Role and Responsibilities:
- Prepare and review protocols, investigator brochures, regulatory documents, clinical study reports, publications, and related clinical documents.
- Manuscript writing, poster/abstract preparation for conferences.
- Coordinate with vendors for outsourced activities.
- Assist in procurement of scales.
- Ensure compliance with clinical and regulatory guidelines, processes, and systems.
- Follow SOPs for clinical trial medical writing.
- Work with the operations team to ensure high-quality, operationally feasible clinical trial protocols.
- Review study synopses from clinical, regulatory, and operational perspectives.
- Collaborate with medical monitors to review study documents (e.g., statistical analysis plan, data monitoring plan, coding plan, CRF) and data review activities.
- Lead process improvement initiatives.
- Create and evaluate metrics to assess performance and implement plans for course correction.
- Familiarity with systems (MedDRA and WHO-DD) for data coding, including coding of adverse events and drugs.
- Knowledge of different randomization procedures and blinding techniques for clinical trials.
- Responsible for medical science-related activities like protocol preparation, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirements, Indian and global regulatory requirements.
- Conduct relevant literature searches for protocols, CSR, and manuscript writing.
- Prepare clinical journal manuscripts, abstracts, and study articles for publication.
- Prepare protocols and clinical study report presentations for regulatory meetings.
- Collaborate with vendors for manuscript writing, abstract/poster preparation, and procurement of clinical scales/PROs (Patient Reported Outcomes).
- Coordinate with the data management team for timely review of data extract and cleaning activities, ensuring timely database lock and release of tables, figures, and listings (TLFs).
- Engage with biostatisticians early in the study process for sample size certificates, review of statistical analysis plans (SAP), and review of mock and/or blinded TFLs, narratives, and discussion planning for relevant documents in coordination with the medical monitor.
- Register clinical trials on registries (e.g., CTRI).
- Ensure medical writing deliverables conform to ICH and other relevant regulatory guidelines.
- Create and maintain standard operating procedures and work instructions for compliant medical writing deliverables.
- Mentor and lead less experienced medical writers on complex projects, as necessary.
Candidate Profile:
- Educational background in B. Pharma/M.Sc/M.Pharma/PhD/BAMS/BHMS/life sciences.
- Relevant medical writing experience is desirable.
- Excellent medical writing skills.
- Familiarity with guidelines such as IMRAD, CONSORT, and other publication guidelines.
- Thorough knowledge of current GCP/GDP regulations, ICMR guidelines 2017, and Drugs and Cosmetic Act regulations related to clinical trials.
- Experience in matrix business environments is preferred.
- Strong medical knowledge of various therapeutic areas.
- Sound functional knowledge of clinical research and medical writing activities.
- Ability to work collaboratively in a matrix environment.
- Strategic thinking and analytical skills.
- Proficiency with Excel or statistical software tools.
- Strong interpersonal and communication skills.
- Result-oriented and performance-driven.
- Adaptability to work in a matrix environment.
Additional Information:
- Qualification: B. Pharma / M.Sc / M.Pharma / PhD / BAMS / BHMS / life sciences
- Application End Date: 25th July 2024
- Location: Mumbai, India
- Company: Sun Pharmaceutical Industries Limited
- Industry: Pharma/Healthcare/Clinical Research
