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    Principal Medical Writer

    Thermo Fisher Scientific
    8+ years
    Not Disclosed
    Remote
    10 Oct. 4, 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

    At Thermo Fisher Scientific, we’re dedicated to meaningful work that positively impacts lives globally. Join us in fulfilling our mission: enabling customers to make the world healthier, cleaner, and safer. We equip our teams with the resources they need to achieve their individual career goals while advancing research, development, and delivery of life-changing therapies. Our clinical trials span over 100 countries, and we are committed to developing innovative frameworks for clinical research through our PPD clinical research portfolio, encompassing laboratory, digital, and decentralized clinical trial services. Your dedication to quality and accuracy will enhance health outcomes for individuals and communities now and in the future.

    Position Overview:

    We are excited to expand our India Medical Writing FSP Team! We are seeking a Principal Medical Writer to work with a client in the FSP space. While experience in Immunology, Oncology, or Vaccines is valuable, it is not mandatory. In this role, you will deliver high-quality medical and scientific writing, overseeing everything from planning and coordination to the final delivery of drafts for internal and external clients. As the lead writer, you will review documents produced by the team and provide training and guidance to junior members. As a subject matter expert, you will advise on document development strategies, regulations, and industry best practices, collaborating with internal and external clients to foster effective communication and operational excellence.

    Key Responsibilities:

    • Research, write, and edit clinical study reports, study protocols, and summarize data from clinical studies.
    • Serve as the primary author for complex clinical, scientific, and program-level documents, including Investigator Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs). Provide senior-level reviews of routine and complex documents.
    • Train and mentor other writers and program managers on document preparation, software for document development, regulatory requirements, and therapeutic area knowledge.
    • Ensure compliance with quality processes and requirements for assigned documents. As the subject matter expert, develop and review best practices and lead process improvement initiatives.
    • Represent the department in project launch, review, and team meetings.

    Education and Experience:

    • Bachelor’s degree in a scientific discipline or equivalent; an advanced degree is preferred.
    • A minimum of 8 years of experience in a Medical Writing role.
    • Strong experience in authoring Clinical Study Reports (CSRs), protocols, IBs, Informed Consent Forms (ICFs), narratives, etc.
    • Proven experience managing and directing complex medical writing projects is required.
    • Experience in the pharmaceutical or CRO industry is preferred; familiarity with submissions documents is advantageous.
    • Additional qualifications in medical writing (e.g., AMWA, EMWA, RAC) are beneficial.

    Knowledge, Skills, and Abilities:

    • Comprehensive knowledge of global, regional, and national document development guidelines.
    • In-depth expertise in one or more specialty areas such as preclinical, therapeutic, regulatory, or communications.
    • Excellent data interpretation and medical writing skills, including grammar, editorial, and proofreading.
    • Strong project management and interpersonal skills, along with advanced oral and written communication abilities.
    • Exceptional judgment and independence in decision-making and problem-solving.
    • Ability to mentor and lead junior staff effectively.

    What We Offer:

    At PPD Clinical Research Services, we strive to hire the best and foster personal and professional growth. Our award-winning learning and development programs will help you reach your full potential. In addition to a competitive salary, we offer an extensive benefits package focused on employee health and well-being. We promote a flexible working culture that values work-life balance, ensuring a collaborative environment where colleagues share expertise and enjoy their work. As a global organization with a local feel, we are united by our mission to make the world healthier, cleaner, and safer.

    Join us at Thermo Fisher Scientific, where diverse experiences and perspectives are valued. #StartYourStory with us and be part of a team of over 100,000 colleagues dedicated to integrity, intensity, innovation, and involvement. Together, we accelerate research, tackle complex scientific challenges, drive technological innovation, and support patients in need.

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