Content Risk Reviewer Jobs in Hopatcong, NJ (NOW HIRING)

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.

•  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

Preferred Knowledge, Skills and Abilities

• 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.

The base salary for this position is a minimum of $130,000 and a maximum of $150,000, plus an annual bonus of 15%

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

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. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.