Sr Associate, North America Label Change Project Coordinator
Sr Associate, North America Label Change Project Coordinator
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Job Description
Hello. Were Haleon. A new world-leading consumer health company. Shaped by all who join us. Together were improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum through a unique combination of deep human understanding and trusted science. Whats more were achieving it in a company that were in control an environment that were co-creating. And a culture thats uniquely ours. Care to join us. It isnt a question.
About the Role
The Sr Associate North America Label Change Project Coordinator is responsible for coordination of US and Canada labeling activities and artwork brief preparation including serving as a key point of contact for cross-functional teams and the Global Artwork Center of Excellence (COE).
Role Responsibilities
This Regulatory Affairs Operations & Compliance role is responsible for labelling activities of assigned brands including:
Artwork US and Canada
Coordination of artwork brief preparation
Support the business by representing the artwork process on project team meetings and through tracking labeling timelines
Initiation of artwork changes in Artwork Management System (CHAMPS)
Collection of market sources in CHAMPS (regulatory sources design claims)
Verification that final artwork aligns with sources provided
Provide annotations to Artwork COE for urgent health authority requests
Support audits and inspections
Regulatory Content Documents (RCDs) - US
Performing independent review in document management system (Veeva RIM Vault) including general proofreading for spelling and grammar and compliance with local regulatory requirements
Websites US
Coordination of updates for labelling and safety content for US websites including:
Triaging reviews and approvals with Medical and Regulatory Strategists
Providing new or revised labeling
Assisting with special requests including audit and inspection support
Assisting in reviewing content and verifying accuracy as needed
Structured Product Labelling (SPL) US
Performing independent review of SPLs using electronic proofing tools
General
Manage priorities and timelines to ensure timely delivery according to process and project timelines
Responsible for up to 3 categories/brands totaling about 500 changes responsible per year attributing to 500000 (GBP) in revenues
Prioritize and escalate when necessary
Resolve conflicts ensure data integrity
Assist with research or other assignments to support Operations and Compliance activities in the US/PR
Actively participate and share ideas with the team for best practices process improvements and enhanced efficiencies
Contribute to the wellbeing of Haleon through positive teamwork and cross-functional partnerships
Why you
Basic Qualifications:
Bachelors Degree
Minimum 3 years of experience in a labeling-related role (e.g. pharma or OTC CPG artwork labeling project management etc)
Experience working on cross-functional teams
Experience with cGMPs
Preferred Qualifications:
Advanced degree in project management business quality or scientific disciplines; RAC
Experience working on global teams
Project management experience
Experience in document management including Veeva and/or an artwork management system
SAP
Knowledge of US regulations: CFR and labeling guidance documents
Location: This role is based in Warren NJ. This role has in-office requirements of minimum 3 days per week.
Please save a copy of the job description as this may be helpful to refer to once the advert closes.
Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan tuition reimbursement and time off programs including 6 months paid parental leave. On day one you are eligible for benefits including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering. The salary range for this role is: $84076 to $115604 plus a 8% bonus.
As you apply we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer and in the US we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color national origin religion sex pregnancy marital status sexual orientation gender identity/expression age disability genetic information military service covered/protected veteran status or any other federal state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license Haleon may be required to capture and report expenses Haleon incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleons compliance to all federal and state US Transparency requirements.
Accommodation Requests
If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process please contact us by sending an email to Please include the following in your email:
Use subject line: Haleon Careers: Job Accommodation Request
Your Name and contact information
Requisition ID and Job Title you are interested in
Location of Requisition (city/state or province/country)
Description of specific accommodation you are requesting
Resumes CVs or other requests outside of accommodation support submitted to this email box will not be accepted.
Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan tuition reimbursement and time off programs including 6 months paid parental leave. On day one you are eligible for benefits including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.
Required Experience:
Senior IC
Employment Type
Full-Time
