17 Apr
Program Manager - Labeling - Only W2 No C2C
California, Sanjose , 95101 Sanjose USA

Vacancy expired!

Overview:Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished

Program Manager - Labeling.

Candidate must be authorized to work in USA without requiring sponsorship

Location: San Jose, CA 95131

Duration: 12+ months with possibility of extension

Note:
  • Position will be remote during COVID and onsite once offices are back open.

Summary: The Labeling Program Manager is responsible for managing the creation, approval, implementation, and maintenance of technical information for products manufactured by applicable client 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 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 client worldwide.

Requirements
  • 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 labeling 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.

3 Must-haves on the resume: Program management, Medical Device Labeling, at least a bachelor’s degree

Qualifications:
  • BS or BA degree in a technical, scientific, packaging, writing or related discipline.
  • A 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.

I'd love to talk to you if you think this position is right up your alley and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Sam Banga

Lead Recruiter

925-297-6480

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward. Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.

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