Global Labelling Lead
| Posting date: | 26 April 2024 |
|---|---|
| Salary: | £90 to £110 per hour |
| Hours: | Full time |
| Closing date: | 17 May 2024 |
| Location: | Maidenhead, Berkshire, SL6 3UD |
| Company: | Randstad CPE |
| Job type: | Contract |
| Job reference: | GLLB_1714129362 |
Summary
Are you an experienced Labelling Lead? Do you have pharmaceutical or biotechnology regulatory experience, including regulatory labelling? If so, our Biotechnology client is looking for individuals just like you!
The purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our clients products for patients and healthcare providers globally.
The Global Labelling Lead will be responsible for developing the strategy and leading the development and update of core labelling documents and for overseeing implementation at a local and regional level.
This is a contract position offered initially on a 12 month contract basis in Maidenhead working 37.5 hours a week Mon-Fri.
Responsibilities:
- Lead the timely creation/management of regulatory compliant, competitive and up to date core labelling documents throughout the product lifecycle including the Company Core Data Sheet (CDS), Global Patient Leaflet and Target Label Profile
- Lead cross functional product Global Labelling Team to reach consensus on core labelling matters, accurately capture and communicate decisions, and obtain endorsement by senior management
- Propose the strategy to be followed in core labelling documents, ensuring alignment with global regulatory strategies
- Oversee distribution and tracking of CDS updates, ensuring compliance is maintained within the EDMS and the Regulatory Tracking System
- Oversee timely implementation of CDS updates in regional labels and monitor compliance to labelling processes
- Support Regional and Local Regulatory Leads in responding to Health Authority queries related to labelling and collaborate with Regulatory Leads to identify and track Country Labelling Differences
- Oversee preparation of supporting documents for core labelling changes, in collaboration with Medical Writing, ensuring alignment to the core labelling strategy and global regulatory strategy
- Maintain labelling compliance for assigned products ensuring version control and tracking of CDS implementation in relevant company systems
- Create, maintain and update regulatory labelling procedures and SOPs and support relevant audits and inspections
- Maintain knowledge of current rules and regulations governing global labelling activities
- Provide training to internal stakeholders, new joiners on labelling process requirements and content standards
- Understand scientific concepts to critically assess clinical data, enable proactive interactions with appropriate stakeholders, influence the clinical development plan
- Develop and implement strategy for global labelling content
- Identify underlying processes and principles for developing product claims representing the risks and opportunities to the project team
- Partner with key stakeholders to ensure product labelling is the most current, accurate, relevant and competitive to inform prescribers and patients
- Provide tactical guidance to product labelling review teams regarding labelling content development
- Recognize potential regulatory issues, solutions and opportunities
- Shows the value labelling brings to the business by owning labelling content
Experience and skills:
- Bachelor's degree in a scientific or medically related discipline preferred
- Previous pharmaceutical/ biotechnology industry regulatory experience, including regulatory labelling
- Proven experience with document management and regulatory tracking systems
- Demonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterparts
- Demonstrate strong organisational skills, including the ability to prioritise personal workload
- Ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Strong sensitivity for a multicultural/multinational environment
- Well organised, detail oriented, highly effective written and oral communication skills
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.