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Sr Medical Writer - Regulatory

5+ years
Not Disclosed
10 Dec. 22, 2024
Job Description
Job Type: Full Time Education: 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

Position: Senior Medical Writer - Regulatory
Company: Syneos Health®

Role Overview:
Syneos Health is seeking a skilled Senior Medical Writer with expertise in regulatory documents to join our team. This role involves independently managing the development of high-quality medical writing deliverables while adhering to industry standards and timelines. The ideal candidate will bring extensive experience in regulatory medical writing, including clinical study protocols, reports, and investigator brochures, as well as demonstrated leadership in mentoring less experienced writers.


Key Responsibilities:

  • Lead and manage the development of regulatory documents such as clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), IND submissions, and annual reports.
  • Serve as the primary point of contact for medical writing activities, ensuring seamless coordination across departments and with clients.
  • Participate in and independently lead kickoff meetings (KOMs), client reviews, and team presentations.
  • Mentor and support junior medical writers on complex projects.
  • Review and ensure statistical analysis plans and associated documentation meet content, grammar, and consistency standards.
  • Conduct peer reviews of deliverables, providing constructive feedback to enhance quality.
  • Perform clinical literature searches as needed to support document preparation.
  • Maintain knowledge of regulatory guidelines, including ICH-E3 and FDA regulations, and adhere to company SOPs and approved templates.
  • Manage projects within budgeted hours, communicating changes to leadership as necessary.
  • Stay informed on industry practices and updates that impact medical writing.
  • Complete administrative tasks and other work-related duties within specified timeframes.

Qualifications:

  • Education: Bachelor of Science in a related field or Bachelor of Arts (e.g., Social Sciences, English, Communications) with relevant scientific/medical knowledge.
  • Experience:
    • 5+ years in medical writing or equivalent roles.
    • Strong experience in creating CSRs, protocols, IBs, ICFs, and clinical summaries/overviews.
  • Proficiency in English grammar and familiarity with FDA and ICH guidelines and AMA style.
  • Proven ability to work independently and lead projects with minimal supervision.
  • Excellent presentation, proofreading, and interpersonal skills.
  • Strong leadership and team-oriented approach.
  • Technical proficiency in Microsoft Word, Excel, PowerPoint, and internet research tools.
  • Familiarity with principles of clinical research and the ability to interpret complex clinical data.

Why Syneos Health?
At Syneos Health, we prioritize career growth, supportive management, and recognition programs. Our Total Self culture encourages authenticity and inclusivity, fostering an environment where diverse thoughts and perspectives thrive. Collaborate with passionate professionals to deliver impactful solutions and advance healthcare globally.


Additional Information:
This job description outlines the core responsibilities and qualifications. The company reserves the right to assign other tasks or redefine roles based on business needs. Syneos Health is committed to diversity, equality, and providing reasonable accommodations in compliance with applicable laws.

Join Syneos Health, where "Work Here Matters Everywhere."