Lead Medical Writer - PSS
Labcorp Drug Development
Manila, Philippines
6d ago

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
  • Experience :

  • 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.

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