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    Contract Medical Writer

    Katalyst Healthcares & Life Sciences
    2+ years
    Not Disclosed
    Remote
    10 Nov. 21, 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: Contract Medical Writer
    Company: Katalyst Healthcares & Life Sciences
    Location: Remote, OR
    Contract Type: Contract

    Company Overview:

    Katalyst Healthcares & Life Sciences specializes in clinical research across drugs, biologics, and medical devices. We collaborate with leading universities, hospitals, pharmaceutical companies, and recruiting partners to provide high-quality research and regulatory services. We are currently hiring entry-level candidates and experienced professionals in Drug Safety, Pharmacovigilance, and Clinical Research.

    Role Overview:

    We are seeking a Contract Medical Writer to work remotely, authoring and editing high-quality clinical documents for regulatory submission. This position involves working cross-functionally with internal departments and external resources to create clinical documents for various therapeutic areas, ensuring compliance with regulatory guidelines, and meeting the needs of health authorities.

    Responsibilities:

    • Document Preparation: Write and edit complex clinical documents, such as protocols, clinical study reports (CSRs), Investigator Brochures (IBs), and regulatory submission documents, including CTD Modules 2 and 5.
    • Regulatory Compliance: Ensure all documents are compliant with regulatory standards, including FDA, EMA, and ICH guidelines, as well as company SOPs and internal style guides.
    • Collaboration: Work with subject matter experts (SMEs) to incorporate pre-clinical data into clinical and regulatory documents.
    • Scientific Writing: Write abstracts, manuscripts, and presentations for scientific meetings, as well as manuscripts for publication in scientific journals.
    • Process Improvement: Contribute to the development of medical writing processes, templates, and style guides.
    • Other Tasks: Perform other assignments as directed by management.

    Requirements:

    • Education: Advanced degree (PhD or PharmD) with a minimum of 5 years of medical writing experience, OR a Bachelor’s degree with at least 8 years of experience in the pharmaceutical, biotechnology, or CRO industry.
    • Experience: Proven experience writing clinical protocols, CSRs, IBs, regulatory submission documents, and manuscripts. Familiarity with FDA, EMA, and ICH guidelines.
    • Skills:
      • Expertise in writing and editing scientific and regulatory documents.
      • Strong understanding of biostatistics reporting standards.
      • Excellent attention to detail and proficiency with Microsoft Office and electronic document templates.
      • Ability to work independently and in a team environment.
      • Strong communication, organizational, and time management skills.

    Preferred Skills:

    • Experience with IND, NDA/MAA submissions.
    • Familiarity with Adobe Acrobat and eCTD templates.
    • Knowledge of PubMed and reference-gathering tools.

    Why Katalyst Healthcares & Life Sciences?

    • Work remotely with a collaborative team in a fast-paced, dynamic environment.
    • Competitive contract rates and flexible work arrangements.
    • Opportunity to contribute to impactful clinical research in the healthcare and life sciences industry.

    Apply Now: Katalyst Healthcares Careers

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