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Senior Medical Writer

Leaman Life Sciences
Leaman Life Sciences
5+ years
Not Disclosed
10 Aug. 7, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Medical Writer

Location: Remote (Anywhere in the USA)

About the Job:

My client is seeking a Senior Medical Writer to handle a variety of regulatory writing projects. The ideal candidate will stay updated on medical writing practices, regulatory knowledge, and advances in clinical drug development, including Good Clinical Practice (GCP).

Key Responsibilities:

  • Prepare and manage assigned documents, ensuring requirements, templates, and specifications are met. Negotiate and adhere to timelines, organize document reviews, and communicate directly with clients.
  • Oversee project organization, track timelines, and address customer requests promptly.
  • Present Medical Writing processes at bid defense meetings.
  • Manage project finances by monitoring and forecasting budgeted hours. Propose, review, and approve budgets and costings for routine projects, including estimating hours required for Medical Writing tasks.

Key Skills:

  • Bachelor’s Degree in Life Sciences
  • 5+ years of relevant experience, including leading writing for Clinical Study Reports (CSRs) and Clinical Study Protocols (CSPs)
  • Strong understanding of CSR and protocol structures, content requirements, and attention to detail to identify errors and inconsistencies
  • Knowledge of common statistical methods used in clinical trials and ability to interpret their results

Additional Information:

  • This position is 100% remote, available to candidates anywhere in the USA.

For more information, please contact:
Nicki at nicki@leamanlifesciences.com
Fatlum at fatlum@leamanlifesciences.com
Or click "Easy Apply"