Johnson & Johnson Vision Care is recruiting for a Manager, Global Copy Clearance to be located in Jacksonville, FL.
Johnson & Johnson Vision Care (“JJVC”) specializes in disposable contact lenses, which it markets under ACUVUE® Brand Contact Lenses. Ever since the ACUVUE® Brand transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUE® lenses are worn by more people than any other brand.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager, Global Copy Clearance has the accountability for the administration of processes & standards that ensures compliant promotional communication. This individual will lead the Copy Approval process for Vision Care with a continual improvement mindset, ensuring adherence to consistent standards, guidelines, practices and procedures. The Manager, Global Copy Clearance will partner with key stakeholders across the Vision Care campus to ensure an effective, efficient and compliant user experience. S/he will develop and maintain strong partnership with commercial and reviewer stakeholders to support planning and prioritization of activities while creating copy approval submission strategies. This individual is responsible for adhering to all applicable legal and regulatory requirements, Company Health Care Compliance policies as well as to environmental policy and procedures.
The Manager, Global Copy Clearance will:
• Ensure an effective, efficient and compliant submission process (e.g. prioritization of business critical submissions, pre-alignment facilitation, pre-submission verification, meeting agenda creation, moderation of meetings, follow-ups post meetings, closed-loop verification of changes and on-going partnership with cross-functional reviewers)
• Drive Reviewer & Submitter effectiveness and efficiency gains (e.g. triaging/approving copy prior to copy team review as needed, managing/resolving conflicting reviewer comments)
• Update Standard Operating Procedures, Standards Guidelines and Claims Matrices (Claims Cataloguing) to facilitate efficient, compliant copy review process (e.g collating best practices/guidelines during copy review meetings and disseminating to stakeholders)
• Generate and disseminate metrics to provide key insights and to implement process improvements
• Develop and deliver targeted training for all new processes and material content related to compliant promotional communication to ensure all key stakeholders are trained with a focus on continuous improvement. This includes the training of all commercial associates, reviewers and key agency partners on the Copy Approval SOP, Standards Guidelines and Claims Substantiation Requirements
• Manage expiring items including archival & retirement of non-compliant promotional materials to ensure compliance with Copy Approval process
• Support all local internal/external compliance audits & non-conformance activities such as audit observations/actions & CAPA actions & effectiveness monitoring within the quality systems Maintain current regulatory and product knowledge to ensure quality decision making within Copy Approval Performs other related duties as assigned by management Qualifications
A minimum of a Bachelor’s Degree is required
• Regulatory Affairs Experience and/or a Juris Doctorate (JD) with Legal Regulatory Experience is required
• A minimum of 8 years of professional work experience is required
• A minimum of 2 years of experience in a regulated industry is required
• Experience in a commercial role is preferred
• Demonstrated knowledge in Legal and Health Care Compliance policies around Promotional Materials is preferred
• Strong interpersonal and collaboration skills within a matrixed organization is required
• Strong computer skills a must (i.e. Excel, Access, Word, PowerPoint & other technologies) is required
• Problem solving/resolution and Cross functional influencing skills is required
• Experience leading by example and driving success strategically and tactically is required
• Knowledge of process and compliance audits with internal quality teams as well as external governing Regulatory bodies such as the FDA is preferred
• Experience in Copy Approval is preferred
• Experience creating and delivering training to diverse user groups is preferred
• People management experience is preferred
• Awareness of process excellence methodology (i.e. Six Sigma, etc.) is preferred
• Involvement in and knowledge of business transformations is preferred
• Experience with audit and CAPA action plans via internal quality systems is preferred
• This position will be located in Jacksonville, FL and will require up to 10% domestic and international travelPrimary Location
Johnson & Johnson Vision Care, Inc. (6094)Job Function
Medical Science LiaisonRequisition ID