Job Overview :
Labcorp are recruiting a Lead Medical Writer to work outsourced to one of our clients. Candidates can work home based in Manila.
It's key for candidates to have experience of signal detection / aggregate reporting for more than 5 years.
Role responsibilities will include but not limited to :
Conducting literature searches for authoring various types of reports.
Write and review various safety reports (or part of such reports) for global regulatory submissions, 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 5-8 years’ medical writing experience in the pharmaceutical industry
Experience of signal detection / aggregate reporting for more than 5 years.
Candidates must be able to communicate effectively in the English language.