Sr Mgr FDA Business Excellence 

     

About the job

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
 

Senior Manager FDA Business Excellence

 

This FDA Business Excellence position is responsible to ensure Bayer Pharmaceuticals is focused on FDA as a customer working closely with Policy and US Regulatory colleagues to monitor, communicate and train on FDA activities and relevant information pertaining to new or modified standards, regulations and FDA processes.  Additionally, this role aids in the development, compilation, and communication of FDA best practices and ensures Bayer’s positions/actions are consistent with FDA.

 

Our Tasks And Responsibilities

 

 

Focused on FDA as a customer and how Bayer plans and interacts with this customer, including developing and managing the One stop shop “FDA & Bayer”. Participates in special projects, to further the US Regulatory Affairs department’s knowledge of FDA.Manages Bayer information/operational databases (e.g., US Regulatory Affairs SharePoints, the RPI toolkit).Aids in the development/compilation/and communication of FDA data and Bayer positions including statistics, best practices, and general information.  Performs regulatory research requests, as needed and partners to develop case studies of FDA and competitor actions and ensures learnings are discussed internally.Monitors upcoming FDA policy changes, summarizes changes (as needed), including the identification of changes requiring Bayer process revisions. Develops best practices and processes surrounding FDA interactions, submissions, and compliance.Partners to aid in the implementation of FDA changes (e.g., PDUFAs) including information dissemination and training.Monitors FDA external activities (conferences, speaking engagements etc.) and organizes Bayer’s participation and internal content dissemination. Monitors external vendor AI/ML/automation surrounding Regulatory Intelligence, manages vendor contracts internal training and actively looks for new reg intelligence opportunities.Manages US commenting process and leads the development of Bayer comment letters. Partners to develop and utilize automated tools for FDA commenting and tracks commenting effectiveness.Oversees Freedom of Information (FOI) requests.

 

 

Who You Are

 

Bayer seeks an incumbent who possesses the following:

Qualifications & Competencies

 

Education:  Post-secondary degree in computer science, communication, life science or equivalent field required.Regulatory experience within the pharmaceutical industry and preferably at the US Food and Drug Administration.Ability to work collaboratively without authority.Knowledge of the US regulatory affairs environment, regulations, operating procedures, policies and guidance.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/outcomesKnowledge of the drug/device development process.Project management skills, including attention to detail.Strong ability to communicate in both oral and written English, communication and/or training background an asset.Digital, AI or Machine Learning expertise an asset.

 

This posting will be available for application until at least ​7-29-2024​. 

 

Employees can expect to be paid a salary between $​​.  Additional compensation may include a bonus or commission (if relevant).   

Other benefits include health care, vision, dental, retirement, PTO, sick leave, etc. If selected for this role, the offer may vary based on market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors. 

#LI-US 

#LI-REMOTE 

  YOUR APPLICATION   

Do you want to work in a place where you can be just YOU?

Your unique personality, background and talents help build a strong, diverse and inclusive Bayer. 

So join us! Be You, Be Bayer.
 

 Location:

United States : New Jersey : Whippany || United States : District of Columbia : Washington  

 

Division:

Pharmaceuticals 

 

Reference Code:

821097