J&J Family of Companies Associate Medical Director in Titusville, New Jersey
At the Janssen Pharmaceutical Companies of Johnson & Johnson, as with all of Johnson & Johnson, we hold ourselves accountable to our company Credo, crafted in 1943. This Credo is our moral compass to ensure all we do aligns with our primary responsibility to the patients, healthcare professionals and caregivers we serve, in addition to the employees, our communities and our shareholders. We are working to create a world without disease and bring together the best minds to pursue the most promising science. We encourage you to consider joining our team of passionate leaders. Learn more at www.janssen.com and follow us @JanssenGlobal.
The Associate Medical Director, Neuroscience will be responsible for medical and scientific strategy and execution of US Neuroscience (NS) projects, including safety related activities for REMS (Risk Evaluation & Mitigation Strategy) programs. Given the combination of clinical and operational elements, this role will require a solid understanding of US clinical and prescribing practices, the US healthcare environment, related regulations and pharmaceutical product distribution.
This employee will have opportunity to lead and participate in data generation and analysis to support the safety and efficacy of novel therapeutics for the treatment of mood disorders, as well as being the primary representative for REMS-related activities on the NS Risk Management Team. Responsibilities will include developing scientific strategy, conducting post-hoc exploratory analysis and communication planning while working efficiently within cross-functional teams. This individual will also partner with internal and external experts to review promotional copy, support medical information services and develop and review regulatory documents for FDA submission. As primary representative for REMS-related activities, this employee will develop, enhance, and execute internal policies, processes/procedures, and tools for REMS implementation, including REMS compliance, audit plans and FDA inspections and assure operational integration of other regulated activities interdependent on REMS including aligning communication strategy and training of internal team members.
Developing leadership skills is an ongoing priority at Janssen and this role will include the ability to guide, mentor, and coach team members, as needed to ensure people development.
Key Working Relationships:
Internal - Medical Affairs, Medical Information, Safety, Marketing, Marketing Solutions, Commercial distribution operations, Home office leadership including people managers and Therapeutic Area Leaders, other TA and JSA training, learning and development leaders.
External - Vendor oversight and interactions with federal agencies (e.g. FDA, DEA)
Decision Making Authority:
Making hiring recommendations
Recommends budget amounts
MD, DO, Physician Assistant, Advanced practice nurse (e.g. APRN) or the equivalent clinical practitioner degree (e.g. physician assistant, clinical psychologist) required
5+ years professional experience in clinical practice, industry or academia, at least 2 of which must be in the pharmaceutical industry
Mental health training and clinical experience required
3+ years clinical/ safety or equivalent experience strongly preferred
1+ years Risk Management and FDA REMS related activities preferred
General knowledge of product distribution & safety related DEA & FDA regulations
Experience in project management preferred
Must be local to Titusville, NJ
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.
United States-New Jersey-Titusville-
Janssen Scientific Affairs, LLC (6120)
J&J Family of Companies
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