Senior Medical Writer (Project Mgt exp)
- Company
Syneos Health
- Location
Pune, MH, India
- Employment Type
Full-Time
-
Functional Category
Research & Knowledge Management
-
Experience
5 - 6 years
- Date Posted
15-Sep-2025
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.
- Website
Overview of the Role
The role involves leading and managing medical writing projects, mentoring junior writers, and producing high-quality clinical and regulatory documents. Responsibilities include cross-functional coordination, document review, SOP and guideline creation, and ensuring compliance with industry and client standards. Proficiency in Microsoft Office (especially MS Visio), strong communication skills, and experience in team handling are essential. The role also includes literature reviews, process mapping, and budget adherence, with minimal travel required.
Job Description
• Must possess excellent communication skills and should be proficient in Microsoft Office.
Should have prior experience in team handling.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc., and serves as a medical writer within and across departments with minimal supervision.
• Ability to create process maps from provided technical material or from client inputs. Hands on experience of using MS Visio or similar tools.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• 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 providing review comments on draft and final documents.
• Adheres to established regulatory standards 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.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness 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%).
Required & Preferred Qualifications
Experience
Minimum 5 years of experience in Project Management.