- 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 labeling 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 labeling is the most current, accurate, relevant and competitive to inform prescribers and patients
- Provide tactical guidance to product labeling review teams regarding labeling content development
- Recognize potential regulatory issues, solutions and opportunities
- Shows the value labeling brings to the business by owning labeling content
- 3 to 7 years 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 organizational skills, including the ability to prioritize 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 organized, detail oriented, highly effective written and oral communication skills
- Bachelor's degree in a scientific or medically related discipline preferred
-
Global Labelling Lead
2 weeks ago
Proclinical Staffing City of London, United KingdomAbout This RolenThe 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 products for patients and healthcare providers globally. · As the Global L ...
-
Global Labelling Lead
5 days ago
Proclinical Staffing City of London, Greater London, United KingdomAbout This Role · Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. · 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 saf ...
-
Global Labelling Lead
2 weeks ago
Proclinical Staffing City of London, Greater London, United KingdomBefore applying for this role, please read the following information about this opportunity found below.About This Role 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 ...
-
Global Labelling Lead
3 weeks ago
Proclinical Staffing City of London, Greater London, United KingdomAbout This Role 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 products for patients and healthcare providers globally.As the Global Labe ...
-
Node Developer
4 weeks ago
Understanding Recruitment City of London, United KingdomWe partner with a fintech start-up who are revolutionising company spending and expense management using brand-new scanning and zero-touch technology. This Node Developer role is around 70% Node and you will lead the development of new projects includingtheir white-label platform ...
-
Specifications Technologist
3 weeks ago
Kandhu Ltd City of London, United KingdomOPPORTUNITY HIGHLIGHTS · - Competitive Salary · - Fully remote role · - French Speaking role (Fluency is Essential) · SPECIFICATIONS TECHNOLOGIST On a day-to-day basis you will report into a Team Lead, who is responsible for delivery of services to one or more clients. Key respon ...
-
Investment Operations Technical Lead
2 weeks ago
S3 Associates Limited City of London, United KingdomOur client is an independently owned UK life company providing investment administration platform services to institutional pension schemes. Their award-winning investment platform is complemented by a range of investment services that includes a wide universeof funds for investm ...
-
Warehouse Operative
1 week ago
Gigbridge Ltd City of London, United KingdomAre you a Warehouse Operative in London? Would you like: · - To stop relying on recruitment agencies and group chats to find your next job? · - To get paid without any ridiculous payroll fees? · - To get notified immediately about the most recent jobs matching your skills, qualif ...
-
Team Lead
3 weeks ago
Proclinical Staffing City of London, Greater London, United KingdomThe 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 products for patients and healthcare providers globally. · As the Global Labelling Lead, ...
-
Fashion Garment Technologist
2 weeks ago
Orlebar Brown City of London, Greater London, United KingdomSalary: £k - depending upon experience · Orlebar Brown (Chanel group) launched in March 2007 as a more tailored approach to men's beach and swim shorts. Based on the traditional pattern of a tailored pair of trousers for men, and with their distinctive side fasteners, they are no ...
-
Clinical Supply Chain Senior Manager
3 weeks ago
Life Sciences Recruitment City of London, Greater London, United KingdomLocation: London office. Hybrid schedule: 4 days in-office, 1 day remote. · Ready to apply Before you do, make sure to read all the details pertaining to this job in the description below. · As the Manager of Clinical Supply Chain Management, under the Director's guidance, you'll ...
-
Project Statistician
12 hours ago
Proclinical Group City of London, Greater London, United KingdomThe successful candidate will be responsible for ensuring the delivery of individual studies and the overall program on time, within budget, and to the required quality. Evaluate database structures, edit checks and coding conventions of data management. · Preparing statistical ...
-
Director of Product Management
3 weeks ago
Intelligent People City of London, Greater London, United KingdomProduct Director | FinTech / Open banking | £120-130k + Equity | London (Hybrid) · Ready to make your application Please do read through the description at least once before clicking on Apply. · This is an incredible opportunity for a Product Director / Head of Product / Director ...
-
Principal Statistician
12 hours ago
Proclinical Group City of London, Greater London, United KingdomProclinical is seeking a dedicated and innovative Principal Statistician to join a dynamic team. This role will focus on leading the Biostatistics activities for a program of studies of moderate complexity. The successful candidate will be responsible for ensuring the delivery of ...
-
VAT Manager
1 week ago
LHH Recruitment City of London, Greater London, United KingdomAre you a passionate VAT professional looking for an new opportunity to develop your career within the advisory space. · LHH are working with a leading advisory organisation, they are looking for a VAT Manager to join their growing VAT Consultancy team. If you have expertise in ...
-
Retail Sales Consultant
3 days ago
twentytwentyone london (city of london), United Kingdomtwentytwentyone has been established for over 25 years as one of London's foremost retailers of classic and contemporary design. Supplying furniture, lighting and accessories from world leading designers and manufacturers. · We welcome applicants to join our growing and friendly ...
-
Senior Key Account Manager
3 days ago
SERVED® City of London, Greater London, United KingdomSenior National Account Manager - Grocery & Convenience · The Brand · Co-owned by Ellie Goulding, SERVED has quickly become one of the fastest growing ready-to-drink brands in the UK, with Heineken acquiring a significant minority stake in September 2023. · SERVED is now availabl ...
-
Berkmann Wine Cellars City of London, Greater London, United KingdomON-TRADE WINE SALES ACCOUNT MANAGER-London · 'Gastropubs' specialist · Berkmann Wine Cellars are proud to be the largest family owned and family-run wine importer in the UK. We've been selling premium wine to the on-trade since 1964 and our expertise has grown along with our port ...
-
Senior Regulatory Affairs
3 weeks ago
Cpl Life Sciences City of London, Greater London, United KingdomJob Title: Senior Regulatory Affairs & PV Manager · Employment Type: Permanent position · Location: East London, 3 days on-site. (Hybrid) · Remuneration: Competitive salary and package · Ready to apply Before you do, make sure to read all the details pertaining to this job in the ...
-
Retail Sales Consultant
3 days ago
twentytwentyone City of London, Greater London, United Kingdomtwentytwentyone has been established for over 25 years as one of London's foremost retailers of classic and contemporary design. Supplying furniture, lighting and accessories from world leading designers and manufacturers. · Apply now, read the job details by scrolling down Doubl ...
Global Labelling Lead - City of London, United Kingdom - Proclinical Staffing
Description
Job DescriptionAbout This Role
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 products for patients and healthcare providers globally.
As the Global Labelling Lead, you would 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.
What You'll Do
Create and update core labelling documents:
Oversee regional implementation:
Core labelling supporting documentation:
Maintain labelling compliance
Basic to advanced level of skill in key labeling capabilities including:
Required Skills
Preferred Skills
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
