Senior Medical Writer

5+ years

Not Disclosed

Remote, USA

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"

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Senior Medical Writer

Job Description

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