Senior Medical Writer

2 weeks ago

Pune, Maharashtra, India Syneos Health Full time
Job Description

Role & responsibilities:

- Minimum 5 years of experience in Project Management.
- 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.

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