Manager Medical Affairs
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 an Manager Medical Affairs. For applicants who are interested in this opportunity, send your updated resume to [email protected]. Here are the details: Position: Manager Medical AffairsLocation: Remote Project Duration: 10 monthsRate: Negotiable Based on ExperienceKey Accountabilities: · Provide effective medical leadership and work collaboratively within your assigned project teams to advise and guide the strategic objectives and operational decisions impacting global project direction. · Act as the medical expert, drawing on your experience and knowledge of diabetes management, established standards of care, published data and key opinion leader insights. · Shape medically sound product design requirements, critically assess systems and user error risks, and advise on risk control measures that ensure safe and effective use. · Engage closely with clinical validation teams (Clinical Affairs, Human Factors, User Experience) to formulate study needs, evaluate outcomes, and confirmation of risk control effectiveness. · Inform evidence generation strategies based on program objectives and cross functional inputs that result data needed to support regulatory approval and competitive product claims. · Translate available data into meaningful and robust insights and conclusions that support regulatory requirements, commercial claims, and product value messaging. · Gather and translate medical intelligence from key industry experts by engaging with the Medical Science Liaison team, investigators, and advisory boards. · Collaborate on medical go to market strategies and content for regional downstream teams that include professional education programs, medical conference presentations, and other healthcare provider/customer engagements. · Support assessment of professional learning needs and educational requirements that ensure safe and effective use of Omnipod and related products. Education and Experience: Minimum requirements · 5+ years in clinical, industry, or research settings that specifically relate to the diabetes disease state and devices (i.e., insulin pumps, continuous glucose monitors) or equivalent combination of education and experience. · Life science degree with 5+ years of experience with medical affairs and/or medical strategy within medical device or pharmaceutical industry or related discipline. Preferred requirements · Advanced degree and/or healthcare related certification (PA/NP, Registered Nurse, Registered Dietitian, Certified Diabetes Care and Education Specialist, PharmD). Skills and Competencies: · Proven experience in Medical Affairs including developing and leading the implementation of medical strategy. · In-depth understanding of diabetes (type 1 and type 2) including disease pathophysiology, treatment options, risks, and outcomes · Advanced knowledge of diabetes technology including automated insulin delivery systems. · Experience with designing research studies and interpreting data. · Skilled in medical communication to diverse audience groups. · Passion for working within a cross-functional team environment. · Strong technical and business acumen. · A clear understanding of the US and global regulatory environment related to medical devices. · Able to thrive in a fast-paced, multitasking environment and effectively prioritize project timelines. · Self-driven and regularly meets or exceeds expectations. · Working knowledge of relevant software programs [e.g., Microsoft Office Suite, Adobe Products, Medical Communication tools (Medical Information CRM, Promotional Material Review), etc.)] · High ethical standards which apply to interactions with HCPs, payers, and industry representatives Physical Requirements (if applicable): · Location: Hybrid or remote position. Travel within North America and internationally will be required, up to 15% of the time depending on location Apply tot his job Apply To this Job