Global Pharmaceutical Labeling Manager – Contract position in Irvine CA
Our client needs a Contractor to work as Manager of Global Pharmaceutical Labeling. Contract is estimated for 12 months at their facility in Irvine, CA. Possibility for conversion to full-time after a year. We offer benefits including employer contribution to healthcare for this position. You must have authorization to work in the United States (sponsorship is not available).
Requirements – Must Have!
- Bachelor’s degree in a related scientific discipline with a minimum of 4 years related experience within a pharmaceutical company, CRO or similar organization.
- Or Masters, PharmD or PhD with minimum of 2 years’ experience.
- Experience drafting and reviewing pharmaceutical labeling and compiling supportive documentation, and demonstrated competence in marketed product labeling maintenance.
- Live within commuting distance to Irvine, CA
- Basic knowledge of global core data sheet guidance and US regulatory labeling requirements. Relevant experience may include a background in Drug Regulatory Affairs (i.e., FDA liaison) with experience in interpretation of FDA regulations, including exposure to labeling development and maintenance, or a background in medical writing with exposure to FDA regulations as a guide in content development for medical and/or regulatory documentation.
- Detail-oriented, well organized and good planning skills.
- Ability to manage multiple projects and deadlines.
- Ability to exercise independent judgment yet identify compliance risks and escalate whennecessary.
- Excellent proofreading/editing skills are required
- Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.
- Excellent computer skills required
Main Areas of Responsibilities
- Facilitate Core Pharmaceutical Labeling Review Committee and US Labeling Review Committee meetings for assigned marketed or development product, ensuring the timely distribution of preparatory documentation, identification of issues for discussion, preparation of meeting minutes and follow-up of action items to complete resolution. Provide strategic Labeling guidance to authors regarding appropriate content for Company Core Data Sheets, FDA regulations, and FDA guidance.
- Assist in the development and review of international local labeling in accordance with the Company Core Data Sheet
- Interact with business partners and provide strategic guidance as appropriate to ensure consistency and compliance of product labeling.
- Manage outside vendor conversion of package inserts from MS Word or PDF to SPL format. Convert existing package inserts into Physician Labeling Rule (PLR) format, as needed.
- Coordinate preparation of regulatory labeling submissions initiated by Regulatory Affairs with contributing functions in other departments.
- Review for completeness, consistency and accuracy of proposed changes and supportive documentation, making recommendations or suggestions back to the Project Teams or Regulatory Strategists as appropriate.
- Demonstrate proficient and current labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting evolving FDA regulations and guidance.
- Assist with training of Regulatory Affairs and other functions re: labeling processes as appropriate.
- Maintain knowledge of applicable corporate/company SOPs, guidelines, and working instructions related to product labeling.
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