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    Medical Writing Specialist

    Cornerstone Technology Talent Services
    3-5 years
    $40/hr - $45/hr
    Remote, USA
    10 Aug. 13, 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, 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

    Position Title: Medical Writing Specialist

    Schedule: Monday - Friday
    Location: Remote (Candidates must reside in AZ, FL, GA, IN, KY, NC, SC, TX)
    Contract Type: Long-Term

    Company: CornerStone TTS

    Overview:

    CornerStone TTS is seeking an experienced Medical Writing Specialist for a long-term remote contract role. In this crucial position, you will be responsible for preparing and overseeing regulatory submission documents that meet global regulatory standards. The ideal candidate will have substantial experience in medical writing within the pharmaceutical or biotech industry.

    Key Responsibilities:

    • Document Preparation: Write or oversee the preparation of clinical study reports and Investigator Brochures for products in all clinical development phases (1-4).
    • CTD Sections: Develop CTD sections, including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives.
    • Regulatory Submissions: Prepare various regulatory submission documents such as RTQs, PIPs, white papers, breakthrough therapy applications, and orphan drug applications.
    • Project Leadership: Lead study timelines and strategies for regulatory document preparation and submissions.
    • Functional Representation: Act as a functional area representative and leader on product teams.
    • Departmental Support: Assist with hiring, resourcing therapeutic areas, and departmental governance.
    • Quality Assurance: Ensure the quality of regulatory submission documents throughout all stages of development.
    • Mentorship: Provide expertise and guidance on document design and principles of good medical writing to the department and product teams.
    • Collaboration: Participate in departmental and cross-departmental meetings and initiatives.

    Basic Qualifications:

    • Education:

      • Doctorate degree, or
      • Master’s degree with 3 years of experience in writing regulatory or scientific submission/documents, or
      • Bachelor’s degree with 5 years of experience in writing regulatory or scientific submission/documents, or
      • Associate’s degree with 10 years of experience in writing regulatory or scientific submission/documents, or
      • High school diploma/GED with 12 years of experience in writing regulatory or scientific submission/documents.

    • Experience and Technical Proficiencies:

      • Advanced Education: Master’s degree or higher in biology, chemistry, or a related scientific field.
      • Industry Experience: 5+ years of experience in writing clinical and regulatory documents within the pharmaceutical or biotech industry.
      • Regulatory Knowledge: Advanced knowledge of scientific/technical writing and editing, with familiarity with relevant regulatory guidance (e.g., ICH) for regulatory submission documents and industry compliance.
      • Analytical Skills: Ability to analyze and interpret medical data.
      • Communication: Strong written and verbal communication skills with a keen attention to detail.
      • Project Management: Excellent time and project management skills with a results-driven approach.
      • Leadership: Proven leadership abilities and the capacity to guide and influence team members.
      • Interpersonal Skills: Effective in negotiation, persuasion, collaboration, and analytical judgment.

    Apply Now:

    To apply for this role, please visit our Career Page.

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