Pfizer Global Labeling Lead in Collegeville, Pennsylvania
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 Pfizer processes and systems. The GLL also interfaces with Hub Labeling Managers and Pfizer 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.
Life sciences degree, 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.
EEO & Employment Eligibility
Pfizer 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. Pfizer 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. Pfizer is an E-Verify employer.
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Additional Offer Details:
Last Date to Apply for Job: 10/5/17
This job is Pfizer Exempt US Grade: 12 This role can be virtual
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer 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. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.