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    Sr Medical Writer - Regulatory

    Syneos Health
    5+ years
    Not Disclosed
    Remote
    10 Dec. 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

    Sr. Medical Writer - Regulatory
    Updated: December 18, 2024
    Location: India-Asia Pacific - IND-Gurugram-DLF Downtown, India
    Job ID: 24006762-IND501

    Job Description

    Senior Medical Writer - Regulatory

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

    Our Clinical Development model places the customer and patient at the center of everything we do. We are constantly striving to simplify and streamline our processes to not only make Syneos Health easier to work with, but also to make us a better place to work for.

    Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers and innovators to help our customers achieve their goals. We are agile, driven, and dedicated to accelerating the delivery of therapies because we are passionate about changing lives.

    Discover why our 29,000 employees across 110 countries know that:

    WORK HERE MATTERS EVERYWHERE

    Why Syneos Health

    We are passionate about developing our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters authenticity, uniting us globally while providing an environment where everyone can feel like they belong.

    Job Responsibilities

    • Lead and independently manage the end-to-end development of regulatory documents for assigned medical writing projects.
    • Oversee and coordinate medical writing activities for individual studies, ensuring minimal supervision and smooth collaboration within and across departments.
    • Interact with internal and external stakeholders, participate in meetings, present to clients, and independently lead and conduct Kick-Off Meetings (KOMs) and review sessions with study teams.
    • Mentor and guide less experienced medical writers on complex projects.
    • Develop or support a variety of documents, including:
      • Clinical study protocols and amendments.
      • Clinical study reports (CSRs).
      • Informed consent forms and assent forms.
      • Patient narratives.
      • IND submissions and annual reports.
      • Investigator brochures (IB) and updates.
    • Identify and propose solutions to resolve issues during the writing process, escalating when necessary.
    • Review statistical analysis plans and ensure content accuracy, grammar, format, and consistency.
    • Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams to produce writing deliverables.
    • Serve as a peer reviewer, providing feedback on drafts and final documents.
    • Adhere to regulatory standards (e.g., ICH-E3 guidelines) and company SOPs, ensuring timely and on-budget completion of medical writing projects.
    • Conduct online clinical literature searches as necessary.
    • Stay informed about current industry practices and regulatory requirements impacting medical writing.
    • Monitor project budgets, ensuring alignment with allocated hours and communicate any necessary changes to medical writing leadership.
    • Complete administrative tasks within specified timeframes.
    • Other duties as assigned. Minimal travel may be required (less than 25%).

    Qualifications

    What We’re Looking For:

    • A Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree (Social Sciences, English, or Communications preferred), with scientific and/or medical expertise.
    • 5+ years of experience as a medical writer or in a relevant role.
    • Experience in preparing CSRs, protocols, IBs, informed consent forms, clinical summaries, and clinical overviews.
    • Extensive knowledge of English grammar, FDA and ICH regulations, and familiarity with the AMA style guide.
    • Ability to work independently with strong presentation, proofreading, interpersonal, and leadership skills.
    • Proficiency in Microsoft Word, Excel, PowerPoint, email, and internet use.
    • Understanding of clinical research principles and the ability to interpret and present complex clinical data.

    Get to Know Syneos Health

    Over the past five years, Syneos Health has worked with 94% of all Novel FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites with 675,000+ trial patients.

    We encourage initiative and challenge the status quo in a highly competitive, ever-evolving environment. Learn more about Syneos Health and the difference we’re making in the world of biopharmaceuticals.

    Additional Information

    The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may, at its discretion, assign other tasks or responsibilities. Equivalent experience, skills, and/or education will also be considered. All job descriptions are intended to comply with applicable legislation and promote equal opportunities in recruitment and employment practices.

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