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    • Medical Writer for Clinical Regulatory Documents - Oss - beBee Careers

    beBee Careers
    beBee Careers Oss

    6 dagen geleden

    beBee Careers background

    Functie: Freelance Principal Medical Writer

    Beschrijving

    Job Title: Medical Writer - Clinical Regulatory Documents

     

    Job Summary:

    We are seeking a highly experienced Principal Medical Writer to join our team. The successful candidate will be responsible for writing and editing clinical study reports, Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas.

     

    Responsibilities:

    • Write and edit clinical study reports, Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents

    • Review clinical protocols, Statistical Analysis Plans, Statistical Programming Plans, data tables and listings, and other clinical regulatory documents as needed

    • Lead the preparation of briefing documents, INDs, licensing submissions (BLAs, MAAs), and other complex clinical regulatory documents

    • Negotiate timeline development for preparation of clinical regulatory documents

    • Demonstrate critical thinking in the analysis and presentation of clinical study data

    • Lead the process of critical review of clinical regulatory documents and incorporate multiple reviews into successive drafts

    • Provide QC support for clinical regulatory documents as required

    • Review case report forms, statistical analysis plans, and data tables and listings for content and format

    • Assist with or lead the preparation or revision of SOPs, WPDs, and document templates

    • Participate in clinical project team meetings and cross-functional team meetings

    • Maintain and promote familiarity with ICH, GCP, and other standards

     

    Requirements:

    • An advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience is required

    • 6+ years of experience writing high-quality clinical and regulatory documents, including clinical study reports across multiple therapeutic areas

    • Experience writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions

    • Proficiency in Microsoft Office applications

    • Familiarity with CTD, ICH, GCP, and other standards

    • Pharmaceutical or biotechnological industry experience is required

    • Fluency in English (both oral and written) is required

     

    Additional Information:

    The ideal candidate will have strong analytical and problem-solving skills, excellent communication and project management skills, and the ability to work independently and collaboratively as part of a team.

     

    The selected candidate will be responsible for maintaining and promoting familiarity with relevant industry standards, such as ICH and GCP, and ensuring that all clinical regulatory documents meet the required quality and accuracy standards.

     

    We offer a competitive compensation package and opportunities for professional growth and development.

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