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    Medical Writer

    Sun Pharma
    0-2 years
    Not Disclosed
    Mumbai
    10 Oct. 23, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Position: Medical Writer
    Location: Sun House, Mumbai

    Role and Responsibilities:
    This role involves the preparation of high-quality clinical documents, including protocols, investigator brochures, regulatory documents, data reviews, clinical study reports, publications, and related materials. Responsibilities include:

    • Manuscript writing and preparation of posters/abstracts for conferences.
    • Coordinating with vendors for outsourced activities and assisting in the procurement of scales.

    Systems and Processes:

    • Ensure compliance with clinical and regulatory guidelines, following internal medical writing SOPs for clinical trials.
    • Collaborate with the operations team to create operationally feasible protocols for new trials.
    • Coordinate the review of study synopses from clinical, regulatory, and operational perspectives.
    • Prepare and review SOPs specific to medical writing for clinical trials.
    • Work closely with medical monitors for the review of study documents, including statistical analysis plans and data monitoring plans.
    • Identify and lead process improvement initiatives, creating metrics to assess performance and implementing corrective plans.
    • Utilize systems like MedDRA and WHO-DD for data coding, including adverse events and drug coding.
    • Understand various randomization procedures and blinding techniques used in clinical trials.

    Activities:

    • Prepare clinical trial-related documents in line with ICH GCP requirements and relevant regulatory guidelines.
    • Conduct literature searches necessary for protocol, CSR, and manuscript writing.
    • Write clinical journal manuscripts, abstracts, and articles for publication.
    • Prepare protocol and CSR presentations for regulatory meetings.
    • Collaborate with vendors for manuscript writing and procurement of clinical scales/PROs.
    • Coordinate with data management and biostatistics teams to ensure timely review of data and statistical analyses.
    • Register studies on clinical trials registries (e.g., CTRI).
    • Maintain compliance with ICH guidelines and create SOPs for medical writing deliverables.
    • Mentor less experienced medical writers on complex projects as necessary.

    Related Experience Requirement:

    • Educational background in B.Pharm, M.Sc, M.Pharma, PhD, BAMS, BHMS, or life sciences. Relevant medical writing experience is desirable.
    • Excellent medical writing skills and familiarity with guidelines such as IMRaD and CONSORT.
    • Knowledge of current GCP/GDP regulations and familiarity with ICMR guidelines and the Drugs and Cosmetics Act.
    • Experience in matrix business environments is preferred.
    • Strong track record of success in prior roles.

    Competency Requirement:

    • Strong medical knowledge across different therapeutic areas.
    • Sound functional knowledge of clinical research and medical writing.
    • Ability to collaborate in a matrix environment.
    • Strategic thinking, analytical skills, and proficiency with Excel or statistical tools.
    • Excellent writing and communication skills, along with a sense of urgency and performance orientation.

    Physical Requirements/Working Conditions:

    • This role is based in Sun House, Mumbai, with occasional travel required for official work.

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