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    Med Writer

    Thermo Fisher Scientific
    2-5 years
    Not Disclosed
    Remote
    10 Sept. 26, 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

    Position Overview

    We are seeking a skilled Regulatory Medical Writer to provide high-quality writing and technical consultation for both internal and external clients. This role involves substantial expertise in therapeutic areas and industry regulations, allowing you to manage medical writing projects effectively and deliver quality products within agreed timelines. You will collaborate with various stakeholders to ensure smooth communication and operational excellence.

    Essential Duties and Responsibilities:

    • Independently research, write, and edit clinical study reports, study protocols, informed consent forms, and other regulatory documents related to peri- and post-approval processes. Support the creation of complex scientific documents, including Investigator's Brochures (IBs) and sections of INDs, NDAs, and CTDs.
    • Manage all project aspects, including planning, organizing, and executing tasks without supervision. This includes developing project timelines, standards, budgets, and contract modifications. Collaborate with functional units like project management, clinical, QA, data management, biostatistics, and regulatory affairs.
    • Analyze diverse data to address complex problems and evaluate identifiable factors.
    • Interact with internal and external personnel on significant matters, coordinating across functional areas and networking with senior stakeholders in your area of expertise.
    • Operate with minimal supervision on routine tasks, receiving general guidance on new assignments while demonstrating sound judgment in selecting methods and techniques for problem-solving.
    • Represent the department as the primary contact for projects during launch meetings, review sessions, client audits, and capabilities presentations. Build and maintain client relationships, initiating and leading interactions independently.
    • Assist with business development efforts, including budget development and proposal creation.

    Education, Professional Skills & Experience:

    • Bachelor's degree in a scientific discipline or equivalent relevant qualification; advanced degree preferred.
    • A minimum of 2-5 years of writing experience in a relevant field or a combination of education, training, and experience that equips you for the role.
    • Preferred experience in the pharmaceutical or CRO industry.
    • Additional qualifications in medical writing (e.g., AMWA, EMWA, BELS, RAC) are a plus.
    • Strong knowledge of global, regional, and national document development guidelines.
    • In-depth expertise in a specialty area, such as therapeutic areas, regulatory submissions, or healthcare communications.
    • Proficient computer skills and familiarity with client templates, document management systems, and applications like Excel and Outlook.

    Personal Skills & Competencies:

    • Exceptional written English skills, with the ability to effectively communicate and document information, producing well-organized and error-free documents tailored to the audience.
    • Strong numerical aptitude for manipulating and formatting data to provide insights and evidence.
    • Capable of analyzing complex issues, identifying information gaps, establishing cause-effect relationships, and proposing effective solutions.
    • Proficient in creating and managing project plans that align with overall objectives, guiding team members and monitoring progress methodically.
    • Demonstrates sound professional judgment in addressing inquiries, issues, and escalations, and effectively resolves conflicts among team members and clients through active listening and collaboration.

    Join us to make a significant impact in the field of regulatory medical writing and contribute to advancing healthcare solutions.

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