This is a high level contract role, requiring Direct Global Regulatory Labeling Operations Project Management experience in the Pharma/Biotech industry, as deep knowledge of pharmaceutical labeling regulations, compliance, and processes are critical for this role.
The Labeling Project Manager is responsible for all activities associated with the development, creation and execution of labeling for assigned product lines for domestic and/or international markets. This position interacts with internal functional groups (e.g., Packaging Development, Quality, Inventory and Planning, and Regulatory Affairs) and third-party suppliers (print vendors, drug product packagers). The Labeling Project Manager is the Labeling Operations representative on project teams during the development and approval process of commercial product labeling.
- Less than 10% travel required
- Day trips to local third-party vendors (up to 3 hour drive)
- Occasional domestic flights & overnight stays may be required
location: Telecommute
job type: Contract
salary: $150.00 - 165.90 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Maintains overall responsibility for all creation, revision and maintenance of labeling materials (i.e., artwork and ancillary specification documentation) associated with marketed pharmaceutical products through interactions with advertising agencies, external graphics design studios, print vendors Global Regulatory Labeling, regional artwork suppliers and international functions as applicable.
- Participates as Labeling lead on cross-functional project teams
- Ensures the control of company printed copy through the approval and distribution of controlled label artwork proofs, printed item specifications, implementation instructions to print vendors and contract packagers.
- Ensures technical accuracy and production readiness for all labeling materials associated with assigned product lines
- Provides back-up/overflow support for Labeling team projects
- Modifies style guidelines for new labeling initiatives due to business model changes or emerging regulatory changes.
- Identifies efficiency and continuous improvement opportunities.
- Creates, revises and approves GMP compliant SOPs to align with new and established policies and procedures.
- Oversees vendor performance through management of labeling change projects, product launches, and by attending supplier audits and occasional site visits
- Oversee and direct proofreading activities in support of labeling projects.
qualifications:
- Bachelors degree or 10 years relevant labeling and/or graphics experience
- Minimum of 5 years experience in pharmaceutical label development
- Strong knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Labeling.
- Strong knowledge of print manufacturing processes and printing graphics techniques
- Strong knowledge of packaging process and operations
- Less than 10% travel required
- Day trips to local third-party vendors requiring drives of up to 3 hours
- Occasional domestic flights and overnight stays may be required
skills: FDA, Vendor Management, Regulatory Affairs Operations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
