Medical Writer II – MLR Reviewer, Veeva

🕒 May 22

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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. • Develops or supports a variety of documents that include, but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations. • 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, including but not limited to Journal/congress specific 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. • Familiarity with figure-creation and data visualization software, including tools such as GraphPad Prism and Adobe Illustrator, for developing high-quality scientific figures and graphics. • Familiarity with publication planning software e.g. Datavision and PubConnect (VeevaVault Promomats) • Reviews deliverables for scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets. • 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%).

🎯 Requirements

• 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. • Develops or supports a variety of documents that include, but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations. • 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, including but not limited to Journal/congress specific 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. • Familiarity with figure-creation and data visualization software, including tools such as GraphPad Prism and Adobe Illustrator, for developing high-quality scientific figures and graphics. • Familiarity with publication planning software e.g. Datavision and PubConnect (VeevaVault Promomats) • Reviews deliverables for scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets. • 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%).

🏖️ Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself.