Job Description

Updated: Yesterday
Location: India-Asia Pacific - IND-Home-Based, India
Job ID: 23006673

Description

JOB SUMMARY

Serves as a senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory while serving as primary technical contact with the internal team and the client.

JOB RESPONSIBILITIES

• 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.

\xc2\xb7 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.

\xc2\xb7 Performs on-line clinical literature searches, as applicable.

\xc2\xb7 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.

\xc2\xb7 Completes required administrated tasks within the specified timeframes.

\xc2\xb7 Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

\xc2\xb7 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.

\xc2\xb7 Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

\xc2\xb7 Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.

\xc2\xb7 Strong proficiency in Word, Excel, PowerPoint, email, and Internet.

\xc2\xb7 Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

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