Description
Syneos Health is seeking a Medical Writer II (CSR Narrative) to join their team.
The successful candidate will have a minimum of 2-4 years of medical writing experience and 1 year of narrative writing experience, with a focus on CSR Narrative writing.
Key responsibilities include:
- Mentoring less experienced medical writers on projects as necessary
- Compiling, writing, and editing medical writing deliverables
- Developing or supporting a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and investigator brochures
- Reviewing statistical analysis plans and table/figure/listing specifications
- Interacting with department heads and staff members as necessary to produce writing deliverables
- Serving as a peer reviewer on internal review teams
- Adhering to established regulatory standards, including ICH-E3 guidelines
The ideal candidate will have:
- A Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree with relevant scientific and/or medical knowledge and expertise
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet
Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, and a total rewards program.
The company is committed to building an inclusive culture where employees can authentically be themselves.