Senior Medical Writer

5+ years

Not Disclosed

Remote, USA

10 Aug. 7, 2024

Job Description

Job Type: Full Time 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

About the Job

Our client is seeking a Senior Medical Writer to handle various regulatory writing projects. This role requires staying updated on current medical writing and regulatory standards, including Good Clinical Practice (GCP), and advancements in clinical drug development.

Key Responsibilities:

Prepare all assigned documents, ensuring they meet requirements and full scope, templates, and specifications. Negotiate and adhere to timelines, organize document reviews, and communicate directly with the customer.
Organize assigned projects and tasks, identify all project needs, track timelines, and respond promptly to customer requests.
Present Medical Writing processes at bid defense meetings.
Complete project finance activities, including monitoring and forecasting budgeted hours.
Propose, review, and approve budgets and costings for routine projects, including estimating hours needed for Medical Writing tasks.

Key Skills:

Bachelor’s Degree in life sciences
5 years of highly relevant experience, including acting as lead writer for CSRs & CSP
Strong knowledge of the structure and content requirements of CSRs, protocols, and similar documents, with a keen eye for identifying errors and inconsistencies
Good understanding of common statistical methods used in clinical trials and interpretation of their results

Location:

100% remote-based, anywhere in the USA.

For more information, contact nicki@leamanlifesciences.com or fatlum@leamanlifesciences.com, or click "Easy Apply".

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Senior Medical Writer

Job Description

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