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DRA Product Labeling Manager, Therapeutic Area
Boehringer Ingelheim is currently seeking a talented and innovative DRA Product Labeling Manager, Therapeutic Area to join our DRA Product Labeling department located at our Ridgefield, CT facility. As a Manager within the DRA Product Labeling Group you will, with minimal assistance from Associate Director as needed, manage coordination of activities of labeling matters for assigned BIPI marketed products, including chairing PLRT (Product Label Review Team) meetings associated with the Annual Labeling Review, CorporateCCDS compliance, and labeling activities initiated by BIPI or FDA. Also serve as back-up with some supervision to Associate Director for other products; support late-stage development labeling for NCEs/NBEs and labeling supplements initiated by BI, in conjunction with the assigned DRA product manager in the DRA Product Groups; serve as primary back-up to Associate Director in coordination of labeling matters for BIPI marketed products, including Annual Labeling Review, CorporateCCDS compliance, and labeling activities initiated by BIPI or FDA; serve as back-up to Operational Manager for coordination of labeling matters pertaining to interactions with Graphics Departments for BIPI labeling art review and approval for marketed products; liaise with FDA as appropriate and with minimal managerial supervision to achieve timely labeling reviews and approvals. As an employee, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.Duties and Responsibilities:
With minimal assistance from Associate Director as needed, chair the meetings of the Product Label Review Teams (PLRT) for assigned marketed product and provide functional support for discussions such as the Annual Labeling Review,Company's Company Core Data Sheet (CCDS) Updates, and other ad hoc issues as they occur (e.g. FDA requests for labeling changes). Ensure that each marketed products labeling is in line with the Company Core Data Sheet (CCDS) in a manner consistent with the local health authority's regulations and guidelines. Assure timely availability of preparatory documentation before the meetings, identification of issues for discussion, and prepare meeting minutes following the meeting, as well as follow up on outstanding issues for complete resolution. Also, provides functional support to and serves as back-up to Associate Director.
Interact with International Labeleing Office before major US labeling changes to ensure consistency with company core labeling, or the need for a revision of the core labeling.
Bring PLRT proposals to Product Labeling Committee (PLC) for discussion, review and approval as required.
Labeling Submissions to FDA - Coordinate preparation of regulatory labeling submissions initiated by the DRA Product Labeling Group with contributing functions in other departments. Review submissions for completeness, consistency and accuracy of proposed changes and supportive documentation, making recommendations or suggestions back to the PLRTs or DRA Product Managers as appropriate; back-up to Associate Director as regulatory sign-off authority. Acts as liaison with FDA as appropriate to achieve timely labeling reviews/approvals. Review labeling section of NDA Annual Reports. Assist product manager in the DRA Product Groups with development of labeling and primary launch materials for NCEs/NBEs.
* Demonstrate proficient and consistently evolving labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting regulations and guidance, particularly in the area of product labeling. Review regulatory developments with DRA Product Labeling Group and keep BI abreast of changes in the US regulatory environment impacting product labeling. Assist in training of DRA departmental staff and individuals from other departments in the area of labeling generation and review. Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions.
Required Education & Experience:
* Minimum B.S./B.A. degree with 5 years pharmaceutical experience in DRA or scientific discipline, with 2 years labeling experience. Desired Experience, Skills and Abilities:
* Experience drafting and reviewing product labeling (Package Inserts)and compiling supportive documentation, and demonstrate competence in marketed product labeling maintenance.
* Capable of reviewing regulatory implications of non-clinical and clinical data to evaluate the regulatory implications for product labeling with substantial support and supervision.
* Basic knowledge of US regulatory labeling requirements.
* Detail-oriented, well organized and good planning skills.
* Excellent proofreading/editing skills are required
* Excellent communication (verbal, writing, and presentation) skills necessary for interacting with upper management labeling committies andproduction/packaging facilities; good understanding of production planning processes regarding the supply and use of labeling components Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V
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