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    Principal Medical Writer

    Thermo Fisher Scientific
    2+ years
    Not Disclosed
    Remote
    10 Oct. 30, 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

    Job Title: Principal Medical Writer
    Work Schedule: Other
    Environmental Conditions: Office

    Job Description:
    At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact globally. Join our dedicated team in bringing our mission to life—enabling our customers to make the world healthier, cleaner, and safer. We equip our teams with the resources necessary to achieve individual career goals while advancing research, development, and delivery of life-changing therapies. With clinical trials conducted in over 100 countries, our work encompasses laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will help improve health outcomes that communities depend on now and in the future.

    Summarized Purpose:
    We are expanding our India Medical Writing FSP Team and seeking a Principal Medical Writer dedicated to a client in the FSP space. Experience in Immunology, Oncology, or Vaccines is valuable but not essential. As a Principal Medical Writer, you will provide high-quality medical and scientific writing from planning through to the delivery of final drafts. You will lead document reviews and provide training and guidance to junior team members. As a subject matter expert, you will advise on document development strategy, regulations, and industry best practices, collaborating with internal and external clients to achieve operational excellence.

    Essential Functions:

    • Research, write, and edit clinical study reports, study protocols, and summarize clinical study data.
    • Serve as the primary author for complex clinical and scientific documents, including Investigator’s Brochures (IBs), INDs, and Marketing Authorization Applications (MAAs).
    • Provide senior-level reviews for routine and complex documents and mentor junior writers on document preparation and regulatory requirements.
    • Ensure compliance with quality processes for assigned documents, developing best practices and leading process improvement initiatives.
    • Represent the department at project launch meetings, review meetings, and project team meetings.

    Education and Experience:

    • Bachelor’s degree in a scientific discipline or equivalent; an advanced degree is preferred.
    • 8+ years of experience in a Medical Writing role, with strong experience in authoring CSRs, protocols, IBs, ICFs, and narratives.
    • Experience managing complex medical writing projects is required.
    • Previous experience in the pharmaceutical/CRO industry is preferred, with submissions document experience advantageous.
    • Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous.

    Knowledge, Skills, and Abilities:

    • Significant knowledge of document development guidelines at global, regional, and national levels.
    • In-depth knowledge in specialty areas such as preclinical, therapeutic, regulatory, and submissions.
    • Excellent medical writing skills, including grammar, editorial, and proofreading.
    • Strong project management and interpersonal communication skills.
    • Excellent negotiation abilities and judgment, with a high degree of independence in decision-making.
    • Ability to mentor and lead junior staff.

    What We Offer:
    At PPD clinical research services, we hire the best and promote a culture of development and collaboration. You'll benefit from an award-winning learning program that helps you reach your potential. Along with a competitive salary, we offer an extensive benefits package centered around employee health and well-being, flexible working conditions, and a collaborative environment where teams are eager to share expertise and enjoy their work together.

    Our mission is to enable our customers to make the world healthier, cleaner, and safer. Together, as one team of over 100,000 colleagues, we uphold values of Integrity, Intensity, Innovation, and Involvement, driving technological innovation and supporting patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences and perspectives are valued.

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