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Medical Writer (Clinical Research)

2-8 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Medical Writer (Clinical Research)


Company:

Sun Pharma Laboratories Ltd


Location:

Sun House, Goregaon East, Mumbai, India


Job ID / Posting Date:

Posted on April 11, 2025


Role Summary:

The Medical Writer will be responsible for preparing high-quality clinical documents including protocols, investigator brochures, regulatory documents, clinical study reports (CSRs), publications, and related documents. This role will involve writing manuscripts, abstracts, posters for conferences, coordinating with vendors for outsourced activities, and assisting in the procurement of scales for clinical trials.


Key Responsibilities:

Systems and Processes:

  • Follow clinical and regulatory guidelines for medical science activities.

  • Ensure compliance with internal medical writing SOPs for clinical trials.

  • Write, review, and coordinate clinical protocols with the operations team for feasibility and quality.

  • Review study documents such as statistical analysis plans, data monitoring plans, and coding plans.

  • Lead process improvement initiatives and create metrics for performance evaluation.

Activities:

  • Prepare clinical trial documents (protocol, CSR, SOPs) in accordance 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.

  • Coordinate with vendors for manuscript writing and abstract/poster preparation.

  • Collaborate with data management for timely data extraction and cleaning activities.

  • Work with biostatisticians to review sample size certificates, statistical analysis plans, and TFLs (tables, figures, listings).

  • Register clinical trials on appropriate registries (e.g., CTRI).

  • Ensure medical writing deliverables comply with ICH and other relevant regulatory guidelines.

Team & Mentorship:

  • Mentor and lead less experienced medical writers on complex projects.


Qualifications:

  • Education: B. Pharma/M.Sc/M.Pharma/PhD/BAMS/BHMS/Life Sciences background.

  • Experience: 2-8 years of relevant medical writing experience.

  • Skills:

    • Strong medical writing skills and proficiency with IMRaD, CONSORT, and publication guidelines.

    • Knowledge of GCP, GDP, ICMR, Drugs and Cosmetic Act regulations, and FDA guidelines.

    • Experience working in matrix business environments preferred.

    • Proficiency in Excel and other statistical tools.


Key Competencies:

  • Strong communication and writing skills.

  • Ability to work collaboratively in a matrix environment.

  • Strong analytical and strategic thinking skills.

  • Sense of urgency and performance-driven mindset.

  • Self-awareness and adaptability.