Global Labeling Lead, Senior Manager
Location:
Groton, Connecticut
Posted:
November 03, 2016
Position Type:
Full Time
Category:
Project Management, Quality Assurance
Reference:
1041666


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The Global Labeling Lead (GLL) has overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.

The GLL will drive labeling strategy by guiding and advising the Labeling Team on internal labeling guidance and policies and will raise awareness of important factors to consider when revising the label. The GLL will keep up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles. The GLL will also be knowledgeable on key labeling requirements worldwide. The GLL will ensure that downstream impact on Country Labeling Documents (CLDs) is considered during Labeling Team discussions. The GLL will advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text.

The GLL provides project management to the Labeling Team throughout the entire process, from the request to update a CDS/USPI/SPC through notification to stakeholders, in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets and prioritization plans, ensuring that Labeling Teams are aware of the required timelines and following up with Labeling Team members throughout the process so that deliverables remain on target to meet internal and external deadlines.

The GLL serves as the GLM primary point of contact for Labeling Team members (e.g. Regulatory Strategist, Safety Risk Lead, Functional Line SMEs, Labeling Justification Document/Clinical Overview author) and will provide day-to-day direction to Labeling Operations Specialists so that labeling can be prepared and managed appropriately throughout the company processes and systems. The GLL also interfaces with Hub Labeling Managers and the company Country Office (PCO) colleagues to support timely and quality submissions globally.

The GLL will support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.

Responsibilities
• Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. Manage complex labeling projects (e.g., development labeling for NCEs and NMEs) with some oversight.
• Engage in and contribute to Labeling Team discussions around content and format of the above mentioned documents, as well as downstream impact on CLDs worldwide.
• Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can be incorporated into CLDs worldwide.
• Prioritize Labeling Team activities and set clear targets using effective project management. Follow up with Labeling Team members to secure their contributions so that internal and external deadlines are met. Identify and assist teams to overcome barriers in achieving quality and compliance.
• Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
• Contribute to the development of continuous improvement of business practices associated with processes and tools. Advocate for new labeling initiatives to immediate labeling stakeholders (e.g., Labeling Teams).
• For deliverables in scope, support responses to inquiries from the company colleagues related to inspection activities and regulatory agency questions.
• Member of teams tasked with development of continuous improvement of business practices associated with processes and tools.
• Advocate for new labeling initiatives to labeling stakeholders within Therapeutic Area or Business Unit.
• Will train and provide guidance to other Global Labeling Leads as needed.

Qualifications
Education:
Life sciences, pharmacy graduate or equivalent.
Advanced academic qualifications/degree such as PhD an advantage but not essential.

Experience and Attributes:
• At least 8 years of pharmaceutical labeling experience:
• 'Hands on' pharmaceutical labeling experience associated with content development and maintenance within Regulatory Affairs (Human Medicinal Products); Perspective from HQ, Country office and/or Regional Regulatory Strategy (at a global/multi-national pharmaceutical environment) necessary. Experience at the country level important and advantageous.
• Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS); experience in reviewing and understanding of implications of the CDS.
• Possesses advanced knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
• Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
• Demonstrated ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
• Demonstrated ability to develop strong and positive working relationships across multiple cultures and within global environment.
• Knowledge of global/regional regulatory guidelines and requirements important.
• Excellent written and verbal communication skills essential.
• Complete fluency in English Language.
• Proven strength in logical, analytical and writing ability essential.
• Strong project management skills and attention to detail required.
• Proven ability to negotiate, influence and problem solve.
• Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels.
• Demonstrated knowledge and understanding of company Core Data Sheets and the dynamics of Labeling Team purpose and objectives.
Demonstrated ability to understand how updating one section of a label may impact another and to propose recommendations to the Labeling Team.
• Clear and effective written and verbal communication skills. Ability to liaise with stakeholders using effective means of communication. Demonstrated ability to influence and negotiate where necessary, across a highly matrixed team.
• Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
• Ability to interact effectively with all levels/roles of project team members.
• Ability to manage own time for all projects, and to work on many tasks in parallel.
• Takes ownership and accountability for assigned projects.
• Proven ability to effectively lead Labeling team members to facilitate agreements, drive the Labeling Team toward its goals, and resolve issues.
• Consistent ability to foster strong matrix team working relationships. Proven track record of facilitating groups of individuals across groups to work together on creating solutions.
• Proven ability to make sound decisions even in ambiguous situations. In doing so, the job holder will proactively seek information and insight from a broad range of sources and weigh benefits and risks before making important decisions. Interfaces directly with senior management as appropriate on labeling content and requirements.
• Interfaces directly with senior management as appropriate on prescribing information content and requirements.
• Independently seeks to identify and resolve problems in a proactive manner.

Other Information - Internal
UK is grade 14, NYC and Peapack is grade 12, all other locations are a grade 11.

Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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