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    Med Writer

    Thermo Fisher Scientific
    2-5 years
    Not Disclosed
    Remote
    10 Oct. 7, 2024
    Job Description
    Job Type: 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 Description

    Position Overview:

    We are seeking a skilled regulatory medical writer to deliver high-quality documentation for both internal and external clients. In this role, you will provide technical consultation and strategic advice on regulations and industry best practices, demonstrating expertise in various therapeutic areas. You will effectively manage medical writing projects to ensure timely delivery of quality products while fostering collaboration with clients for operational excellence.

    Essential Duties and Responsibilities:

    • Independently research, write, and edit peri-/post-approval clinical study reports, study protocols, informed consent forms, and other regulatory documents. Support the development of complex clinical or scientific documents, including Investigator’s Brochures (IBs) and sections of INDs, NDAs, and CTDs.
    • Manage all aspects of project planning and execution, including timeline development, standards, budgets, forecasts, and contract modifications. Collaborate with functional units such as project management, clinical, QA, data management, biostatistics, and regulatory affairs.
    • Identify and escalate out-of-scope project activities in a timely manner, proposing effective solutions.
    • Address diverse problems requiring data analysis and evaluation of identifiable factors.
    • Interact with internal and external personnel on significant matters, facilitating coordination between functional areas and networking with senior personnel in your area of expertise.
    • Operate with minimal supervision on daily tasks and receive general instructions for new assignments, demonstrating sound judgment in selecting methods and techniques for solutions.
    • Serve as the primary contact for projects, participating in project launch meetings, review meetings, client audits, bid defenses, and capabilities presentations. Develop and maintain client relationships and lead interactions independently. Assist with business development and the preparation of budgets and proposals.

    Education, Professional Skills & Experience:

    • Bachelor's degree in a scientific discipline or equivalent, with advanced degrees preferred.
    • A minimum of 2-5 years of relevant writing experience in the pharmaceutical or CRO industry, or an equivalent combination of education and training.
    • Additional qualifications in medical writing (e.g., AMWA, EMWA, BELS, RAC) are advantageous.
    • Extensive knowledge of global, regional, and national document development guidelines.
    • In-depth expertise in a specialty area, such as therapeutic, regulatory submissions, or healthcare communications.
    • Proficient in relevant software applications (e.g., Microsoft Excel, Outlook) and document management systems.

    Personal Skills & Competencies:

    • Exceptional written English skills, with the ability to produce clear, well-organized, and error-free documentation tailored to the audience's needs.
    • Aptitude for working with and formatting numerical data to provide evidence and insights.
    • Strong analytical skills to identify issues, information gaps, and cause-effect relationships, leading to effective solutions.
    • Ability to create and manage comprehensive project plans, guiding team members and reporting progress methodically to achieve project objectives.
    • Demonstrate professional judgment in addressing and resolving inquiries, issues, and escalations.
    • Skilled in conflict resolution, capable of facilitating discussions among team members and clients to achieve successful outcomes.

    If you meet these qualifications and are eager to contribute to impactful projects, we encourage you to apply!

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