[Hiring] Senior Principal Medical Writer @Syneos Health

Role Description

Develop regulatory documents for submission to regulatory agencies globally, including:

• Clinical Study Reports
• Clinical Summaries of Efficacy and Safety
• Clinical Overviews

Ensure compliance with ICH and other global guidelines, standards, and processes, as well as Incyte authoring standards, in adherence with study/project timelines and corporate objectives.

• Manage medical writing projects, including developing timelines and communication with cross-functional team members.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables and timelines.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans).

eCTD submission experience preferred.

Qualifications

• Experience in regulatory document development.
• Strong understanding of ICH and global guidelines.
• Ability to manage timelines and communicate effectively with cross-functional teams.

Requirements

• Proven experience in medical writing.
• Ability to review and provide input on related documents.
• eCTD submission experience preferred.

Benefits

• Company car or car allowance.
• Health benefits including Medical, Dental, and Vision.
• Company match 401k.
• 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.

Salary Range

$95,000.00 - $210,900.00

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.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities at its sole discretion and with no prior notice. Equivalent experience, skills, and/or education will also be considered. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate.