Labelling Associate Director
CK Group are recruiting for a Labelling Associate Director to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 6 months. This role can offer fully remote working option.
Salary: Up to £75 perhour LTD / UMB or £65 per hour PAYE
Company: Our client is a global research-based bio pharmaceutical company with a major UK presence who are committed to making a meaningful impact on people’s lives with life-changing medicines. This is a worldwide brand name which will not only look fantastic on your CV for years to come but also offer inspiring and rewarding work.
Location: Cambridge. This site is one of the most exciting bioscience hotspots in the world. It is the largest researchand development centre in the UK, designed to hold more than 2,000 people working across therapy areas and drug discovery and development.
Rewards: People are at the very heart of this organisation, and their facilities support this. You will find an onsite gym, restaurants, parking, on-site holiday childcare and much more!
- Weekly/monthly payroll options
- Timesheet system
- Bike schemes
QC Chemist Role:
- Ensures that the labelling process is followed through the lifecycle of the product.
- Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
- Leads the development of the labelling strategy, in line with the overall regulatory strategy for theproduct.
- Leads the PLT in the preparation and maintenance of high quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with theaim of achieving advantageous labelling.
- Leads the development of labelling negotiation strategies, anticipating HA perspectives.
- University Degree in Science or related discipline
- Pharmaceutical experience, includingregulatory experience, preferably working with labelling
- Knowledge of labelling regulations and guidances
- Excellent verbal and written communication skills
- Ability to think strategically, appropriately assess risks and formulate strategiesto manage risk
Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53648 in all correspondence.