Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Title: Manager, Market Access
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position Summary:
The purpose of this role is to increase market access for Microbiology Division's (MBD) clinical products through successful pre-market licenses, renewals, and strategic market analysis. This involves capturing vital regulatory intelligence, conducting market evaluations, and crafting submissions based on product technical data. The key interfaces for this position include the Global Regulatory Affairs team, Marketing, Sales, and Thermo Fisher regional RA shared services.
Responsibilities:
* Market Access and Licensing: Acquire pre-market licenses, handle renewals, and manage license changes globally.
* Market Analysis: Conduct market analysis and develop strategies to improve market access.
* Partner Engagement: Engage with healthcare providers and regulatory authorities.
* Economic Evaluation: Perform economic evaluations and health technology assessments.
* Develop and report important metrics regarding licensing activities.
* Acquire and communicate actionable regulatory intelligence globally.
* Cross-Functional Coordination: Collaborate with Product RA on QMS updates and market access strategies.
Minimum Qualifications:
* Bachelor's/Master's Degree, diploma, or equivalent combination of qualifications in life science, engineering, legal, or related fields.
* Validated experience with international regulatory affairs within the medical device or IVD industry.
Skills:
* Excellent communication and presentation skills at all organizational levels.
* Expertise in multinational regulatory strategy, risk-benefit analysis, and collaboration with internal and external stakeholders.
* Strong project management skills.
* Ability to develop and engage in a high-performance team dedicated to accountability.
* Capability to lead, influence, and innovate within a cross-functional environment.
Preferred Qualifications:
* Previous Thermo Fisher experience in Regulatory function
* RAC accreditation
At Thermo Fisher Scientific Inc., we are committed to fostering an inclusive and diverse workplace. We are an equal opportunity employer and value the strengths and perspectives that each individual brings to our team. We strive to provide reasonable accommodations and adjustments to applicants and employees with disabilities to ensure equal access to employment opportunities. If you require any accommodations or adjustments during the application process or throughout your employment, please let us know.
Join our exceptional team and take the next step in your career as an executive assistant at Thermo Fisher Scientific Inc. Apply now and seize this remarkable opportunity to contribute to our mission of enabling our customers to make the world healthier, cleaner, and safer.