Sr. Medical Affairs Specialist

Sr. Medical Affairs Specialist

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients' digital visions.

Apex has an opportunity for a Sr. Medical Affairs Specialist. For applicants who are interested in this opportunity, send your updated resume to

Position:
Sr. Medical Affairs Specialist

Location:

Acton, MA

Project Duration: 6 months

Rate:
Negotiable Bases on Experience

3 days/week on site in Acton, MA

Reporting to the Senior Manager of Medical Affairs, Global Medical Communications, the Sr. Medical Affairs Specialist position will leverage clinical and disease state expertise to inform numerous initiatives to communicate the clinical value of our client's medical device scientific data. This dynamic role will work collaboratively with Clinical and Commercial cross-functional teams to influence corporate strategy and inform the use of our client's line of products to improve the lives of people with diabetes.

The ideal candidate has in-depth knowledge and experience in diabetes and diabetes technologies (e.g., insulin pumps, continuous glucose monitor systems) and has experience interpreting business issues and solving complex problems related to the critical appraisal and dissemination of clinical data according to local regulations. A detailed-oriented and proactive individual with strong scientific acumen, problem-solving skills, and a collaborative spirit will excel in this position.

Responsibilities

• Responsible for the development and delivery of medical responses to healthcare providers' off-label inquiries on a global scale; requiring knowledge of local regulations and customs, translations, and expansive line of products.
• Responsible for reviewing the content of global clinical promotional materials to ensure they are medically and scientifically accurate, meet compliance standards, and adhere to all applicable regional regulations and industry guidelines on a global scale.
• Strategize and inform the development of evidence generation plans to provide meaningful data and impact innovation, support expansion of claims and indications, and satisfy regulatory requirements.
• Coordinate the implementation of data management systems with external vendors to ensure compliance standards are met and functionality is optimized.
• Develop and execute data dissemination plans to effectively communicate the clinical value of the line of products to both internal and external audiences, including healthcare providers, people with diabetes, investors, and regulatory bodies, to emphasize the value of the line of products and inform clinical care.
• Analyze evidence related to diabetes therapies, standards of care, and technologies to inform product development and commercial and regulatory strategies.
• Collaborate with Clinical and Regulatory Affairs on the development of clinical summaries for regional regulatory submissions on a global scale.
• Develop clinical quality standards by ensuring procedures reflect current practices and initiatives align with set standards on a global scale.
• Strategize and execute plans for International, National, and local scientific conferences (e.g. presentations, reports, medical information booth).
• Provide mentorship to Medical Affairs interns.

Key Decision Rights

• Responsible for collaborating with cross-functional teams to ensure the clinical value of the our client's diabetes medical device line of products is communicated internally and externally in a manner that is scientifically accurate, solves unmet needs, and meets global regulatory requirements.
• Responsible for interpreting business issues and recommending best practices to ensure the efficient delivery of global off-label information to healthcare providers via the Medical Information channel.

Required Leadership/Interpersonal Skills & Behaviors

• Proven leadership skills through the development and management of projects with a cross-functional team.
• Works independently, with minimal guidance.
• Strong collaborative and cross-cultural skills to work cooperatively between several internal and external teams globally. Creative with a…