Technical Project Manager
Short Hills, NJ 07078
6 month contract
• Responsible for the maintenance of labeling submission plans to ensure correct components and timelines are captured; prepare all Structured Product Labeling (SPL) format for all submissions;
Support for the collection of ancillary documents supporting submission.; Support for labeling meetings in meeting minutes and capturing detailed labeling revisions during the meetings.
• Manages complex labeling changes that span across therapeutic areas and multiple products; Authoring of administrative cover letters and forms to support labeling submissions; Proof read all labeling versions (clean, annotated, marked) and ensure consistency and accuracy across all documents;
• Work closely with Labeling Specialists & Therapeutic leads to ensure all components are organized and accurate for the submissions.
MUST HAVE REGULATORY AFFAIRS/ LABELING EXPERIENCE
• Master's degree required in science or related field (advanced degree preferred)
• In depth working knowledge of sections of core data sheets and prescribing information inserts as well as Structured Product Labeling (SPL) software and desktop applications including MS Word, Excel, and Adobe Acrobat Professional
• Effective time management and organizational skills to efficiently manage multiple time-sensitive complex assignments simultaneously
• Demonstrates strong attention to detail in performing editing and proofreading functions and has a deep understanding of the medical need and business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables
• Demonstrates the ability to independently solve a range of straightforward problems that arise within job responsibilities and expectations
• Effectively communicates difficult issues both verbally and in writing, and persuades others in straightforward situations
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
• MS Word, Adobe Acrobat Professional, SPL software, and project management expertise•
• At least seven years of relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields.