About the role

Project management of the development and localization of client’s final packaging and labeling deliverables.

Key Responsibilities

• Manage client’s labeling projects by effectively planning, executing, and collaborating with cross-functional teams to ensure that project timelines are met.
• Understand the labeling function’s role in the end-to-end project timeline and work with program management to integrate labeling timelines into the overall project timelines.
• Represent the labeling function on project kick-offs, status, reviews, meetings, and escalation of issues.
• Effectively capture meeting summaries, decisions, action items, and communicate to stakeholders.
• Create Labeling Strategy Plan for new product introductions and/or design changes.
• Create and track all project related tasks in various project management tools, such as Confluence, SmartSheet, and Asana. This includes creating diligent timelines and considering cross-functional dependencies.
• Identify project roadblocks or scope creep and communicate to cross-functional team members.
• Utilize client’s quality management system (Master Control) to route change request and packets for updates to labeling, specifications, components, and other quality documents, as needed.
• Effectively communicate urgency of approvals needed from cross-functional teams and upper management to meet project deadlines.
• Provide thorough document/process reviews to ensure accuracy and compliance. This may include creating redline of changes, comparing documents utilizing a compare software tool (Beyond Compare, TVT), or visual quality reviews.
• Manage labeling content review cycle and approvals to accomplish labeling verification.
• Responsible for the final quality of the deliverables, communicate quality issues and process deviations/risks to management.
• Collaborate with supply chain on timing of labeling updates, to reduce scrap costs, and align on printed labeling ordering strategy.
• Work in partnership with regulatory, quality, user experience, document control, human factors, product development, and operation team to meet project deliverables and timelines.
• Collaborate with language service provider to accomplish translation of English source files, as needed.
• Build a strong working relationship with client, ensuring needs are met and trust is established.
• Recognize areas of improvement and execute labeling process improvement initiatives.

Requirements

• Bachelor’s or Associate degree in a related field, or equivalent experience
• Minimum 3 to 5 years relevant medical device or pharmaceutical labelling and project management experience
• Minimum 3 to 5 years working in a Quality Management System
• Ability to develop project plans and schedules, track that team is making deadlines
• Experience working with Language Services Providers or hands on experience with localized/foreign languages
• Endurance and tenacity to work on complex, detailed projects through completion, strategic thinker

Benefits

Acolad offers a comprehensive benefits package. New employees are eligible to receive benefits on the first day of the month after their start date. Highlights of the program include:

❤️Medical, Dental, Vision, Life Insurance, Short-Term Disability, Health Savings and Flexible Spending Account options.

❤️Many other voluntary options to choose from: Voluntary Life Insurance, Long-Term Disability, Buy-Up Short-Term Disability, Identity Theft, Legal Insurance and Critical Illness Insurance.

❤️401(k) plan with 50% match on 12% employee contribution - providing an employer contribution of up to 6%.

In addition to the benefits package, Acolad also offers the following time off:

❤️Starting with 15 days of paid time off annually, with ability to move to 28 days within five years of tenure.

❤️Nine paid holidays per year.

Salary base range for this position is between $70K to $80K, dependent upon experience and physical location. This position is eligible for variable compensation in addition to the base salary.