J&J Family of Companies Hiring for Associate Director, Medical Affairs at Dover, Delaware Full Time

Associate Director, Medical Affairs – 2406161306W

Description

Laminar Inc., recently acquired by Johnson & Johnson is hiring for an Associate Director, Medical Affairs. This is a fully remote role.

In this highly visible role, with limited supervision and general direction, the Associate Director, Medical Affairs is responsible for generating the clinical evidence strategy to support clinical claims. In this key customer-facing position, the Medical Affairs will liaise with key opinion leaders to increase awareness and adoption of the Laminar left atrial appendage closure procedure. The Medical Affairs will drive cross functional activities that support data dissemination and knowledge enhancement.

Job Description

• Maintaining strong knowledge of LAAC, Laminar device, and competitive landscape

• Developing, managing, and engaging with key opinion leaders and healthcare providers

• Participating in the pivotal clinical study Steering Committee meetings

• Managing and developing content for interventional cardiology and electrophysiology conferences and symposiums

• Driving the creation and distribution of physician and patient-focused literature and other materials to increase awareness and understanding of left atrial appendage closure, the Laminar LAAC System, and Laminar clinical investigations

• Generating pivotal marketing strategies to increase clinician awareness and maximize study recruitment

• Managing publication related activities

• Participates in characterizing the product’s capabilities and clinical workflows in collaboration with the clinical, R&D, and other development team members

• Partnering in the development of professional medical education materials and effective training programs for physicians and staff

• Ensuring the development and execution of product and/or procedural evidence generation and dissemination strategies

• Supporting early product introduction to the market supporting launches as well as internal & external training

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

Qualifications

Qualifications:

Required:

• A minimum of a bachelor’s degree is required

• A minimum of 8 years previous industry experience working with Medical/Clinical/R&D teams in pharmaceuticals or medical devices

• Experience with preclinical and clinical research is required.

• Proficient understanding of medical device technologies, their development process, and regulatory requirements specific to medical devices in the United States and internationally, such as ISO 13485, FDA 510(k), or PMA (Pre-Market Approval).

• Demonstrated success in medical data generation and publication.

• Strong communication and negotiation skills

• Ethical Standards: Commitment to maintaining ethical standards in clinical research, including patient privacy, informed consent, and protection of human subjects.

• Experience managing and developing external facing content for professional conferences and symposiums, patient-focused literature and other materials, professional medical education materials and effective training programs for physicians and staff

• Experience engaging with key opinion leaders and healthcare providers

Preferred :

• An advanced degree is preferred

• At least 4 years in medical affairs preferred.

• Familiarity with clinical research methodologies and practices and adherence to US and international regulatory guidelines (i.e., 21 CFR Parts 11, 50, 54, 56, 812 and ISO 14155).

• Able to interpret, summarize, and communicate complex medical literature to internal and external customers.

• Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally.

• Must be able to collaborate well with multiple partners and work effectively in a matrix environment.

• Continuous Learning: Willingness to stay updated with the latest advancements, regulations, and industry best practices in clinical research and medical device technologies.

Working Conditions:

Home-office based and includes approximately 50% travel to conferences and/or other Laminar affiliated activities. The employee is frequently required to use a computer and sit for extended periods of time in office. Must maintain a clean driver’s license. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-United States

Other Locations NA-US-California-Los Gatos

Organization Biosense Webster Inc. (6010)

Relocation Eligible: No

Travel Yes, 50 % of the Time

Job Function Medical Affairs

Req ID: 2406161306W