What are the responsibilities and job description for the Lead Medical Writer - PSS Job at Covance in Barre position at Covance?
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 SPCs, Med Guides.
- Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting / justification document.
Education / Qualifications :
Experience :
Experience of signal detection / aggregate reporting for more than 5 years.
Candidates must be able to communicate effectively in the English language.
