Boehringer Ingelheim Manager, RA Product Labeling Operations in RIDGEFIELD, Connecticut
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
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
Based on organizational need supervise assigned DRA Product Labeling Operations staff members
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Actively lead the execution and coordination of labeling operational activities for assigned BIPI Marketed products. This may include but is not limited to, participation at Product Labeling Review Team meetings, internal labeling approval process as specified by best practices and office procedures; ensuring US marketed product labeling is compliant with Corporate Design and with local regulations.
Takes on delegated role for ad hoc project assignments where DRA Product Labeling operations representation is needed.
Independently communicate via established procedures with Graphics Office to revise and create artwork for various labeling components for assigned BIPI marketed products. Ensure that timelines for revised artwork are adhered to as to minimize impact on production. Collaborate with planning function to escalate and present requests to senior management to deviate from compliance implementation dates.
Attend SLCI job board and communicate upcoming labeling changes and submission strategies to impacted areas of the business. Responsible for ensuring KPIs assigned by the business are met.
Contribute to Annual Labeling Reviews: A) Ensure product labeling is reviewed on an annual basis and input is provided to PLRT for consideration at the annual label review B) Ensure summary of labeling changes is prepared in compliance with business timelines C)Provide sign off of annual labeling reports in absence of label management.
Provide guidance on annual reporting label requirements and ECTD structure to the labeling specialists.
Prepare, maintain, and update official BIPI labeling files (hard copy and electronic). Review and analyze labeling files for historical information and write reports for legal inquiries related to product labeling revision
Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents, for example, SPL, MS Word files, Artwork needed for labeling submissions with contributing functions in other DRA groups such as DRA Product Labeling Content, DRA Operations, and DRA Product Groups.
Proofread labels/labeling for accuracy to confirm compliance with FDA requirements. Interact with Corporate Design Office as needed for US labeling changes to ensure consistency with design guidelines or requests for local deviations.
Proactively identify gaps in processes and scope; develop new standard operating procedures, lead implementation of continuous system improvements, maintain and enhance workflow tools used for electronic routing and approval of labeling change requests
Bachelors’ degree preferred with five (5) years’ experience in the pharmaceutical industry and a minimum of three (3) years labeling experience or ten (10) years’ experience in the pharmaceutical industry with a minimum of three (3) years labeling experience required in order to be able to properly understand the implications of labeling decisions throughout the business and to manage work and possibly supervise employees in a dynamic environment.
One (1) to three (3) years employee and project management/leadership experience
Highly specialized and detailed-oriented position.
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.
Excellent planning, organizing and decision-making capabilities.
Must be able to handle multiple priorities, resolve conflicts and solve problems with minimal supervision in a dynamic environment.
Must use sound judgment in elevating particularly complex matters to appropriate management for high level resolution.
Supervisory experience preferred.
Excellent proofreading/editing skills; excellent usage of the English language (spelling, grammar, and punctuation); excellent communication skills; the ability to work well under pressure and adapt to changing priorities.
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 lifecycle. 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 to comply with FDA regulations and to communicate essential product information to the marketplace. If labeling implementation is not managed well, regulatory/legal consequences could be severe in terms of patient safety, product integrity, and company credibility.
High level of experience and knowledge of Structured Product Labeling (SPL).
Preferred supervisory experience in a dynamic environment with demonstrated ability to manage people and projects with changing priorities.
Desired Experience, Skills and Abilities:
- 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.
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. Ben Venue Laboratories Inc. and Boehringer Ingelheim Fremont, Inc. is an equal opportunity employer. Minority/Female/Protected Veteran/Person with a Disability
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Organization: US-BI Pharma/BI USA
Title: Manager, RA Product Labeling Operations
Requisition ID: 1811911