at Baxter Healthcare Corporation in Deerfield, Illinois, United States
Job Description
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Your role at Baxter
Responsible and accountable for leading the design and development of global Regulatory processes & systems related to regulatory intelligence. Candidate will be responsible for all operational aspects of the Regulatory Intelligence program, including implementation of process and continuous improvement.
What you'll be doing
Act as RA Intelligence Team Lead responsible for the following:
Analyze status quo (review existing procedures / vendors, and identify unmet representation needs in standardization committees)
Customize and tailor future state process, including process design, vendor selection, and SOP development and deployment
Establish appropriate communication within RA and with other functions primarily at project level and favor proactive communication
May represent Baxter interests in industry and working groups
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
Identify & prioritize key areas of risk, and develop & implement appropriate mitigation plans
Develop and implement role-based regulatory plans aligned with business needs
Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement
Develop and document sound regulatory decisions and justification.
Communicate with regulatory authorities
Establish appropriate communication within RA and with other functions primarily at project level and favor proactive communication
Lead role-based activities
Represent or lead the RA function on assigned cross-functional project teams
May provide direct supervision of individuals
What you'll bring
Bachelor's degree or country equivalent in a scientific field
Masters and/or PhD will be an advantage.
Minimum of 5-year regulatory experience in RA or related field, including people management or projects.
Scientific knowledge
Ability to multitask and prioritize
Ability to work effectively in multinational/multicultural environment
Sound basis of Regulatory knowledge
Management skills
Ability to manage complex projects and timelines in a matrix team environment
Strong interpersonal, communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Technical and management skills
Ability to lead and coach others
Ability to independently identify compliance risks and escalate when necessary
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000-$143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or... For full info follow application link.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
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Pay Transparency Policy
