Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.
Post : Regulatory Compliance Monitoring Lead Analyst, Medical Devices
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Job Description
• Conduct monitoring of FDA regulatory promotional practice laws, regulations, policies and guidelines.
• Develop a robust monitoring work plan for the medical device businesses based on risk assessment.
• Execute monitoring plan with a focus on appropriate promotion including third party collaborations, acquisitions, new business models, products with novel technologies, field-based staff, advisory boards, professional education, copy approval, etc.
• Work with Health Care Compliance Officers and Regulatory Affairs to lead the effort to identify and execute monitoring solutions for areas identified during the risk assessment process.
• Monitor the compliance effectiveness of the Regulatory Affairs process harmonization initiatives to ensure alignment to the medical device businesses and the J&J enterprise-wide regulatory function.
• Cultivate collaborative relationships with HCCOs and business partners, providing recommendations and guidance to address risk remediation plans from monitoring results.
• Develop executive summary metrics and dashboards customized to each business unit using data analytics tools.
• Partner with and support global medical device centers of excellence monitoring initiatives.
• Contribute to project teams that support the overall global HCCP organization.
• Responsibility may include the supervision of a contractor(s).
Candidate Profile
• A minimum of a Bachelor’s Degree is required.
• A minimum of six (6) years of regulatory experience required.
• Experience working in a Pharmaceutical, Biologics or Medical Device industry is required.
• Experience working with databases, data analytics and data visualization tools is preferred.
• This position requires a highly-motivated individual with strong analytical skills, intellectual curiosity and proven leadership skills.
• Strong communication, presentation, interpersonal, negotiating and influencing skills is required.
• Proven track record of taking risks and a demonstrated self-starter is required.
• Demonstrated forward thinking and continuous improvement mindset is required.
• Ability to multi-task and manage conflicting priorities independently is required.
• Must be able to travel up to 15%-20% of the time, mainly to domestic destinations with potential for international, depending on business need.
Additional Information:
Location: United States-New Jersey-Somerville
Education: Bachelor’s Degree
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Health Care Compliance
Job Code: 2951171018
End Date: 19th January, 2018
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