Medical Writer (Clinical Research)
Position: Medical Writer
Location: Sun House - Corporate Office, Goregaon East, Mumbai
Company: Sun Pharma Laboratories Ltd
Job Summary:
The Medical Writer (Clinical Research) will be responsible for preparing high-quality clinical documents, including protocols, investigator brochures, regulatory documents, clinical study reports, publications, and related materials. The role will involve manuscript writing, preparing posters and abstracts for conferences, coordinating with vendors for outsourced activities, and assisting with the procurement of clinical scales.
Responsibilities:
Systems and Processes:
Ensure compliance with clinical and regulatory guidelines for medical science activities and internal medical writing SOPs for clinical trials.
Write and review protocols for new trials, working closely with the operations team to ensure feasibility and quality.
Coordinate the review of study synopsis from clinical, regulatory, and operational perspectives.
Prepare and review SOPs specific to medical writing for clinical trials.
Collaborate with medical monitors for reviewing study documents (e.g., statistical analysis plan, data monitoring plan, coding plan, CRF) and data review activities.
Identify, recommend, and lead process improvement initiatives.
Evaluate performance metrics and implement course correction plans.
Be well-versed with systems (MedDRA and WHO-DD) for data coding, including coding adverse events and drugs.
Demonstrate knowledge of randomization procedures and blinding techniques used in clinical trials.
Activities:
Prepare clinical trial documents, including protocols, Clinical Study Reports (CSR), and appendices, ensuring compliance 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.
Prepare protocol and clinical study report presentations for expert committees (SEC) and 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 to ensure timely data review, data cleaning, and database lock.
Work with biostatisticians to review statistical analysis plans (SAP), sample size certificates, and mock/blinded tables, figures, and listings (TFLs).
Register trials on clinical trials registries (e.g., CTRI).
Ensure compliance with ICH and other relevant regulatory guidelines for medical writing deliverables.
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 background: B. Pharma/M.Sc/M.Pharma/PhD/BAMS/BHMS/life sciences.
2-8 years of relevant medical writing experience.
Excellent medical writing skills.
Familiar with publication guidelines (IMRAD, CONSORT, etc.) and current GCP/GDP regulations.
Strong knowledge of GCP, ICMR guidelines 2017, and the Drugs and Cosmetics Act.
Experience in matrix business environments preferred.
Proven success through performance ratings and professional accomplishments.
Strong medical knowledge across different therapeutic areas.
Sound functional knowledge of clinical research and medical writing activities.
Ability to collaborate and work in a matrix environment.
Strategic thinking and analytical skills.
Proficiency in Excel or statistical software tools.
Strong communication skills and ability to interact with a broad audience.
Job Location:
Sun House, Goregaon East, Mumbai
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Berlin |Germany :
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China | Quarry Bay |Hubei :
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