Key Responsibilities:
- Prepare high-quality clinical protocols, investigator brochures, regulatory documents, data reviews, clinical study reports, publications, and related clinical documents.
- Write manuscripts, prepare posters/abstracts for conferences, and coordinate with vendors for outsourced activities.
- Assist in the procurement of clinical scales.
- Ensure compliance with clinical and regulatory guidelines and internal SOPs for clinical trials.
- Review protocols for new trials in collaboration with the operations team.
- Coordinate review processes for study synopsis from clinical, regulatory, and operational perspectives.
- Prepare and review SOPs specific to medical writing for clinical trials.
- Work closely with medical monitors on reviewing study documents and data review activities.
- Lead and recommend process improvement initiatives.
- Evaluate metrics to assess performance and implement plans for improvement.
- Use systems like MedDRA and WHO-DD for data coding, including coding of adverse events and drugs.
- Understand randomization procedures and blinding techniques used in clinical trials.
Activities:
- Prepare protocols, Clinical Study Reports (CSRs), and SOPs in line with ICH GCP and regulatory requirements.
- Conduct literature searches for protocol, CSR, and manuscript writing.
- Write clinical journal manuscripts, abstracts, and study articles for publication.
- Present protocols and clinical study reports at subject expert committee (SEC) regulatory meetings.
- Collaborate with vendors for manuscript writing, abstract/poster preparation, and procurement of clinical scales/PROs.
- Coordinate with data management teams for data review and database lock.
- Engage early with biostatisticians for sample size certification and review of statistical analysis plans.
- Register on clinical trials registries (e.g., CTRI).
- Ensure medical writing deliverables conform to ICH and other regulatory guidelines.
- Create and maintain SOPs and work instructions for medical writing deliverables.
- Mentor and lead less experienced medical writers on complex projects.
Requirements:
- Strong medical writing skills with a background in life sciences.
- Familiarity with guidelines such as IMRaD, CONSORT, GCP/GDP regulations, ICMR guidelines, and the Drugs and Cosmetic Act.
- Experience working in a matrix business environment is preferred.
- Demonstrated success through annual performance ratings or professional accomplishments and awards.
- Strong knowledge of clinical research and medical writing activities.
- Ability to collaborate in a matrix environment and think strategically.
- Excellent writing, communication, and interpersonal skills.
- Proficiency with Excel or statistical software tools.
- Self-awareness and adaptability to work in a dynamic environment.
- Result-oriented and performance-driven.
Physical Requirements/Working Conditions:
- The role is based at Sun House, Mumbai. Occasional travel may be required for official work.
Selection Process:
- The selection will be based on an interview.
- Mode of Interview: Face-to-Face
- Interview Rounds: HR
