US Labeling Manager
2 months ago
US Labeling Manager
US Labeling Manager
PURPOSE
Responsible for assigned operational processes of US labeling document creation and maintenance for all products in close collaboration with US RA and global labeling staff. Manages relevant operational processes of US packaging, creation, implementation, and maintenance, acting in close collaboration with Product Supply/Supply Chain, US RA and global labeling staff.
Oversees 3rd party contracting services related to US product packaging and labeling activities for all products.
YOUR KEY TASKS AND RESPONSIBILITIES
- Manages operational labeling processes in accordance with the US Code of Federal Regulations (CFR) and company processes for all US regulatory label documents (e.g., USPI);
- Maintains close collaboration with global labeling staff;
- Supports the development, review and approval of US labeling in close collaboration with US RA, packaging content for all products intended for US registration or market maintenance and manages actions required to implement labeling with Product Supply/Supply Chain;
- Maintains accurate documentation and records of labeling activities, including version control, change control, and approval history in Bayer’s regulatory information management system;
- Responsible for timely and clear communication regarding upcoming label changes (e.g., CCDS, CBEs, PAS, annual reportable);
- Communicates road map of expected US approvals to allow for strategic planning and discussions with affected stakeholders;
- Sends complete SPL via FDA gateway for posting on DailyMed;
- Communicates with cross-functional US working group and notifies of effective new/updated labeling in close collaboration with US AdPromo and US business to create/update US labels in alignment with business strategy;
- Responsible for compiling, maintaining, and ensuring communication of US competitor label comparisons working in close collaboration with US Regulatory Leads/Liaisons and global labeling;
- Monitors US regulatory environment for changes to US regulatory labeling requirements and guidances, and communicate any potential impact to the Bayer business and products (working with relevant US RA staff as appropriate);
- Oversees 3rd party contracting services for activities related to US product packaging and labeling for all products, interacting with CMC lead and global labeling staff as appropriate;
- Partners with Product Supply artwork staff and Change Management.
WHO YOU ARE
Bayer seeks an incumbent who processes the following:
REQUIRED QUALIFICATIONS
- Bachelors’ degree or above degree in life science or equivalent with education in a relevant health science area;
- Regulatory experience in the pharmaceutical industry;
- Expert knowledge and understanding of FDA labeling regulations and guidances, and their application to drive competitive US labeling;
- Demonstrate understanding of how labeling impacts advertising activities and business strategy.
- Ability to work collaboratively without authority;
- Continually seeks feedback from peers to improve business outcomes and able to set and deliver against 90-day and long-term goals to achieve desired impact/outcome;
- A demonstrated proactive approach, experience leading continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills;
- Ability to manage compounds with a certain degree of complexity from a labeling perspective;
- Project management skills, including attention to detail, with the ability to focus on multiple issues at one time under time pressure;
- Ability to think strategically; appropriately assess and formulate strategies to mitigate risk;
- Excellent knowledge of medical and scientific terminology and pharma manufacturing complexities.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Bayer is an E-Verify Employer. Location: United States : New Jersey : Whippany Division: Pharmaceuticals Reference Code: 821435 Contact Us Email: hrop_usa@bayer.com
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