Senior Manager Switch Science
Your tasks and responsibilities
The primary responsibilities of this role, Senior Manager Switch Science, are to:
- Identify and anticipate potential obstacles for assigned switch product(s) and ensure comprehensive issues management plan is in place to address strategic hurdles to achieve regulatory approval and commercial success;
- Participate in the development of the Drug Facts label, developing and implementing appropriate switch development plan, developing overall switch strategy and incorporating this strategy into FDA Briefing documents as well as the NDA.
- Coordinate strategic efforts to plan, manage and implement a successful FDA Advisory Committee meeting;
- Develop clinical plans related to all drug studies, including but not limited to Actual Use studies, retrospective chart analyses, analysis of existing clinical studies and all specialized studies required for each individual Rx-to-OTC Switch;
- Identify all potential issues related to switch, and determine appropriate outside stakeholders. Research key opinion leaders (KOLs) and establish a board for consultation and input into the switch;
- Maintain current knowledge of trends in the over-the-counter (OTC) industry, focusing on identifying and evaluating potential switch candidates outside of Bayer;
- Assist with the internal review, analysis and approval process for opportunities, as well as providing input for value and financial impact of alternatives, for all external candidates.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor's Degree;
- Five years of experience in OTC pharmaceuticals;
- Must have a strong working knowledge of all elements of clinical research;
- Strong strategic thinking ("big picture" vision) with proven analytical capabilities;
- Needs to have well-rounded business experience with strong general management skills;
- Requires a broad skill set/capability across a variety of functional areas including clinical research, behavioral science, regulatory, and medical;
- Well organized;
- Able to readily coordinate and direct complex projects toward defined goals;
- Capable of interacting with senior management with sufficient experience to understand and discuss complex business issues;
- Able to quickly define problems and issues;
- Collaborative leadership style, ability to manage large, complex projects with ability to gain alignment across multiple stakeholders with potentially diverging set of interests;
- Precise and concise communication skills and able to work across diverse cultures;
- Proven networking and partnering skills;
- High energy level and hands-on.
- Master's Degree;
- Experience in all aspects of Rx-to-OTC switch;
- Strong understanding of regulatory requirements, authoring NDAs and experience working with healthcare authorities, particularly the FDA.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. 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.
Country: United States