Sr Medical Writer - Regulatory

2+ 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-Home-Based, India
Job ID: 24006762

Job Description

Senior Medical Writer - Regulatory

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We convert unique clinical, medical affairs, and commercial insights into actionable outcomes to address modern market realities.

Our Clinical Development model centers the customer and the patient in everything we do. We are continually striving to simplify and streamline our operations to not only make Syneos Health easier to work with, but also a better company to work for.

Join us and collaborate with passionate problem-solvers in a dynamic, team-driven environment. We’re committed to driving innovation in the delivery of therapies, as we passionately strive to change lives.

Why Syneos Health

We are committed to the growth of our people, offering career development, supportive line management, technical and therapeutic area training, peer recognition, and a comprehensive rewards program. Our "Total Self" culture encourages authenticity, embracing diverse thoughts, backgrounds, and perspectives to foster a sense of belonging.

Job Responsibilities

Lead and manage end-to-end development of regulatory documents with minimal oversight.
Oversee medical writing activities related to individual studies, coordinating across departments with minimal supervision.
Engage with internal and external stakeholders, including participating in meetings and presenting to clients. 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 various 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 resolve issues during the writing process, escalating as appropriate.
Review statistical analysis plans and ensure content accuracy, grammar, and consistency.
Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams as needed.
Serve as a peer reviewer, providing feedback on drafts and final documents.
Adhere to regulatory standards (e.g., ICH-E3 guidelines) and company SOPs when completing writing projects, ensuring timely and on-budget delivery.
Conduct clinical literature searches as needed.
Stay up-to-date on industry practices, regulatory requirements, and guidelines.
Maintain awareness of project budgets, ensuring alignment with allocated hours and communicating changes as necessary.
Perform required administrative tasks within specified timeframes.
Other duties as assigned, with minimal travel (less than 25%).

Qualifications

What We’re Looking For:

A Bachelor of Science degree with relevant writing experience, or a Bachelor of Arts degree in 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 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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Sr Medical Writer - Regulatory

Job Description

Job Description

Why Syneos Health

Job Responsibilities

Qualifications

Get to Know Syneos Health

Additional Information

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