Associate Medical Scientist

About the role

Responsible for setting work direction and completion of work tasks under supervision of the Medical and Scientific Affairs Management. Will provide input into product documents and presentations on behalf of the Medical and Scientific Affairs team who are responsible for safety of product. Interacts with internal stakeholders such as Project Core Team members, Global Clinical Development, Statisticians, Regulatory Affairs, Technical Writing, Marketing and Legal. May interact with investigators.

Responsibilities

• Provide input into product documents and presentations on behalf of the Medical and Scientific Affairs team who are responsible for safety of product.
• Interact with internal stakeholders such as Project Core Team members, Global Clinical Development, Statisticians, Regulatory Affairs, Technical Writing, Marketing and Legal.
• Interact with subject matter experts and potentially with investigators.
• Recognize existing problems, develop recommendations, and successfully implement solutions of simple or moderately complex problems.
• Experience with systematic literature search, appraisal and reporting representing Medical and Scientific Affairs (as part of team) on specific projects/programs.
• Facilitate the creation of a schedule for deliverables for the program team, then revise and update the schedule through the course of the program.
• Hands-on work habit and down-to-earth personality with ability to solve problems and mitigate issues.
• Manage project schedule, generate timelines, and deliverables under supervision.
• Carry out tasks and activities that are defined in local business/operating plans.
• Show strong training and presentation skills and intermediate project management knowledge.

Requirements

• Industry experience, understanding of product development process and leverage support from cross-functional team members.
• Excellent interpersonal and communication skills, including the ability to perform well in a highly matrixed environment, and as an effective member of a highly functioning multidisciplinary team.
• Demonstrated ability to create, organize and maintain technical/medical documentation supporting regulatory submissions, and communication of results (conferences, publications, etc.).
• Facilitates the creation of a schedule for deliverables for the program team, then revises and updates the schedule through the course of the program.
• Hands-on work habit and down-to-earth personality with ability to solve problems and mitigate issues.
• Solid knowledge of Good Clinical Practices, Regulations and Guidance, including Clinical Laboratory Standards relative to the conduct of clinical trials and evidence generation for in-vitro products.

Qualifications

• Advanced Degree, Master's or MD or PhD or other allied health or other allied health degree/certification in a health-related or life science.
• A minimum 2 years of experience in a regulated industry environment, such as in vitro device, medical device, biotech, or pharmaceutical industries.
• Previous direct experience presenting data from clinical trials experience within an IVD and/or medical device industry are highly desired.
• Previous flow cytometry experience or clinical laboratory experience are desirable.