Andrea Howard Email & Phone Number

Waltham, Ma

Waltham, Ma

Waltham, Ma

Cambridge, Ma

Boston, Ma

Provide regulatory support (both technical and operational) in the area of product labeling for approved products and those under review, interacting cross-functionally with members of commercial, legal, safety, medical groups; Update and maintain labeling documents throughout product lifecycle, including core labels, package inserts, product packaging, and for the tracking and archiving of these documents within electronic data management system; Work closely with print vendors, translation vendors, and third party manufacturers to maintain control over those processes from a regulatory perspective

• Provided a range of editorial services, with main responsibility for document support to communications review committee (CRC), from submission through final approval, printing, and archiving of all company marketing collateral; verified accuracy of all submitted materials and worked with agencies on appropriate preparation and referencing of documents for OPDP submission• Captured and reconciled regulatory, legal, and medical comments in review meetings within electronic document management system; document review oversight to ensure that all content met regulatory, legal, medical, and commercial requirements outlined in meetings• Wrote and implemented editorial style guide that was used by all marketing agencies and internal stakeholders• Responsible for final approval of all printer proofs of marketing collateral

Belmont, Ma

Copy edited and proofread print and online materials for pharmaceutical sales training agency; Developed and implemented client-specific style guides; Advised medical writers and project managers regarding adherence to varied client requirements; Managed online content for major client

Bachelor Of Arts (B.A.), Art History

Education record