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    Sr Medical Writer - Fsp

    Thermo Fisher Scientific
    5+ years
    Not Disclosed
    Remote
    10 Sept. 11, 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

    Work Schedule
    Other

    Environmental Conditions
    Office (Remote)

    Job Description

    Senior Medical Writer (FSP; Remote - India)

    At Thermo Fisher Scientific, you’ll contribute to meaningful work that impacts a global scale. Join a team that embodies our mission of enabling customers to make the world healthier, cleaner, and safer. We empower our employees with resources to help them achieve individual career goals and push the boundaries of science through research, development, and the delivery of life-changing therapies. With clinical trials conducted in over 100 countries, you will be part of a diverse team delivering innovative clinical research solutions through our PPD portfolio. Your dedication to accuracy and quality will directly contribute to improving health outcomes for people and communities worldwide.

    Key Responsibilities:

    • Serve as the primary author for clients in the FSP (Functional Service Provider) space, writing and providing input on essential documents like clinical study reports and protocols, and summarizing clinical data.
    • Conduct research, write, and edit complex clinical and scientific documents, including Investigator Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs).
    • Review documents prepared by junior team members, providing training and mentorship on document preparation, regulatory requirements, and therapeutic area knowledge.
    • Ensure compliance with quality processes and regulatory requirements across all assigned documents, offering input to develop best practices.
    • Participate in program management activities, including developing timelines, budgets, forecasts, and handling contract modifications.
    • Represent the department in project launch and review meetings, ensuring alignment with client objectives.

    Qualifications:

    • Bachelor’s degree in a scientific discipline; an advanced degree is preferred.
    • Minimum of 5 years of regulatory writing experience, with hands-on experience in Clinical Study Reports (CSR), Protocols, IBs, Narratives, Summaries, and Regulatory Submissions.
    • Experience in peer reviews and quality review of medical writing documents.
    • Strong project management skills and a proven ability to handle complex projects.
    • Excellent interpersonal, communication, and negotiation skills.
    • In-depth knowledge of global, regional, and national guidelines related to document development.
    • Experience in mentoring or managing teams is advantageous.
    • Additional qualifications in medical writing (AMWA, EMWA, RAC) are a plus.
    • Experience in the pharmaceutical or CRO industry is preferred, particularly within FSP models.

    Why Join Us: At PPD Clinical Research Services, part of Thermo Fisher Scientific, we foster a culture of learning and growth, with an award-winning learning and development program designed to help you reach your full potential. We value work-life balance and offer a flexible working environment, competitive salaries, and an extensive benefits package focused on employee well-being. Although we are a global organization, our collaborative environment creates a local feel, where teamwork, expertise sharing, and fun are always encouraged.

    Our Mission:
    To make the world healthier, cleaner, and safer. As one team of over 100,000 colleagues, we live by our shared values of Integrity, Intensity, Innovation, and Involvement. We work together to drive research, solve complex scientific challenges, and support patients in need.

    Start your story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

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