About This Role

The Sr. Promotional Review Specialist ensures all direction from Reviewers during the Commercial Promotional Review Committee process are properly carried through in approved US Commercial communications. The Specialist will monitor adherence to Veeva standard operating procedure, drive editorial quality, and prioritize review deadlines. Provide Regulatory and editorial guidance to Project Owners and agency partners to ensure all communications provide adequate provision with approved label components, appropriate pieces are ready for FDA submission, and all promotional HCP, patient, payer, social media, internal and other communications meet the highest standards for compliance and overall quality of content. The role will partner with Reviewers (Regulatory, Legal, Medical) and other Biogen stakeholders to support business goals in a timely manner.

What You’ll Do 
•    Review PRC-approved materials in their most recent version for carry-through of Reviewer decisions, errors, clarity 
•    Within a 3-4 day window for review, set priorities for files based on pieces approved for expedited review and/or Date of First Use, Professional Print, or CRM development
•    Ensure digital pieces meet all Regulatory presentation standards (ie, use of red-boxed annotatibons, website screenshot layout, inclusion of related PRC codes) for submission to FDA
•    Maintaining accuracy and consistency within pieces and across content within a brand
•    Ensure clarity of meaning, correct grammar, spelling and use of footnotes
•    Review presentation decks for design consistency and errors, with special attention to re-purposed slides, charts, footnotes
•    Review communications for approved label components, placement of Important Safety Information and safety sprinkles, adequate provision, brand names and generic
•    Review CRM materials for the Field during cPRC review and for functionality in field-based platform
•    During label update periods, ensure uniform adoption of approved materials by agency partners and project owners  
•    Maintain communication and collaboration with Marketing team, Regulatory, and, as needed, Medical and Legal, to resolve questions and move communications forward in a timely manner 
•    Research industry best practices to compile editorial database to assist Marketing and agency partners

Who You Are 
Collaborative team player, upbeat, enthusiastic, positive and diplomatic.

Required Skills
•    3-5 years of editing experience. 
•    Detail oriented with exceptional proofreading skills
•    Familiarity with the American Medical Association Manual of Style
•    Excellent written, communication and time management skills with a strong command of the English language
•    Computer skills, knowledge of internet searches, and proficiency in Microsoft Windows software specifically Word, Excel, and PowerPoint
•    Ability to work quickly and confidently under tight deadlines
•    Bachelor’s degree required

All your information will be kept confidential according to EEO guidelines.