Associate Director, Global Labeling Lead (hybrid)
An amazing opportunity has arisen for an Associate Director, Global Labeling to join our Global Labeling Therapeutic Area. The purpose of this group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which provide the safe and effective use of products for patients and healthcare providers globally.
Bring energy, knowledge, innovation, and carry out the following:
Developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines.
Developing, maintaining, and implementing US Labeling for assigned products in line with regulatory and internal standards and guidelines.
Assisting with developing and maintaining Local Labeling for assigned products.
Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory guidelines
Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling standards to support timely regulatory submissions for assigned products.
Leading cross-functional teams to develop, review, and approve Core and Local Labeling documents.
Providing information to Global Labeling Compliance, as needed, to support internal and external (i.e., Regulatory Authority) audits/inspections as a labeling subject matter expert.
Evaluating risks associated with Core or Local Labeling content, developing mitigation strategies, and appropriately escalating issues to Global Labeling management and the Global Regulatory Team
What skills you will need:
To excel in this role, you will more than likely have:
Bachelor’s degree in a scientific discipline. Advanced degree preferred (MS, PharmD, PhD).
Minimum of 5 years in labeling or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance) preferred.
Ability to guide cross-functional labeling team (including senior management) exhibiting a combination of active listening skills and the assurance to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling projects.
Self-starter with an ability to assimilate clinical and scientific information and present it concisely. Understanding of medical concepts and terminology.
Strong project management skills with the ability to handle multiple projects and prioritize work accordingly.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$118,640.00 - $186,800.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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