Medical Writing Team Lead
hace 23 horas
We are seeking a skilled Medical Writing Team Lead to oversee complex projects and mentor less experienced medical writers at Syneos Health, Inc.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects, as necessary.
- Represent the Medical Writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding a writing project.
- Advise clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
- Develop good working relationships with internal and external colleagues.
- Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Develop or support a variety of documents, including but not limited to: clinical study protocols and clinical protocol amendments; clinical study reports; patient narratives; clinical development plans; IND submissions and annual reports; integrated summary reports; NDA and (e)CTD submissions; investigator brochures; clinical journal manuscripts, clinical journal abstracts, and client presentations.
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Serve as a peer reviewer, providing review comments to give maximum clarity of meaning, accuracy relevance, and to ensure that client objectives are met and overall quality standards are maintained.
- Adhere to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget.
The ideal candidate will have strong leadership skills, excellent communication and interpersonal skills, and the ability to work independently in a fast-paced environment. Additionally, the candidate should have experience in medical writing, a strong understanding of regulatory requirements, and proficiency in MS Office.
CompensationThe estimated salary range for this position is $120,000 - $150,000 per year, based on location and level of experience.
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