Location: all cities,PA, USA
Johnson & Johnson is recruiting for a Lead, Specialty Compliance Policy and Regulatory Operations within the Health Care Compliance Organization. The preferred locations for this position are Horsham, PA or Titusville, NJ as it is highly beneficial to be co-located with key business partners.
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Key Responsibilities
The Policy Lead will:
* Lead Policy Team and help identify and provide timely review and summary of policies and guidances distributed by FDA, Federal Register, OPDP, etc. (RAP Repository Responsible)
* Support the Specialty Compliance team with any FDA Register Request for Comment, potentially impacting existing J&J products, policies, or services
* Timely review of pertinent internal and external policy forums and information
* Collaborate and take lead on pertinent trainings and communications
* Supporting the Regulatory Operations team and delivering tasks and priorities impacting Regulatory Operations function (e.g. 2253 Submissions, Subpart E/H, Advisory Comments, Launches, and Line Extensions, etc.)
* Support additional regulatory compliance efforts within the organization as appropriate
* Partner with business to ensure that emerging advertising and promotion technologies and mediums are consistent with applicable laws, regulations, guidelines and company policies related to the submission of advertising and promotion materials (e.g. maintenance of high-quality and compliant submission to FDA of all promotional materials)
* Serve as an engaged member of the NA Program Management team with responsibilities for providing updates and driving consistency, engaging in strategy development, and providing oversight of projects and initiatives (SpC Project Tracker) to advance the promotional compliance framework, including partnering to embed FDA requirements into the business and being responsible for engaging in a variety of tasks and initiatives, including many that call for sound judgment and independent initiative
* General understanding to support coordination (& lead where vital) across initiatives to define a standardized methodology and approach to value creation; align organization to definitions/calculations for realization, adoption across initiatives, and analytics/reporting/metrics that reflect Specialty Compliance Organizational initiatives.
* Continually evaluate the organization's ability to deliver value on reporting and insights and create & deliver compliance value recommendations for change where applicable.
* Help to drive functional area communications strategy, including change management activities, management of outward facing portals, and establishment of Champion Networks
* Established technical writing expertise with the ability to make significant and creative contributions to overall user engagement materials including presentations, guides, portals, slide decks, etc.
* Work in collaboration with leadership to create, execute and align the strategy for roll out of new systems and tools