Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred
About The Position
Syneos Health is a leading fully-integrated life sciences services organization focused on accelerating customer success. The Clinical Solutions team members operate with a drug development mindset, leveraging their expertise to understand customer needs and shape solutions. This role involves collaborating with passionate problem solvers to achieve customer goals, emphasizing agility and a drive to deliver for colleagues, customers, and patients. The company is committed to developing its people through career progression, training, and recognition, and fostering an inclusive culture where employees can be authentic. The purpose, 'Driven to Deliver,' reflects the colleagues' passion for shaping solutions that significantly impact lives. Syneos Health aims to build a company that is desirable to work for and to work with, believing that by bringing together diverse talent, they can shape the future of healthcare and advance patient progress.
Requirements
- Bachelor's degree required.
- 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.
- Proficient in MS Word.
- Experience with an electronic document management system and templates is required.
Nice To Haves
- Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- Knowledge of therapeutic areas in all phases of clinical development desired.
Responsibilities
- 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, 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 process(es) needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), 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.
Benefits
- company car or car allowance
- Health benefits to include 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
