Medical Affairs Specialist
2 weeks ago
At CTI Clinical Trial and Consulting Services, we are seeking a highly skilled Medical Affairs Specialist to join our team. This exciting role will provide medical, scientific, technical, and customer-focused support to our organization.
The successful candidate will be responsible for providing expert guidance from a medical perspective to new product development, sustaining development, risk management, and regulatory processes. They will also be responsible for providing expert medical affairs knowledge to the wider cross-functional team.
As a Medical Affairs Specialist, you will have the opportunity to work with a talented team of professionals who are passionate about advancing the world of health. You will be responsible for providing input into Clinical Evaluation Reports (CER's) and Risk Benefit Analyses (RBA's) as required.
Key responsibilities of the role include:
- Representing Medical Affairs in New Product Development and Sustaining Development Core Teams, ensuring the role is represented according to our product development process.
- Collaboration and approval of documentation required according to our Quality Management System (QMS) for products under development and products in the post-market stage.
- Providing input into go-to-market models with business group and commercial teams.
- Developing scientific relationships with Key Opinion Leaders (KOL's) within the infusion area.
- Coordinating, attending and contributing to selected scientific and medical congresses and webinars.
- Participating as needed in activities related to our post-market vigilance system, including participation in the formation of Situation Analyses, Health Risk Assessments, and Incident Investigations.
- Ensuring relevant and appropriate responses to customer inquiries for relevant products.
- Directing the regular review of scientific literature in cooperation with marketing for key products.
- Continuously maintaining knowledge for the medical and commercial teams regarding developments and trends in medical practices relevant to the business.
- Maintaining up-to-date knowledge of regulatory and quality assurance requirements in alignment with our Practice Standards.
We are looking for a highly skilled and experienced Medical Affairs Specialist who has a strong background in the medical device industry, preferably gained with Alaris or CME infusion devices. The ideal candidate will have excellent English communication skills, both written and verbal, and experience in writing and reviewing technical and/or academic documentation.
The role will require frequent travel, including internationally up to 50-60% of the time. If you are a motivated and experienced Medical Affairs Specialist looking for a new challenge, please apply for this exciting opportunity.
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