Lead Medical Writer

Job Location(s) IN-Pune | IN-Mumbai
Job Number
Job Category
Medical Writing
Position Type

Job Overview

- Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain and assume accountability for a culture of high customer service
- Efficiency in conducting literature searches for authoring various types of reports
- Write and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned.
- Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned..
- Write Investigator Brochures and sections of/entire protocols
- Write Clinical Study Reports (in whole or in part) for Phases 1-4 trials, including full study reports, abbreviated reports, web synopses, subject narratives
- Author Informed Consent Forms (ICFs), manuscripts, abstracts, posters for conferences.
- Resolve and/or escalate issues in a timely manner
- Timely escalation of unresolved issues to internal and external (client) point of contact
- Support and contribute to onboarding, training, mentoring, and coaching of new associates
- Prepare medical information responses for HCPs
- Act as a writing coach
- Coordinate activities related to various types of report writing across a team of writers if applicable
- Liaise with client and act as a primary point of contact for all report writing activities
- Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training
- Assist in estimation of resource requirement and responding to RFPs as needed
- Internal and external (client) communication & co-ordination to get the required inputs
- Get resolution on issues affecting project deliverables
- Creating and updating labels, , e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides
- Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document


- Master’s degree in Pharmacy/related science area
- Bachelor’s degree in Medical Science
- At least 5-7 years’ experience in the pharmaceutical industry, with at least 4 years of it in medical writing
- Experience in drug discovery and pharmacovigilance is desirable


- At least 5-7 years’ experience in the pharmaceutical industry, with at least 4 years of it in medical writing
 Experience in drug discovery and pharmacovigilance is desirable


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