Senior Medical Science Manager

Senior Medical Science Manager

Terumo Europe

Belgium

Job Summary

Meeting the growing need for scientific evidence in the regulatory space, a new Medical Sciences team has been formed. To lead this new team of 4 associates, we are looking for a Senior Medical Sciences Manager. Your key mission would be generating medical component of key regulatory documents, provide medical insight into the regulatory strategy and ensuring safety oversight of clinical trials.

Job Responsibilities

Medical support to Regulatory

  • You will work closely with the Regulatory Affairs EMEA team, who operates out of the HQ in Leuven, Belgium. You will generate key documents such as CEP, CER, Literature review protocols, literature review reports. You will provide medical insight and expertise to Regulatory teams and they can lean on you and your team’s expertise to review risk and benefits of TERUMO devices.

Leadership

  • You identify and communicate the actions needed to implement the strategy and business plan within your department. You explain the relationship of your team objectives to the broader organization's mission, vision and values and you motivate them to doing extraordinary things to achieve their objectives and thus reaching business goals;
  • You coach, manage and report on the performance of the team. You set the right performance objectives for your 3 direct reports and follow up on their performance for achieving these. You take appropriate action where necessary to ensure the achievement of these team and personal (development) objectives. You show care for their personal growth.

Stakeholder Management

  • You participate in relevant focus groups, task forces and other scientific and professional organizations, like MedTech-Clinical/Digital, to stay up to date with the latest developments in the medical field, explore new specific therapeutic areas, and give input to the R&D group that is linked to our production plant in Leuven and to the CMO;
  • You act as an interface with regulatory agencies on clinical aspect of the regulatory approval of the products (includes discussions, communications, and negotiations with Regulatory authorities in preparation for CE Mark, PMDA, FDA);
  • Furthermore, you establish and maintain a professional and credible image with key physicians, consultants, vendors, and co-workers and act as the company clinical and medical expert in the cardiovascular area.

Safety

  • In addition, your team is responsible for Safety Reporting across studies by overseeing safety data and supporting the communication related to the safety issues with investigators and regulatory bodies;
  • Oversees review of AEs, SAE, medical assessment and instruct staff in appropriate handling and follow up activities.

Profile Description

  • You are an MD., Pharmacist, Vet D, PhD or equivalent degree with work experience in Interventional Cardiology or Peripheral interventions. You can look back at a minimum of 7 years’ experience in the medical device industry. In Previous roles, you have built a strong track record in writing CERs and CEPs and in Regulatory Affairs in general. In addition, you have a thorough knowledge of relevant guidelines documents (ISO, ICH GCP..) and its applicability to all stages of the clinical development process. You have a good understanding of the device development process and experience in overseeing global clinical trials;
  • As a leader of a team, you have a proven experience in people management in a multicultural environment. You love motivating and inspiring others, bringing out the best out of your team and the people you are working with. Thanks to your planning skills, you know how to forecast budgets and manage them accordingly;
  • You have excellent written and oral communication skills, including strong formal presentation skills, in English and one other European language. Your strong interpersonal skills commensurate with the need to effectively manage teams of peers and to work closely with both external physicians/scientists and numerous in-house support groups. You maintain the highest degree of confidentiality and integrity, represent the company’s high ethics, moral behaviour, and professionalism;
  • You keep your scientific credibility while being commercially supportive. You communicate scientific results and effectively respond to data queries from customers and/or consultants;
  • As a person, you are a problem solver, and analytical thinker and can self-direct easily. You are flexible to travel 10% of your time within EMEA.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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