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    Medical Writer

    Katalyst Healthcares & Life Sciences
    0-2 years
    Not Disclosed
    Remote, USA
    10 Nov. 11, 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, CPC Certified, 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

    Job Title: Medical Writer

    Location: Remote, OR
    Employment Type: Contract

    Company Overview:

    Katalyst Healthcares & Life Sciences is currently hiring entry-level candidates for several contract research positions in clinical trials, specifically in the fields of drug safety, pharmacovigilance, and clinical research. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners to support the development of drugs, biologics, and medical devices.

    Position Overview:

    We are seeking an experienced Medical Writer to join our team on a contract basis. In this role, you will be responsible for writing, editing, and formatting regulatory documents, publications, and presentations, particularly for NDA submissions. Your experience with regulatory documents such as Mod 2.5, 2.7, and other submission content will be critical to ensuring high-quality deliverables. The position is remote, but candidates based on the East Coast are preferred.

    Key Responsibilities:

    • Clinical/Medical Writing: Write and edit regulatory documents including NDA submissions, briefing documents, SOPs, and style guides.
    • Document Review: Coordinate document review cycles, incorporate comments, and ensure the timely collection of signatures for finalization.
    • Collaboration: Work closely with internal clinical SMEs to bring together submission content and produce high-quality regulatory documentation.
    • Timelines and Management: Develop and maintain timelines for document review and finalization.
    • Quality Control: Provide QC review of regulatory documents to ensure accuracy and compliance.
    • Inter-Departmental Coordination: Collaborate with various teams and effectively represent the Medical Writing/Clinical Regulatory function.

    Qualifications & Skills:

    • Education: A minimum of a BS degree in a related field.
    • Experience:
      • 3+ years of experience in a pharmaceutical, biotech, or CRO environment.
      • Strong background in medical writing and clinical regulatory documents (IND, NDA, briefing books, DSUR, literature writing).
      • Recent experience with NDA submissions is highly desirable.
    • Knowledge & Expertise:
      • Solid understanding of FDA and ICH guidelines.
      • Strong writing skills for various clinical and regulatory documents.
      • Experience with clinical research concepts and the ability to interpret clinical data.
      • Familiarity with Pfizer systems is a plus.
    • Skills:
      • Strong project management and organizational skills.
      • Ability to work in a high-volume, fast-paced environment with multiple tasks.
      • Excellent time management and ability to prioritize.
      • Expertise in Word, PowerPoint, Excel, and other MS Office tools.
      • Excellent verbal and written communication skills.
      • Knowledge of electronic publishing is a plus.
      • Proven ability to collaborate seamlessly with clients in a consulting environment.

    Additional Information:

    All personal information will be kept confidential in accordance with EEO guidelines.

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