Bristol-Myers Squibb

EU Labeling Operations Associate Director

Posted on: 20 Dec 2022

Plainsboro, NJ

Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us

Position Summary

Manage the EU Labeling Operations team.
Serve as the Labeling Operation lead Deputy.
Serve as the Subject Matter Expert (SME) in EU labeling requirements and supporting operational activities.
Mentor and guide EU Labeling Operations team members to maintain accurate, consistent, prioritization of the book of work, procedural documents and compliant labeling documentation for submissions to the EMA.
Ensure timely and accurate labeling documents and implementation of product labeling for EU launches.

Position Responsibilities

Manage EU labeling Operations Team to ensure all activities are aligned, compliant, and employ best practice and meet GRS and BMS strategic imperatives and EMA regulations.
Influence other functions by sharing best practices and providing guidance and mentorship.
Lead cross-functional labeling initiatives, companywide. Advising on labeling topics of corporate projects and initiatives.
Prioritize company objectives for department and advises leads and coordinators on departmental focus and supporting goals.
Maintain and contributes to Labeling Operations’ departmental SOPs and process flow maps while actively assessing for improvements.
Contribute to special process-related initiatives with strong knowledge and understanding of labeling processes and other related processes; participates in global regulatory and project development teams as necessary to identify, evaluate, and provide guidance on operational issues.
Represent Global Labeling Operations in a professional manner within BMS and externally at conferences

Experience and Qualifications Required

A degree preferred in science with 5 years of direct labeling operational and artwork experience in a regulated environment with 2 year in the pharmaceutical industry.
Direct People Management Experience required.
Must possess an excellent command of language (English).
Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities Excellent communication and organizational skills and a meticulous eye for details.
Solid understanding of EMA Regulatory and Labeling regulations and standards.
Experience in quality control of documents in different languages and format.
Experience of working on large and demanding translation projects managed in team and autonomously.
Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; willing to learn additional applications as needed. Additional industry systems preferred (e.g. Trados, EDMS, End to End tracking systems).
Experience working on multi-disciplinary teams and projects.
Ability to align personal objectives with the Packaging and Labeling and business strategies in order to make the best possible judgments.
Professional knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control).
Experience of the complexities of EU Health Agency requirements.
Excellent communication and organizational skills and a meticulous eye for details.
The ability to work as part of a team that supports global functions with a high level of professionalism.
Knowledge/ understanding of another language in the region supported preferred

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.K. to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.K. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. 

If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.K. and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or in any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com.

Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. If you require reasonable adjustments in completing this application, or any part of the recruitment process, direct your enquiries to adastaffingsupport@bms.com. Applicants can request an approval of an adjustment prior to accepting a job offer.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol-Myers Squibb

New York, New York

Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. The company offers drugs in oncology, immunoscience, cardiovascular, and fibrotic diseases. The company’s products include Opdivo, a biological product for anti-cancer indications; Eliquis, an oral inhibitor targeted at stroke prevention in adult patients with non-valvular atrial fibrillation, and the prevention and treatment of venous thromboembolic disorders; and Orencia, a biological product for adult patients with moderately to severely active RA and prostate-specific antigen, as well as reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.

It also provides Sprycel, a tyrosine kinase inhibitor for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia; Yervoy, a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma; Empliciti, a humanized monoclonal antibody for the treatment of multiple myeloma; and Baraclude, an oral antiviral agent for the treatment of chronic hepatitis B. In addition, the company offers Reyataz, a protease inhibitor for the treatment of human immunodeficiency virus (HIV) and Evotaz; Sustiva franchise, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV; and Daklinza NS5A replication complex inhibitor, Sunvepra NS3 protease inhibitor, and Beclabuvir NS5B inhibitor. It sells products to wholesalers, retail pharmacies, hospitals, government entities, and medical profession. It has collaboration agreements with Nektar Therapeutics; Janssen Pharmaceuticals, Inc.; Biocartis Group NV.; and FameWave Ltd.

The company was formerly known as Bristol-Myers Company and changed its name to Bristol-Myers Squibb Company in 1989. Bristol-Myers Squibb Company was founded in 1887 and is headquartered in New York, New York.

  • Industry
    Biopharmaceuticals
  • No. of Employees
    23, 300
  • Jobs Posted
    1641

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