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Vantive
Vantive

Regulatory Agency Communications Lead

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  • US
    Deerfield, Illinois, United States
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À propos

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.Your RoleResponsible for the written communications between Vantive and regulatory agencies in response to questions or requests within the Vantive quality management system. Responsible for following and (as needed) adjusting the regulatory agency communications process, globally and company-wide. Responsible for tracking and trending all regulatory agency requests.What You'll be doingResponsible for the coordination, filing and tracking of all regulatory agency inquiries and responses for VantiveUses technical writing expertise to draft and finalize regulatory agency responsesProvides support and ensures regulatory agency responses and inspection response status updates are accurate, complete, on-point, and submitted on-timeCoordinates and leads team meetings with Subject Matter Experts (SME’s) and stakeholders to drive responses for inquiries from regulatory agenciesMaintains a high level of expertise in current regulatory requirements, and serves as a resource for compliance to these requirementsInteracts frequently with leaders, SME’s, and functional technical expertsWhat You'll Bring Bachelor degree required, Master degree preferred5+ years of experienceProven Technical WriterMust be able to take information (technical, product specific, scenario based, etc.) from SME’s and summarize for responsesExcellent interpersonal skills; must have excellent written and oral communication, influencing/negation skills to maintain effective and trusting relationships with internal/external customersGood project management and organization skillsThorough knowledge of procedures, regulations and standards (e.g. FDA Regulations, Good Laboratory Practices, Good Manufacturing Practices, etc.)Experience interacting with regulatory agencies such as US FDA, EU notified bodies, Health Canada, etc.Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.We understand compensation is an important factor as you consider the next step in your career. At Vantive, 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 $88,000-132,000 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. This position may also be eligible for discretionary bonuses, and/or long-term incentive. 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.US Benefits at VantiveThis is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future.  The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently.  The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | VantiveEqual Employment OpportunityVantive is an equal opportunity employer. Vantive 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.                                                                                                                                                               Know Your Rights: Workplace Discrimination is IllegalReasonable AccommodationVantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form LinkRecruitment Fraud NoticeVantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Compétences idéales

  • Project Management
  • Technical Writing
  • Deerfield, Illinois, United States

Expérience professionnelle

  • Copywriter
  • Legal
  • General Project Management

Compétences linguistiques

  • English
Avis pour les utilisateurs

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