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Regulatory Medical Writer
2 months ago
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Job SummaryWe are seeking a highly skilled Regulatory Medical Writer to join our team. As a Regulatory Medical Writer, you will be responsible for developing and managing medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects, as necessary.
- Act as lead for assigned writing projects.
- 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 clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, integrated summary reports, NDA and (e)CTD submissions, investigator brochures, and clinical journal manuscripts.
- Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
- Serve as peer reviewer on internal review team providing review comments on draft and final documents.
- Adhere to established regulatory standards, including ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
- Perform on-line clinical literature searches, as applicable.
- Maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
- Maintain awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
- Complete required administrative tasks within the specified timeframes.
- Perform other work-related duties as assigned. Minimal travel may be required (less than 25%).
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) 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 and ensure 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.
At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time.
The annual base salary for this position ranges from $60,930 to $115,100. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
