Medical Affairs Manager (Cardiac Assist) - Remote

Company: Getinge
Location: Wayne
Posted on: May 27, 2023

Job Description:

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.

Are you looking for an inspiring career? You just found it.

Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5 -C above pre-industrial levels.

We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

We currently have an opening for a Medical Affairs Manager. The role of the Medical Affairs Manager is to serve as a clinical and scientific expert relevant to their assigned therapy area(s), engaging with healthcare professionals (HCPs) and internal Getinge representatives. The Medical Affairs Manager is responsible for providing pertinent literature, education, and scientific expertise on product use throughout the product life cycle. This individual will provide scientific or technical guidance to related departments, participate in the development and execution of strategic projects and documentation to ensure that Getinge products are utilized safely and effectively, and may be responsible for the creation and implementation of processes and systems. This role has global work responsibilities.

Job Functions:

• Engage in scientific exchange with thought leaders and practicing HCPs in relevant therapeutic area(s) to enhance disease state education, research, development, and partnership with Getinge Medical Affairs. This includes providing clear, informative, fair-balanced, compliant, and documented responses to medical or scientific information requests from HCPs, including those related to off-label use.
• Manage internal knowledge databases and dashboards of interactions, requests for information, approved communications, and technical support records related to off-label use.
• Provide medical/technical subject matter expertise to internal and external stakeholders in accordance with current regulatory and health care compliance guidelines, ensuring accuracy of communications to support assigned therapy area(s). This includes content development for regulatory submission and/or scientific communication, and reviewing/approving technical, educational, and promotional materials as needed.
• Represent Medical Affairs for assigned therapeutic area(s) on cross-functional teams. This may include strategic projects related to product development, risk management, clinical evaluation, clinical marketing, product marketing, and business development.
• Provide medical support at scientific meetings/congresses. Attend scientific sessions and relay appropriate insights to cross-functional teams.
• Support implementation of all aspects of the Medical Affairs plan through strong cross-organizational collaboration & understanding of business needs. Ensure corporate compliance with regulatory policies governing medical education, medical communication, and other related interactions with external parties.
• Monitor and review literature, including performing systematic literature searches. Maintain current in-depth knowledge of the clinical landscape, developments, and trends to support identified product lines and therapeutic area(s).
• Provide detailed medical assessments related to routine and ad-hoc review of complaints, serving as the voice of the customer when critically evaluating adverse events.
• Combine an understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge to support global regulatory submissions. This may include participation (as an evaluator and, in some cases, leading cross-functional teams) in the clinical evaluation and/or post market clinical follow up processes and the generation of its consequent documents. Interaction with regulatory agencies may be required.
• Contribute to the development and authoring of technical documentation (SOPs, medical assessments, health hazard evaluations, etc.) for internal and external use in accordance with regulatory requirements and guidelines.
• Participate in management reviews to support, as appropriate, audit findings, root cause analysis, preventive or corrective actions, and other quality metrics.
• Participate in product risk management activities to identify clinical risks, usability hazards, data on safety and performance, adverse events, and benefit-risk profile of a device or devices, in accordance with both internal risk management processes and applicable standards. Required Knowledge, Skills and Abilities:
  • Candidate must have an advanced scientific degree with 5+ years of industry experience OR Bachelor's degree with 8+ years of previously related experience. Solidunderstanding of FDA and Global Regulatory Authority policies regarding medical device companies
    • Must be familiar with the appropriate medical and/or surgical environment and current treatment options or have relative experience that fulfills this requirement;
      • Proven understanding of the medical device industry and healthcare system requirements
      • Knowledge of regulatory requirements, compliance standards, and ethical obligations
      • Insight to determine sales and customer communication/education needs throughout a medical device/product life cycle
      • Strong verbal, written, and presentation skills to include medical writing experience. Experience writing and implementation of standard operating procedures
        • Effective problem-solving capabilities, solution oriented with the ability to understand, review, and communicate complex technical concepts concisely and accurately
        • Experience with cross-functional teams, promoting collaboration and quality results across global business functions while promoting successful teamwork and morale
        • Ability to work independently, establish functional priorities, and execute goals while managing multiple tasks simultaneously
        • Drive change, challenge the status quo and make recommendations for process improvements
        • Communicate effectively at multiple levels in a global matrix organization, as well as with HCPs, medical/research staff, healthcare educators, hospital decision makers, and payers
        • Experience working with a variety of stakeholders across multiple disciplines on medical communications, educational content, deliverables; along with experience developing and maintaining professional relationships with healthcare experts for educational, collaborative, and/or research purposes
          • Excellent time management skills, ability to work independently, self-motivated, highly accountable for deliverables and timelines
          • Detail oriented, highly organized, and performs work with a high degree of accuracy
          • Proficiency with Microsoft Office Suite About us
            
            Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise 'Passion for Life' close to heart.
            
            If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company.
            
            Benefits at Getinge:
            
            At Getinge, we offer a comprehensive benefits package, which includes:
            • Health, Dental, and Vision insurance benefits
            • 401k plan with company match
            • Paid Time Off
            • Wellness initiative & Health Assistance Resources
            • Life Insurance
            • Short and Long Term Disability Benefits
            • Health and Dependent Care Flexible Spending Accounts
            • Commuter Benefits
            • Parental and Caregiver Leave
            • Tuition Reimbursement
              
              Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

Keywords: Getinge, Wayne , Medical Affairs Manager (Cardiac Assist) - Remote, Healthcare , Wayne, New Jersey