Senior Manager / AGM Scientific Writing in Clinical Research

Vacancy for Senior Manager / AGM - Scientific Writing in Clinical Research Department.

Qualification:

• M.Pharm., Pharm.D., M.D. (Pharmacology), M.Sc. (Life Sciences), or equivalent.

Experience:

• 10 to 15 years of relevant experience in Scientific/Medical Writing within the pharmaceutical or CRO industry.
• Experience in preparing clinical and regulatory documents across different phases of drug development.

Key Responsibilities:

• Prepare, review, and finalize study protocols for Clinical Studies (Phase IIV), Bioequivalence (BE) studies, Post-Marketing Surveillance (PMS) studies, Preclinical studies, Biosimilar studies (PK/PD and comparative efficacy/safety), and Clinical Endpoint studies.
• Prepare and review Clinical Study Reports (CSRs), Bioequivalence Study Reports, and other scientific and regulatory documents in accordance with ICH, GCP, and applicable regulatory guidelines.
• Collaborate closely with statisticians to interpret statistical analysis results and accurately incorporate statistical findings into CSRs, manuscripts, and other scientific documents.
• Prepare scientific manuscripts, abstracts, posters, and presentations for publications, conferences, and internal scientific communication.
• Develop high-quality scientific presentations related to study protocols, study results, clinical development programs, and regulatory submissions.
• Provide scientific writing support for regulatory submissions and prepare responses to queries from regulatory authorities, Ethics Committees, and Institutional Review Boards.

Required Skills

• Strong scientific and medical writing skills with excellent command of written English.
• Thorough understanding of clinical research methodology, drug development, and regulatory documentation.
• Strong literature review, data interpretation, critical appraisal, and scientific communication skills.