Medical Writer

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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Medical Writer

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