Medical Affairs Manager - NJ

Getinge•Wayne, NJ

13d•$130,000 - $150,000•Hybrid

About The Position

The Medical Affairs Manager serves as a clinical and scientific expert relevant to their assigned product 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.

Requirements

Bachelor’s Degree in the Science Field Required, with a minimum of 8 years of relevant experience, OR, an Advanced Scientific Degree with a minimum of 5 years of relevant experience
Must be familiar with the appropriate medical and/or surgical environment and current treatment options or have relative clinical 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
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 developing and maintaining professional relationships with healthcare experts for educational, collaborative, and/or research purposes
Experience with cross-functional teams, promoting collaboration and quality results across global business functions
Strong verbal, written, and presentation skills
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
Effective problem-solving capabilities, solution oriented with the ability to understand, review, and communicate complex technical concepts concisely and accurately
Promotes 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
Proficiency with Microsoft Office Suite

Nice To Haves

Experience working with a variety of stakeholders across multiple disciplines on medical communications, educational content, deliverables
Experience writing and implementation of standard operating procedures
Solid understanding of FDA and Global Regulatory Authority policies regarding medical device companies
Medical writing experience.

Responsibilities

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. 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 on cross-functional teams. This may include strategic projects related to product development, risk management, clinical evaluation, clinical marketing, product marketing, and business development.
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.
Provide detailed medical assessments related to routine and ad-hoc review of complaints, serving as the voice of the customer & patient 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.