Job description

Responsibilities:

• Excellent employment opportunity for a Product Labeling Operations Manager in the Ridgefield, CT area. (Hybrid)
• With minimal assistance from Senior Labeling Management: Marketed products and Late-Stage Development Projects
• Actively lead the execution and coordination of assigned operational labeling activities in conjunction with the assigned DRA product responsible colleagues in the DRA Product Groups and DRA Product Labeling Content Group.
• Ensure US marketed product labeling is compliant with Corporate Design and in a manner consistent with local regulations.
• Develop subject matter expertise for labeling operational activities, including development/improvement of training and coaching tools.
• Lead and/or participate on internal working groups as appropriate to develop and/or streamline business processes.
• In a leadership role, must be able to lead specific strategy/planning activities for labeling implementation.
• When confronted with more complicated/novel matters, exercise sound judgment in escalating matters for management guidance.
• Continuously evaluates innovative opportunities to improve efficiency and execution of process.

Experience:

• BA/BS degree preferred with 5 years of experience in the Pharmaceutical industry and a minimum of 3 years labeling experience preferred which is required in order to be able to properly understand the implications of labeling decisions throughout the business, and to manage work in a dynamic environment.
• Excellent communication and interpersonal skills in a strongly collaborative, multi- stakeholder environment.
• Excellent verbal, written and presentation skills, with strong attention to detail.
• Demonstrated people/Project Management with excellent planning and organization.
• Demonstrated knowledge of regulatory labeling and compliance requirements, including technology trends.
• Excellent proofreading/editing skills; excellent usage of the English language (spelling, grammar, and punctuation); excellent communication skills.
• Ability to work in a team environment with personnel within DRA as well as other functions and other external vendors.
• Ability to perform diverse and complex tasks including experience with complex database applications used for monitoring labeling life cycle.
• High level computer literacy and able to adapt promptly to change.
• Requires proficient knowledge of US regulatory environment in product labeling requirements to ensure product labeling is maintained in a timely and accurate manner
• Knowledge of FDA regulations, guidances regarding labeling requirements, demonstrating high proficiency in interpretation of evolving requirements.
• High level of experience and knowledge of Structured Product Labeling (SPL).
• Must have exposure to package labeling development and implementation, including experience with drafting carton and container labeling and reviewing product labeling and compilation of supportive documentation to meet local compliance requirements.
• Strong grammatical and proofreading/editing background required.
• Excellent knowledge of applicable FDA regulations, guidelines and initiatives regarding the operational aspects of labeling.
• Abreast of regulatory requirements on labeling content.
• Ability to evaluate the implication of regulatory requirements and internal process on labeling implementation to meet business and compliance objectives.
• Supervisory experience preferred.
• Required Skills: EDITING/PROOFREADING/WRITING, EXCELLENT COMMUNICATION SKILLS, FDA COMPLIANCE

Job Type: Contract

Salary: $26.00 - $34.00 per hour

Schedule:

• 8 hour shift
• Day shift

Work Location: One location

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