Sr. Principal Medical Writer - Regulatory Submission Docs; ISE​/ISS​/Clinical Overview - Hav

Principal Medical Writer – Regulatory Submission Docs (ISE/ISS/Clinical Overview – Must Have) – Oncology Preferred

• Develop regulatory documents for submission to regulatory agencies globally—including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews—in accordance with ICH and other global guidelines, standards, and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams as necessary) and communicating with cross‑functional team members to maintain awareness of review cycles and expectations.
• Participate in cross‑functional meetings to provide input regarding medical writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
• eCTD submission experience preferred.

• Company car or car allowance
• Health benefits, including Medical, Dental, and Vision
• Company match 401(k)
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time (note: eligibility for paid sick time may vary by location)

USD 95,000.00 – . The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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.