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    Medical Writer Iii

    Aequor
    3+ years
    $90/hr - $100/hr
    Princeton Junction 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: Associate Director, Medical Writing

    Location: Remote

    Position Summary:

    The Associate Director of Medical Writing will lead key medical writing projects across various therapeutic areas, focusing on the preparation of scientific and regulatory documents related to investigational and marketed drugs and biologics. This role involves minimal supervision and includes the preparation of clinical study reports (CSRs), subject narratives, investigator brochures, protocols, briefing documents, and sections of INDs, NDAs, and BLAs. The Associate Director will leverage extensive experience in pharmaceutical medical writing and clinical development to ensure the accuracy and compliance of all regulatory documentation.

    Key Responsibilities:

    • Document Preparation: Lead the creation of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents required for regulatory submissions.
    • Submission Strategy: Contribute to the development of submission communication strategies for products.
    • Data Interpretation: Accurately interpret and summarize data from biostatistical summary tables and listings into clear, concise narrative text.
    • Internal Coordination: Liaise with internal teams, including Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations, and R&D Management, to gather necessary information and ensure timely document production.
    • Team Oversight: Manage and review the work of other medical writers, including freelance/contract writers and agencies, with support from the Director of Medical Writing.
    • Process Improvement: Foster innovation and improvements in medical writing processes and documents.
    • Other Duties: Perform additional tasks as assigned, based on project needs.

    Scope:

    • Complex Problem Solving: Use professional concepts and company objectives to resolve complex issues creatively and effectively.
    • Decision Making: Determine methods and procedures for new assignments, working on complex issues that require in-depth evaluation of data and situations.

    Physical Requirements:

    • Regularly required to stand, walk, sit, use hands to handle or feel, reach with hands and arms, and occasionally lift/move up to 20 pounds.
    • Occasional overnight travel may be required.
    • Must be able to perform duties independently from remote locations and in a standard office environment.

    Required Qualifications:

    • Education: PhD in a life science or Pharm D preferred; MS with 7+ years of relevant experience.
    • Experience: At least 3 years in medical writing within the pharmaceutical industry, focusing on regulatory document preparation and drug development processes.
    • Specific Knowledge: Experience with CNS/Neuroscience compounds is preferred.
    • Skills:
      • Strong writing skills with the ability to translate complex scientific data into clear, well-structured narratives.
      • Knowledge of US, ICH, and international regulations for regulatory document preparation and submissions.
      • Proficiency with electronic document management and publishing systems.
      • Ability to quickly assimilate information and produce high-quality summaries and reports.
      • Familiarity with Common Technical Document content templates and regulatory documentation for IND/NDA/MAA submissions.
      • Excellent command of software programs in a Windows environment, including word processing, flow diagrams, and spreadsheets.

    Preferred Qualifications:

    • Certification: AMWA certification or similar, with a focus on Pharmaceutical Writing.
    • Experience: Previous work in journalism or press publications is a plus.
    • Additional Skills: Ability to lead projects independently, manage cross-functional teams, and create a collaborative team environment.

    Languages:

    • Proficiency in English (spoken, read, written).

    To Apply:

    If you meet the qualifications and are interested in this opportunity, please submit your application today.

    Supplier FLSA Classification: N/A

    H-1B Status: Not eligible

    Job Code: Medical Writer III

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