Medical Writer II – MLR Reviewer, Veeva

Job 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.

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