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Covance

Lead Medical Writer - PSS Job at Covance in Barre

Covance, Barre, MA, United States, 01005


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:

- Masters degree in Pharmacy/related science area

- Bachelors degree in Medical Science

Experience:

- At least 5-8 years medical writing experience in the pharmaceutical industry

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Experience of signal detection/aggregate reporting for more than 5 years.

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Candidates must be able to communicate effectively in the English language.