Senior Medical Writer, Early Phase Single Sponsor Support

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Job Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Leads the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols and protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including ICH E3 guidelines, as well as company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides.
• Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Leads team document reviews, and acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, format, and consistency.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate.
• Provides technical support, training, and consultation to department and other company staff.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Aware of budget specifications for assigned projects, working within budgeted hours and communicating status and changes to medical writing leadership.

Minimal travel may be required (less than 25%).

Qualifications

• 3-5 years of relevant experience in regulatory writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of EMA, FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
• Experience writing relevant document types required.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.

Over the past 5 years, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.