Job Description

Overview:
TekWissen is a global workforce management provider throughout the UK, Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.
Job Title: HUB LABELING MANAGER
Location: Walton Oaks, UK
Duration: 12 Months
WorkType : Hybrid
:

• This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in client location.
• The incumbent will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle.
• This will involve generation and review of design history file and risk management file components whilst interacting with cross functional development teams at all levels of the organisation.

POSITION RESPONSIBILITIES

• Indicate the primary responsibilities critical to the job.
• Monitors system data integrity and quality checks.
• To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking system.
• Produces labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supporting documentation.
• Performs QC check of other colleagues' work.
• Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
• Meets defined targets on productivity, quality and compliance, as set by and overseen by management.
• To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate.
• To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.
• To work on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval; with a particular focus on digital solutions.
• To take part in research incubator work leveraging technologies in process automation, machine-learning, business process management etc.
• To work with R&D lead(s) with digital transformation project activities, to transform regulatory data, systems and processes into an integrated, hyper efficient learning platform, corresponding to GRS's overarching roadmap.
• To assist with labeling data analysis.
• To create or enhance SharePoint web pages.
• The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as complex revisions
• For deliverables in scope, prepares responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represents Pfizer during HA Inspections

EDUCATION, SKILLS, AND EXPERIENCE
QUALIFICATIONS / SKILLS

• Associate
• Proficient in the use of systems consistent with business expectations, and understands the importance of systems in maintaining high compliance figures.
• Fluency in the English language is important; however, multi-language skills are advantageous.

QUALIFICATIONS

• Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.

EXPERIENCE
Required

• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
• Demonstration of attention to detail and problem-solving skills.
• Proven technical aptitude and ability to quickly learn new software.
• Proven technical aptitude and ability to quickly learn regulations and standards.
• 'Hands on' registration experience associated with development, maintenance, and commercialization activities within Regulatory Affairs; preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous, especially with the perspective of the implications of a Core Data Sheet on LPDs.
• Ability to understand, assess, and manage the regulatory implications of product strategy with regard to the product label
• Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations, is important.
• Demonstrated project management, attention to detail, and problem-solving skills.

Preferred

• Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
• Proven strength in logical, analytical and writing ability essential

ORGANIZATIONAL RELATIONSHIPS

• Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities.
• Include any external interactions as appropriate.
• Reporting relationship to Regional Labeling Head and International Labeling Team Lead.
• Partners with Pfizer PCO's, GRS groups, GRO groups and other platform lines as required.
• Supports global, GRS, GRO and ILG initiatives as required.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Skills Required