Description
Syneos Health is seeking a Sponsor Dedicated - Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have).
As a Sr. Principal Medical Writer, you will develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and the client authoring standards. You will manage medical writing projects, participate in cross-functional meetings, and mentor more junior medical writing staff.
Responsibilities:
- Develop regulatory documents for submission to regulatory agencies globally
- 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, timelines, and any process(es) needed for the completion of regulatory documents
- Review other documents associated with the assigned project(s), as appropriate
- Participate in cross-functional process improvement initiatives
- Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents
- Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects
- Mentor more junior medical writing staff
Requirements:
- Oncology experience preferred, but not required
- Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development
- Proficiency in organizing and communicating clinical information required with minimal oversight
- Strong organizational, time management, and project management skills are required
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment
- Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired
- Proficient in MS Word. Experience with an electronic document management system and templates is required