Medical Affairs Manager - NJ

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

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

Job Overview

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.

Job Responsibilities and Essential Duties

* 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.

* 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.

* 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.

Required Knowledge,

Skills and Abilities

* 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…