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

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

The Sr. Principal Medical Writer will develop regulatory documents for global regulatory agencies, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews. The role involves managing medical writing projects, coordinating timelines, participating in cross‑functional meetings, reviewing related documents, and requires eCTD submission experience.

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH, global guidelines, standards and processes, and Incyte authoring standards, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines 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 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:
  
  Medical, Dental, 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.

$95,000.00 – $

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract. 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.