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Principal Medical Writer (Csr, Ib,Protocol)

0-2 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Full Time Education: BA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here’s the rewritten job description along with a unique slug:


Principal Medical Writer (CSR, IB, Protocol) – India (Remote) | principal-medical-writer-india

About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions company, committed to accelerating customer success. By combining clinical, medical affairs, and commercial expertise, we transform insights into impactful outcomes to navigate today’s dynamic market landscape.

At Syneos Health, the patient and customer remain at the core of our Clinical Development model. We constantly strive to enhance efficiency, making collaboration seamless and simplifying processes for both our employees and clients.

Whether you work in a Functional Service Provider partnership or a Full-Service setting, you’ll join a team of driven problem-solvers, working together to deliver innovative solutions that transform lives.

Join our 29,000 employees across 110 countries and discover why WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?

  • Career development and progression opportunities
  • Strong support through engaged line management and peer recognition
  • Comprehensive training in technical and therapeutic areas
  • A culture of diversity, authenticity, and inclusion

Key Responsibilities

  • Lead and mentor less experienced medical writers on complex projects.
  • Represent the Medical Writing department in clinical study teams, conferences, and client meetings.
  • Advise clients and teams on data presentation strategies, ensuring quality and compliance.
  • Develop and manage medical writing activities for clinical studies with minimal supervision.
  • Create and review key documents, including:
    • Clinical study protocols and amendments
    • Clinical study reports
    • Patient narratives
    • Clinical development plans
    • IND submissions and annual reports
    • NDA and (e)CTD submissions
    • Investigator brochures
    • Clinical journal manuscripts, abstracts, and client presentations
  • Review statistical analysis plans for accuracy and consistency.
  • Provide peer review feedback to enhance clarity, accuracy, and quality.
  • Ensure compliance with regulatory standards (e.g., ICH-E3), company SOPs, and client guidelines.
  • Conduct online clinical literature searches as needed.
  • Stay updated on regulatory guidance and industry expectations.
  • Monitor project budgets, ensuring work is completed on time and within allocated hours.
  • Perform additional duties as assigned; minimal travel required (less than 25%).

Qualifications & Skills

  • Bachelor's degree in Science, English, Communications, or a related field.
  • Strong knowledge of English grammar; familiarity with AMA style guide preferred.
  • Understanding of FDA and ICH regulations and guidelines.
  • Effective communication, presentation, and proofreading skills.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and relevant software tools.
  • Ability to interpret and present complex clinical data.

About Syneos Health

With extensive experience in clinical research, we have contributed to:

  • 94% of all Novel FDA Approved Drugs
  • 95% of EMA Authorized Products
  • 200+ Studies across 73,000 Sites and 675,000+ Trial patients

At Syneos Health, you’ll be part of an environment that challenges the status quo and fosters innovation in a highly competitive industry.

Ready to make an impact? Apply today!