Global Labeling Lead
Company: ProClinical Ltd
Location: New York
Closing Date: 02 Mar 17
Salary (£): Competitive
A mid-sized pharmaceutical, headquartered in India, is seeking a Global Labeling Lead to based at their offices in New York, USA. Position Purpose:
The Global Labeling Lead job holder has overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. ...
A mid-sized pharmaceutical, headquartered in India, is seeking a Global Labeling Lead to based at their offices in New York, USA.
- The Global Labeling Lead job holder 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. This may also include Regulatory Authority driven documents such as the Core Safety Profile.
- The GLL will guide and advise the Labeling Team on internal labeling guidances 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, in order to ensure that CDS updates may be implemented globally.
- 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.
- Engage in and contribute to Labeling Team discussions around content and format of the above-mentioned documents, as well as downstream impact on LPDs worldwide.
- Act as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can be transcribed into the LPDs worldwide.
- Prioritize Labeling Team activities and set clear targets using project management tools. 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.
- Champion continuous improvement of business practices associated with processes and tools through liaison with Hub Labeling Managers, Labeling Operations Specialists and Regulatory Strategists.
- For deliverables in scope, support responses to inquiries from Client colleagues related to inspection activities and regulatory agency questions.
Education and Knowledge:
- Life sciences, pharmacy graduate or equivalent.
- Advanced academic qualifications/degree such as PhD an advantage but not essential.
- Knowledge of global/regional regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
- 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.
- Fluency in English language important; multi-language skills are advantageous.
Experience and Attributes:
- Significant 'hands on' registration experience associated with development, maintenance and commercialization activities 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); experiences of review and implications of the CDS an advantage.
- 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 locations.
- Understanding of regulatory authority philosophy and expectations.
- Knowledge of global/regional regulatory guidelines and requirements important.
- Excellent written and verbal communication skills essential.
- Complete Fluency in English Language.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.