Job Title: Hub Labeling Manager
Location: Tadworth, UK
Duration: 12 Months
WorkType : Onsite
Pay rate: £ 25.00 - 25.00/hr.
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 Description:
Hub Labeling Manager
- The HUB Labeling Manager will be responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their assigned markets and updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements.
- This role may act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence in collaboration with other Hub Labeling Managers.
- Additionally, this role will serve as an SME for the use and development of current and new global tools, technologies and processes to support label development, submission and approval; with a particular focus on digital solutions.
JOB RESPONSIBILITIES
- Maintains system management for labeling activities including Global Document Management System (GDMS) and client approved labeling tracking system.
- Maintenance of workflow management tools and mailboxes.
- Monitors system data integrity and quality checks.
- Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs.
- Produces other 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.
- Utilizes 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.
- Supports provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.
- Works 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.
- Takes part in research incubator work leveraging technologies in process automation, machine-learning, business process management etc.
- Works 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.
- Assists with labeling data analysis.
- Creates or enhances 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 client colleagues in response to inspection activities and regulatory agency questions, and represents client during HA Inspections.
QUALIFICATIONS
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
- Fluency in English language important however multi-language skills are advantageous.
- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.
- Knowledge of key regulatory and labeling principles and local regulations.
- ‘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.
- 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.
- 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.
- 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 preferred.
- Demonstrated project management, attention to detail and problem-solving skills.
- Provenstrength in logical, analytical and writing ability essential.
SKILLS
- Strong knowledge/understanding of the principles and concepts of labeling.
- Strong knowledge of key regulatory and labeling principles and local regulations.
- Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures.
- Clear and effective written and verbal communications.
- Understanding of the importance of SOPs, systems and processes in underpinning quality and compliance of deliverables.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
