Sr. Principal Regulatory Medical Writer - Oncology

Sr. Principal Regulatory Medical Writer - Oncology Preferred

Key Responsibilities:

• 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 communication 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.

Benefits:

• Company car or car allowance.
• Health benefits to include 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 (eligibility may vary depending on location).

Salary Range: $95,000.00 - $

EEO Statement:
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. It will fulfil all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive. 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.