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    Contract Medical Writer

    Katalyst Healthcares & Life Sciences
    1-3 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: Contract Medical Writer

    Location: Remote
    Employment Type: Contract

    Company Overview:

    Katalyst Healthcares & Life Sciences is seeking entry-level candidates for multiple positions in contract research related to clinical trials of drugs, biologics, and medical devices. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners to provide expert services in Drug Safety, Pharmacovigilance, and Clinical Research.

    Position Overview:

    The Contract Medical Writer will author, edit, and deliver high-quality clinical documents across multiple therapeutic areas and products in Clinical Development. You will work cross-functionally with internal teams and external partners to produce regulatory documents for submission to global health authorities, ensuring compliance with all relevant regulations and guidelines.

    Key Responsibilities:

    • Clinical Document Preparation: Write and edit complex clinical documents, including protocols, amendments, Clinical Study Reports (CSRs), Investigator Brochures (IBs), briefing books, and responses to authorities.
    • Regulatory Submissions: Prepare regulatory documents, such as CTD (Common Technical Document) Module 2 and Module 5, in accordance with global guidelines (FDA, EMA, ICH, etc.).
    • Collaboration: Work closely with pre-clinical Subject Matter Experts (SMEs) to incorporate pre-clinical data into clinical and regulatory documents.
    • Scientific Writing: Write abstracts, manuscripts, posters, and presentations for scientific meetings and journals. Coordinate submissions to scientific meetings and journals.
    • Process Improvement: Contribute to the development and implementation of medical writing processes, templates, and style guides.
    • Ad-hoc Assignments: Perform other tasks and assignments as needed and specified by management.

    Qualifications & Experience:

    • Educational Requirements:
      • Advanced degree (PhD or PharmD) and a minimum of 5 years of medical writing experience in the pharmaceutical, biotechnology, or CRO industry; OR
      • Bachelor’s degree in a scientific discipline and a minimum of 8 years of medical writing experience in a pharmaceutical, biotechnology, or CRO environment.

    Skills & Knowledge:

    • Required:

      • Proven experience writing, editing, and formatting complex scientific/medical content in compliance with FDA and EMA/ICH guidelines.
      • Expertise in writing clinical protocols, CSRs, IBs, regulatory submission documents, and responses to health authorities.
      • Ability to analyze, write, and prepare clinical regulatory documents accurately and concisely.
      • Strong understanding of biostatistics reporting standards and concepts.
      • High attention to detail, ensuring correct formatting, logical flow, and document structure.
      • Proficiency with Microsoft Office, electronic document templates, and Adobe Acrobat.
      • Excellent written and verbal communication skills.
      • Strong organizational, planning, and time management skills.
      • Ability to work independently and collaboratively in a fast-paced, team-oriented environment.

    • Preferred:

      • Experience with IND and NDA/MAA submissions.
      • Broad knowledge of FDA, EMA, and ICH guidelines beyond regulatory document specifics.
      • Familiarity with PubMed and other reference-gathering search tools.
      • Proficiency with eCTD templates.

    Additional Information:

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

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