Medical Writer (Clinical Research)
Location: Sun House - Corporate Office, Goregaon East, Mumbai
Company: Sun Pharma Laboratories Ltd
Date: April 11, 2025
Job Summary:
This role will be responsible for the preparation of high-quality clinical documents, including protocols, investigator brochures, regulatory documents, data reviews, clinical study reports (CSRs), publications, and related clinical materials. The position will also involve manuscript writing, poster/abstract preparation for conferences, coordinating with vendors for outsourced activities, and assisting with the procurement of clinical scales.
Your Tasks and Responsibilities:
Systems and Processes:
Ensure compliance with clinical and regulatory guidelines, processes, and systems for medical science activities, following internal medical writing SOPs for clinical trials.
Write, review, and revise protocols for new clinical trials, ensuring operational feasibility and high quality.
Coordinate the review process of study synopses from clinical, regulatory, and operational perspectives.
Prepare and review SOPs specific to medical writing for clinical trials.
Collaborate with medical monitors to review study documents such as statistical analysis plans, data monitoring plans, coding plans, and CRFs, and to support data review activities.
Identify, recommend, and lead process improvement initiatives.
Create and evaluate metrics to assess performance and implement corrective action plans.
Well-versed with MedDRA and WHO-DD for data coding, including coding adverse events and drugs.
Knowledgeable about randomization procedures and blinding techniques used in clinical trials.
Activities:
Responsible for clinical trial-related activities, including the preparation of protocols, CSRs, appendices, and SOPs, in line with ICH GCP, Indian, and global regulatory requirements.
Conduct literature searches for protocol, CSR, and manuscript writing.
Write clinical journal manuscripts, abstracts, and study articles for publication.
Prepare protocol and CSR presentations for regulatory meetings such as SEC (Subject Expert Committee).
Coordinate with vendors for manuscript writing, abstract/poster preparation, and the procurement of clinical scales/PROs (Patient-Reported Outcomes).
Work with the data management team to ensure timely data review and cleaning activities, ensuring timely database lock and release of TLFs (tables, listings, and figures).
Collaborate with biostatisticians on sample size certification, SAP review, and mock/blinded tables, figures, and listings review.
Coordinate with medical monitors for narrative and discussion planning for clinical trial documents.
Ensure registration on clinical trials registries (e.g., CTRI).
Ensure that all medical writing deliverables conform to ICH and relevant regulatory guidelines.
Create and maintain SOPs and work instructions for compliant medical writing deliverables.
Mentor and lead less experienced medical writers on complex projects as necessary.
Who You Are:
Educational Qualifications: B. Pharma/M.Sc/M.Pharma/PhD/BAMS/BHMS/Life Sciences.
Experience: 2-8 years of relevant medical writing experience.
Skills:
Excellent medical writing skills.
Well-versed in guidelines like IMRaD, CONSORT, and other relevant publication guidelines.
Familiar with current GCP/GDP regulations, GCP guidelines, ICMR guidelines (2017), and the Drugs and Cosmetic Act regulations for clinical trials.
Experience in matrix business environments is preferred.
Strong medical knowledge across different therapeutic areas.
Solid functional knowledge of clinical research and medical writing activities.
Strong collaboration and teamwork skills, with the ability to work in a matrix environment.
Strategic thinker with sound analytical skills.
Strong communication and writing skills.
Proficiency with Excel or statistical software tools.
Self-awareness and adaptability in a matrix environment.
Result-oriented with excellent interpersonal and communication skills.
Job Location: Sun House, Goregaon East, Mumbai
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Queensland |Melbourne :
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Greece |North Island :
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Japan | Saitama |Tokyo :
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