Vacancy for Medical Writer at Syneos Health

Syneos Health™ is an end-to-end, fully integrated biopharmaceutical solutions company that works differently. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together to create customer success. Our unique Biopharmaceutical Acceleration Model delivers value across the small to mid-size to large customer continuum.

Post : Medical Writer I

Job Description
Job Summary
Serves as medical writer on clinical study or regulatory project teams. Assists in writing, editing, and coordinating content for clinical/regulatory documents with dependent staff roles to ensure satisfactory completion of all writing projects.

Responsibilities
• Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision.
• Develops or supports, a variety of documents that include but not limited to:
- Clinical study protocols and clinical study protocol amendments;
- Clinical study reports;
- Patient narratives;
- Investigator brochures.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Adheres to established regulatory standards, including but not limited to 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.
• Performs on-line clinical literature searches, as applicable.
• Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
• Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Candidate Profile
• 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 with a familiarity with AMA style guide.
• Understanding of FDA and ICH regulations and guidelines strongly preferred.
• Demonstrated effective presentation, proofreading, and interpersonal, 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.

Additional Information
Qualification : B.Sc
Location : Hyderabad-Madhapur-Village
Industry Type : Pharma/ Healthcare/ Clinical research
Req Id : 20001742
End Date : 28th February, 2020