Global Labeling Manager
Woodcliff Lake, NJ
Now hiring for a hungry Global Labeling Manager who has a generous spirit, is committed to creating change and is committed to the pharmaceutical industry. The Global Labeling Manager position is located in Woodcliff Lake, New Jersey, and will facilitate and lead the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) and Country Product Information (CPI) and CPI components for assigned products.
- Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects
- Provide tactical and strategic guidance to International and Regional Project Teams regarding regulatory requirements, content and design for TPP, CCDS, CPI and CPI components for assigned products
- Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements
- Coordinate Content of Drug & Establishment Listing SPL generation and review
- Ensure appropriate tracking of labeling projects
- Ensure consistency of labeling across product lines and compliance with policies and procedures and applicable regulatory authority directives and regulations
- Analyze competitor labeling and ensures products have most competitive labeling
- Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities
- Oversee EU and GM translations process
- A minimum of 5+ years in Regulatory, R&D or related area, at least 3 years of experience in labeling or equivalent experience within the pharmaceutical industry
- Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling
- Knowledge of and experience with Asia and Emerging Market labeling desirable
- Experience in both local and global regulatory labeling environments
- Minimum of a Bachelor’s Degree or higher in life science
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.