Job Description

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is recruiting for a Director, Medical Operations Clinical Evaluation, to be located at any J&J; Medical Device Facility in the US (Somerville, NJ or West Chester, PA preferred); or potential to be located Globally in Europe (Germany, UK, Switzerland); Or remote options may be considered.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

The Director, Medical Operations Clinical Evaluation, will provide strategic oversight and governance ensuring high standards of compliance in Medical Operations functions charged with delivery of key regulatory and medical documents. You will lead a diverse Med Ops team based in multiple geographies and ensure the identification and retention of high potential individuals through active engagement, motivation, development, and promotion. You will provide leadership and maintain relationships through extensive interdependent partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. This role will also support the Med Ops lead for the EU MDR project establishing the strategy surrounding CERs and SSCPs.

KEY RESPONSIBILITIES:

* Lead a team of medically proficient scientists across Ethicon to compile and analyze product related safety and performance data, draft reports and coordinate approval of Medical Affairs-generated Regulatory documents.
* Be responsible for the effective optimization and harmonization of CER and SSCP processes within HMD while aligning with the J&J; Enterprise guidelines and regulatory requirements.
* Ensure the CER and SSCP processes are linked to appropriate Quality Systems and Regulatory Processes to ensure information is accessible where needed and will develop, implement and be responsible for an effective communication model for CERs/SSCPs within Ethicon.
* Provide management leadership to their staff to provide direction and to support the professional development of direct reports.
* Develop and supervise compliance metrics for CER & SSCPs across HMD, providing visibility of issues and enable corrective and preventive action to be taken as needed.
* Design, develop and lead workshops to define compliant processes globally and stays on top of regulatory requirements and industry trends / practices.
* Track and trend NB questions and observations across HMD to inspire changes to improve the Medical Operations compliance posture.
* Accountable to support the development and management of the Medical Operations budget pertaining to CERs/SSCPs for the Ethicon business
* Act as the Medical Operations liaison with respective Notified Bodies and regulatory agencies regarding CERs and SSCPs helping to craft JNJ HMD strategies and building critical relationships.

Qualifications
* A minimum of a Bachelors Degree is required
* A focused degree in Life Sciences, Engineering or related subject area is highly preferred
* An advanced degree, MBA, PhD or MD is highly preferred
* A minimum 10 or more years of related experience (ie. In a regulated environment) is required
* A minimum 3 or more years people/interpersonal leadership experience within a sophisticated matrixed environment is required
* Experience in a highly compliant environment is required
* Proven knowledge and experience in quality, regulatory and healthcare compliance is required
* Demonstrated experience or ability to build relationships/stakeholder management across a multi-business or matrix environment is required
* Experience in change management is also required
* Ability to collaborate on a global level is required
* Excellent communicator, can manage and lead change is required
* Ability to influence and provide a leadership presence across the matrixed organization is also required
* Experience in Medical Device is highly preferred.
* Previous Clinical experience and knowledge of clinical trial design, evidence generation, adverse event reporting and surgical practices/principles is highly preferred
* Previous budgetary responsibility is preferred
* Project Management/Six Sigma certifications highly preferred
* Ability to translate insights into viable process and solutions that create value in Medical Operations is highly preferred

* This position can be performed remotely. However, the ability to work onsite at times at Somerville, NJ for business needs is preferred.
* This position requires approximately 25% Domestic and International Travel

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.

Primary Location
United States-Pennsylvania-West Chester-1302 Wrights Lane East
Other Locations
United Kingdom, United States-New Jersey-Somerville, , Switzerland, United States, Germany
Organization
Medical Device Business Services, Inc (6029)
Job Function
R&D;
Requisition ID
2005879902W