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Syneos Health hiring Medical Writer

 

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Syneos Health hiring Medical Writer

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Post : Medical Writer II-Narratives

Job Description
•  Mentors less experienced medical writers on projects, as necessary.
•  Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal 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;
- Annual reports;
- Investigator brochures.
•  Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
•  Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
•  Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
•  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.
•  Working knowledge of drug development process and regulatory guidelines.
•  Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.
•  Stays 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 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.


Additional Information
Qualification : Bachelor of Science degree
Location : India
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th September, 2023

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