PharmD – preferred

Tools

SAS

R

SPSS

Job description

Job Title: Senior Manager – Medical Affairs

Department: Medical Affairs

Reporting To: Head – Medical Affairs

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.

• 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
• PhD / Post-Doctorate in Life Sciences / Pharmacy / Biotechnology / Clinical Research
• MD / PharmD – preferred
• 8-10 years in Medical Affairs / Clinical Research
• Hands-on experience in:
• IB preparation
• Manuscript writing & publications
• Statistical analysis
• Strong scientific writing & publication expertise
• Knowledge of clinical research & regulatory guidelines
• Proficiency in SAS / R / SPSS
• Publications (quality & timelines)
• Protocol & IB delivery timelines
• Compliance and audit readiness

Other Requirements

• Ability to work in cross-functional teams
• Excellent Communications Skills Verbal & Written