Covance

Lead Medical Writer

Job Location(s) IN-Pune | IN-Mumbai
Job Number
2021-75349
Job Category
Medical Writing
Position Type
Full-Time
Telecommute
Yes

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
 
 

Education/Qualifications

- 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

Experience

- 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

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed