Medical Device Labeling & Documentation Manager

Vereinigte Staaten, Indiana, Indianapolis

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Job Summary                                                                                  

Assist the Director or senior leadership in overall operations of assigned department(s).  Contributes and achieves results through the management of subordinates (professional and support staff).  Establishes and manages the department's budget and all assigned resources.  Provides leadership to ensure department objectives and goals are achieved.  Directs and implements tactical plans.  Has full discretion on all employment decisions for department staff including hiring, training, performance management, and progressive disciplinary actions.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Key Roles & Responsibilities

  • Provides leadership for, manages and develops the US Product Information Operations staff consisting of Technical Writers and Labeling Specialists:
    Ensures all training, development needs, and performance appraisal requirements are identified and addressed within set time frames. Responsible for succession planning within current area of responsibility, establishing a course of action for self and others to accomplish specific goals. Ensures training records are maintained for all individuals working in area of responsibility. Responsible for establishing priorities to achieve divisional objectives within set time frames. Ensures that required departmental AWIs are developed, written and maintained to be in compliance with the divisional quality objectives.

  • Primary U.S. focal point and global representative for the development and implementation of product labeling for the CPS division. Develops and implements strategies for creating primary packaging, product labeling and documentation required to support new product launches, global initiatives, country specific configurations and other divisional initiatives:
    Implements conceptual development to the final deliverable for product labeling (e.g., Method Sheets, Application Sheets, Addendums, Labels, Value Sheets, Barcode Transfer Sheets, TAS files, e-packages and CDs) and other electronic documentation as requested by Regulatory Affairs, Marketing, Quality and other stakeholders. Responsible for final local approval of product labeling documentation.

  • Routinely interacts with CPS Product Information Operations counterparts to negotiate, develop and maintain agreed upon global labeling strategies for all CPS products: Participates as the US representative with CPS counterparts on global teams to design and implement processes and software required for creating and maintaining product labeling. Interacts and negotiates with various global departments to resolve issues related to labeling development. Develops strategies for successful implementation of global projects within agreed time frames.

  • Participates on global projects while coordinating correlated actions:
    Provides direction to project teams, and project managers during project startup regarding US labeling and budget requirements, timelines and other US labeling deliverables. Negotiates solutions between management, core functions, CPS counterparts, divisional functional areas and external suppliers concerning issues/problems with product labeling, ensuring all US FDA, CLSI, Quality System, ISO, Branding, IVDD and divisional requirements are met. Establishes processes for maintaining consistency of information across documentation. Develops, maintains, and achieves departmental budget.

  • Ensures that all training requirements for the Quality Policy are met by US Product Information Operations staff:
    Establishes appropriate management controls to satisfy regulatory requirements and the company's quality policy and objectives. Performs the quality planning to drive continuous improvements and changes of the RD quality system to ensure ongoing effectiveness and efficiency. Develops and drives a work culture committed to compliance, quality and customer focus. Identifies and implements new departmental processes to ensure that the output of the department meets all RD Quality standards. Actively insures that all labeling updates are completed within the assigned time frame to prevent customer complaints, CAPAs, and past due tasks.

  • Effectively evaluates and re-allocates workload of US Product Information Operations staff to ensure that the department's deliverables can be completed within required timeframe:
    Develops strategies for obtaining and/or reallocating the resources required to meet divisional objectives. 

Minimum Qualifications

  • Bachelor’s degree in business or technical discipline such as science or engineering or equivalent education or experience.

  • 5 years progressively responsible manufacturing or operations leadership experience.

  • Knowledge of quality systems.

Preferred Experience

  • Knowledge of CPS (Centralised and Point of Care Solutions)
    products.

  • Knowledge of FDA regulations.

  • Pharma &/or Diagnostic industry experience highly preferred.

  • Experience creating medical device &/or pharmaceutical labeling and method sheets highly preferred.

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Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.