Medical Writer II – MLR Reviewer, Veeva

This is a fully remote position, open to applicants in United States.

📋 Description

• Provides mentorship and guidance to junior medical writers on intricate projects, as needed.

• Takes the lead on designated writing assignments.

• Oversees medical writing tasks related to individual studies, coordinating activities across various departments with minimal oversight.

• Creates or assists in the development of various documents, including but not limited to: clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations.

• Recognizes and suggests solutions to challenges and inquiries that arise during the writing process, including appropriate resolution or escalation.

• Evaluates statistical analysis plans and table/figure/listing specifications for content accuracy, grammar, formatting, and consistency.

• Collaborates with department heads and team members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to generate writing deliverables.

• Functions as a peer reviewer on the internal review team, providing feedback on draft and final documents.

• Complies with established regulatory standards, including but not limited to journal/congress-specific guidelines, as well as company standard operating procedures, client requirements, and company or client-approved templates, ensuring timely and budget-compliant medical writing projects.

• Conducts online clinical literature searches, as applicable.

• Possesses knowledge of figure creation and data visualization software, such as GraphPad Prism and Adobe Illustrator, for creating high-quality scientific figures and graphics.

• Familiarity with publication planning software, e.g., Datavision and PubConnect (VeevaVault Promomats).

• Reviews deliverables for scientific precision, data quality, referencing accuracy, appropriate style, and correct branding of scientific/medical assets.

• Stays updated on current industry practices and regulatory requirements and guidelines impacting medical writing.

• Maintains awareness of budget constraints for assigned projects, adhering to budgeted hours and communicating any changes to medical writing leadership.

• Completes necessary administrative tasks within designated timeframes.

• Performs additional work-related duties as assigned.

• May require minimal travel (less than 25%).

⛳️ Requirements

• Provides mentorship and guidance to junior medical writers on intricate projects, as needed.

• Takes the lead on designated writing assignments.

• Oversees medical writing tasks related to individual studies, coordinating activities across various departments with minimal oversight.

• Creates or assists in the development of various documents, including but not limited to: clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations.

• Recognizes and suggests solutions to challenges and inquiries that arise during the writing process, including appropriate resolution or escalation.

• Evaluates statistical analysis plans and table/figure/listing specifications for content accuracy, grammar, formatting, and consistency.

• Collaborates with department heads and team members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to generate writing deliverables.

• Functions as a peer reviewer on the internal review team, providing feedback on draft and final documents.

• Complies with established regulatory standards, including but not limited to journal/congress-specific guidelines, as well as company standard operating procedures, client requirements, and company or client-approved templates, ensuring timely and budget-compliant medical writing projects.

• Conducts online clinical literature searches, as applicable.

• Possesses knowledge of figure creation and data visualization software, such as GraphPad Prism and Adobe Illustrator, for creating high-quality scientific figures and graphics.

• Familiarity with publication planning software, e.g., Datavision and PubConnect (VeevaVault Promomats).

• Reviews deliverables for scientific precision, data quality, referencing accuracy, appropriate style, and correct branding of scientific/medical assets.

• Stays updated on current industry practices and regulatory requirements and guidelines impacting medical writing.

• Maintains awareness of budget constraints for assigned projects, adhering to budgeted hours and communicating any changes to medical writing leadership.

• Completes necessary administrative tasks within designated timeframes.

• Performs additional work-related duties as assigned.

• May require minimal travel (less than 25%).

🏝️ Benefits

• We are passionate about nurturing our workforce through career development and advancement; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive rewards program.

• We are dedicated to fostering an inclusive culture where you can genuinely express yourself.