Sr Medical Writer - Regulatory

Syneos Health

5+ years

Not Disclosed

Remote

10 Dec. 24, 2024

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

Senior Medical Writer - Regulatory

Company: Syneos Health®
Location: Flexible, with potential for minimal travel (less than 25%)

About Syneos Health:
Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success in clinical development, medical affairs, and commercial services. With a focus on patient-centered solutions, we leverage our expertise and global reach to deliver the therapies that change lives.

Our Total Self culture promotes diversity, inclusion, and personal well-being. At Syneos Health, we aim to build a workplace where employees can authentically be themselves and thrive.

Why Syneos Health?

We support career development through mentorship, training, and peer recognition.
A commitment to a positive workplace culture that fosters innovation and collaboration.
A global reach, working in over 110 countries, bringing diverse ideas and perspectives.

Job Responsibilities:

Lead Regulatory Writing Projects: Independently manage the end-to-end development of regulatory documents with minimal oversight.
Collaborate with Stakeholders: Work closely with internal and external teams, leading meetings with study teams, clients, and providing input in discussions.
Mentor Junior Writers: Lead and guide less experienced medical writers on complex projects.
Document Development: Produce clinical study protocols, study reports, informed consent forms, patient narratives, IND submissions, investigator brochures, and more.
Problem Solving: Identify and resolve issues during the writing process, ensuring that all regulatory standards are met.
Review and Quality Control: Review statistical analysis plans and related documents for content accuracy, grammar, format, and consistency.
Adhere to Standards: Follow industry regulations (e.g., ICH-E3 guidelines) and company SOPs, ensuring documents are submitted on-time and on-budget.
Literature Searches & Research: Conduct clinical literature searches and stay current with regulatory guidelines.
Budget Management: Monitor project budgets and report on any changes or needs.

Qualifications:

Education:
- Bachelor of Science (BS) in a relevant field (e.g., life sciences), or a Bachelor of Arts (BA) in Social Sciences, English, or Communications with relevant scientific knowledge.
Experience:
- 5+ years of medical writing experience or equivalent.
- Proficiency in writing clinical study reports (CSRs), protocols, investigator brochures (IBs), informed consent forms, and clinical summaries/overviews.
Skills:
- Expertise in English grammar and familiarity with FDA, ICH, and AMA style guidelines.
- Strong attention to detail, with effective proofreading, presentation, and interpersonal skills.
- Proficiency in Microsoft Word, Excel, PowerPoint, email, and internet tools.
- Ability to interpret and present complex clinical data.
- Strong leadership and mentoring abilities.

Why Join Us?

Impactful Work: Contribute to the approval of life-changing therapies and make a real impact in patients' lives.
Global Exposure: Work with diverse teams across the globe, gaining experience in multiple therapeutic areas.
Career Development: Grow your career within a company that values your personal and professional development.

Syneos Health is an equal opportunity employer. We are committed to creating a diverse, inclusive environment and providing reasonable accommodations to qualified individuals with disabilities.

Apply today to join Syneos Health and be part of a team dedicated to changing lives.

For more information about career opportunities, visit our website at Syneos Health Careers.

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Sr Medical Writer - Regulatory

Job Description

Job Responsibilities:

Qualifications:

Why Join Us?

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