Medical Writer Lead
hace 2 semanas
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model puts the customer and patient at the center of everything we do, simplifying and streamlining our work to make Syneos Health easier to work with and for.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects.
- Act as lead for assigned writing projects, managing medical writing activities and coordinating with departments.
- Develop and support various documents, including clinical study protocols, reports, and submissions.
- Identify and propose solutions to resolve issues and questions arising during the writing process.
- Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
- Interact with department heads and staff members to produce writing deliverables.
- Serve as a peer reviewer on internal review teams, providing review comments on draft and final documents.
- Adhere to established regulatory standards, including ICH-E3 guidelines and Company Standard Operating Procedures.
- Maintain familiarity with current industry practices and regulatory requirements and guidelines.
- Work within budgeted hours and communicate changes to medical writing leadership.
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines, as well as a familiarity with AMA style guide.
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills, ensuring a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
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Medical Writer Lead
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