New

Position Applying For:Technical Project Manager II (Global Labeling) - 100% Remote

Join & Explore The Possibilities at BuzzClan

  • Technical Project Manager II (Global Labeling) - 100% Remote  | USA-NJ-SHORT HILLS  |  | 14-APR-21 
    RESPONSIBILITIES
    
• Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, CSI, 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.
    
• Oversee and direct Labeling Operations Managers.
    
• Communicate label update plans to the Hub Labeling Managers in a timely manner.
    
• 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.
    
• Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.
    
• Champion continuous improvement of business practices associated with processes and tools through liaison with Hub Labeling Managers, Labeling Operations Managers and Regulatory Strategists.
    
• For deliverables in scope, support responses to inquiries from Pfizer colleagues related to inspection activities and regulatory agency questions.
    

    
QUALIFICATIONS / SKILLS
    
Qualifications
    

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

    Qualifications


    
Technical Skills
    

    
• 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, Core Safety Information documents 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.
    
• 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.
    

    
Additional information:
    

    
Core data strategy
    
European and us market
    
Life cycle management on CDS
    
Managing products
    
Negotiating skills
    
Understanding and management in mrp submission
    
Labelling exp
    

    
• CCDS
    
• Global labelling exp
    
• Core date sheet
    
• Safety info
    
• European market
    
• life cycle management of the product
    
• Clinical Validation
    
• Pharma background
    
• Relevant endorsement from Committee members / board members / group members
    
• 10 years of core labelling exp