Sr Manager, Medical Affairs
Há 15 horas
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 role at Vantive** **What you'll be doing** Actively leads and participates in a broad range of Medical Affairs activities including (but not limited to): - ** Evidence generation**: medical oversight of the company’s investigator-sponsored trial program, review of Medical Affairs local and global studies. - ** External engagement**: Led a team of medical managers and MSLs; reviewed materials for various departments within Vantive (publication team, Market Access, governmental advocacy group, medical information group, marketing, and Sales training); leadership and/or support of Advisory boards. Help to build scientific support for our products and therapies. - ** Scientific Exchange**: leadership of therapies educational programs; leadership and/or support of Advisory boards. Help to build scientific support for our products and therapies. - ** Patient safety**: Ensure that all information related to safety is directional to pharmacovigilance or quality. Take care of medical information inquiries. - Lead the development, implementation, and delivery of a Medical Affairs clinical and education strategy. Increase awareness and interest in our therapies within the medical community and enhance Vantive's image. Continuously develop and maintain a "state of the art" level of knowledge in this therapeutic area. - Participate and/or facilitate development, data presentation, and discussion at regional and national advisory boards, investigator meetings/events, as well as contribute to and review content development for these meetings. - Strengthen relationships and develop new relationships with Subject matter experts (SME). - Work with the marketing department to assist in their understanding of the therapy, assist in therapy campaigns and product launches, as well as be involved in new product development. Review promotional materials for scientific and medical accuracy. - Participate in the Investigator Initiative Research (IIR) program, including assisting in defining IIR strategic priorities, providing medical oversight for developing and reviewing IIR protocols and budgets, and ensuring a compliant IIR process. In addition, the IIR lead will leverage Medical Affairs field personnel to help communicate the goals of the program to health care professionals every year. Collaborate with investigators on Vantive-sponsored studies when appropriate. - Participate in HEOR (health-Economics Outcomes Research) studies and search for local unmeet needs related to this topic. - Contribute to and provide medical reviews of scientific publications and Market access publications (including, but not limited to, abstracts, posters, oral presentations, manuscripts and review articles). - Provide medical support to the Medical Information department including, but not limited to, review of standard response and custom response letters as required. - Provide support to the Governmental Advocacy department as needed. - Assist the Medical Affairs Training department with education and training for the Medical Affairs field force and in-house personnel, as needed. - Collaborate with clinical research and commercial colleagues to ensure consistency in product lifecycle management across departments. - Continuously develop knowledge of regulatory, pharmacovigilance, and quality assurance requirements in alignment with Vantive Global Business Practice Standards. - Ensure compliance with all business policies and legal guidelines. - Lead LAS Med affairs team (Medical Managers and MSLs). **What you'll bring** - MD degree. Specialization in Nephrology. - Minimum of five years of industry (pharmaceutical or medical device) experience. Previous Industry experience/ MA (Medical Managers and/or MSLs) team’s leadership. - Excellent leadership capabilities; teamwork oriented; interested in working in a multicultural and cross-functional environment; - Strong management skills; decisive; resourceful; - Well-developed interpersonal skills; strong in providi
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