Labeling Program Manager (Must have Medical Device Labeling)

Millenniumsoft•San Jose, CA

1d•Hybrid

About The Position

The Labeling Program Manager is responsible for managing the creation, approval, implementation, and maintenance of technical information for products manufactured by applicable BDB sites. This includes developing and maintaining content and graphic standards as proposed by corporate, regulatory, safety, legal and global guidelines. The Program Manager serves as a champion of best practices and continuous improvement and participates, and also leads business and corporate-wide initiatives. The Program Manager is accountable for the development and execution of strategies and plans to meet key operational goals. This leadership role is responsible for positive customer experiences as it relates to the global product information. Error in this information could result in a significant budgetary impact as well as regulatory risk and subsequent action against BD worldwide.

Requirements

Program management experience
Medical Device Labeling experience
At least a Bachelors Degree
BS or BA degree in a technical, scientific, packaging, writing or related discipline.
Minimum of 5 years of experience in packaging or labeling is required.
Desktop Publishing application experience (Adobe Creative Suite and/or MadCap Flare).
Experience working on international cross-functional teams.
Working knowledge of US and international medical device regulations.
Demonstrated ability to influence others (beyond direct reports).
Demonstrated ability to effectively handle multiple project priorities.
Excellent organization & prioritization skills.
Excellent follow-up and documentation skills.

Responsibilities

Develops, revises, and reviews product package labelling, carton labels, and component labels to ensure compliance to global regulations.
Analyzes product specifications and oversees development of documentation which may include instrument/software manuals, reagent package inserts, and labels for sustaining products.
Ensures accuracy, clarity, appropriateness, and consistency of documents; reviews and may evaluate documents of other writers when appropriate.
Serves as a resource to writers and label designers in areas of content development and label design.
Follows logical, structured, and consistent thought processes when planning, speaking, and presenting in meetings.
Possesses ability to organize information into a clear and logical sequence.
Performs gap analysis and make suggestions for improvements to processes and procedures.
Manages workload, timeline and resources for a project. Informs team early about possible issues. Plans and prepare for possible issues and formulates a mitigation plan.
Has the ability to craft and deliver explanations that anticipate customers’ questions and solve customers’ problems.
Serves as a subject matter expert for product labels/inserts and/or instrument and software user's manuals.
Works with R&D, Marketing, Quality, Medical, Regulatory, Supply Chain and plant teams and associates to develop/revise product labelling, user documentation and determine specifications for: type style, font size, clarity and conformity of wording, formatting and print/digital delivery.
Assists with the development and implementation of packaging and labelling processes for BDB plants.
Works with Label Control, Incoming Inspection, Operations and Quality to resolve quality issues regarding labelling, and developing internal and external procedures geared toward minimizing and eliminating labelling recalls.
Develops, reviews and maintains vendor specifications, graphic and labelling standards.
Develops procedures and policies to streamline the labelling design/development process.
Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business units and plant projects to meet established goals.
Keep abreast of and comply with the basic requirements for compliance in own area of work. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.