23 Dec
Project Manager III
Vacancy expired!
- Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
- Work directly with Commercial teams from concept through review and approval, up to and including APLB submission.
- Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials
- Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.
- Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
- Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
- Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
- Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
- Work with other RC team members to provide input into improvement of systems and/or processes.
- Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies, etc.
- Review current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed
- This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as well as for all verbal and written communications with APLB reviewers
- The individual will require strong verbal and written communication skills; strong interpersonal skills; good listening skills; strong negotiation skills; demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions.
- At least five through seven (5-7) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
Vacancy expired!