Global Labelling Senior Associate
3 weeks ago
About This Role
The purpose of the Global Labelling group is to drive Biogen’s regulatory 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 Senior Associate, you will be responsible for:
- Supporting the development and update of artwork components.
- Supporting the development, update and implementation of labelling documents.
What You’ll Do
- Responsible for initiating Regulatory-driven new and updated artwork via Change Management System.
- Record regulatory assessments and ensure Change Management System is appropriately linked to the Regulatory Tracking System.
- Provide oversight and lead Change Management Team meetings with Product Lifecycle & Change Management, Supply chain & Planning.
- Act as intermediary between Regulatory Leads, Affiliates and Partners and Change Management Team to ensure changes to the planned activity and implementation timelines are communicated.
- Review and approval of artwork/mock-ups as required.
- Update Market Requirements Document in Change Management System.
- Contribute to launch team meetings (in partnership with Regulatory Lead) and prepare launch artworks.
- Oversee EMA linguistic review process, for MAA or post-approval, with the translation vendor.
- Audit and compliance support impacting artwork.
Who You Are
You will have a passion for regulatory labelling and artwork implementation, and an excellent eye for detail. You will also have a demonstrated understanding of the importance of labelling governance and compliance.
Qualifications
Required Skills
- Bachelor's degree in a scientific or medically related discipline.
- Proven work experience in the pharmaceutical/ biotechnology industry, preferably including experience within artwork/labelling operations.
- Experience with EDMS and regulatory tracking systems.
- Awareness of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development.
- Demonstrates 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.
- Proficient computer skills with the Microsoft suite of products, primarily Word, Excel, PowerPoint.
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
-
Global Labelling Senior Associate
3 weeks ago
Maidenhead, United Kingdom Biogen Full timeJob Description About This Role The purpose of the Global Labelling group is to drive Biogen's regulatory 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 Senior Associate, you will be responsible for:...
-
Global Labelling Lead
6 months ago
Maidenhead, United Kingdom Proclinical Full timeProclinical are recruiting for a Global Labelling Lead to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK. **Responsibilities**: - Suggest the method to be followed in core labelling documents, guarantee to be in line with international regulatory methods. - Supervise the...
-
Senior Label Operations Manager
3 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Biogen Full timeBiogen is committed to fostering a culture of innovation, diversity, and inclusion. As a member of our team, you will have the opportunity to work with cutting-edge technologies, collaborate with experts from various backgrounds, and contribute to the development of life-changing medicines.Job SummaryThe Senior Associate, Planning role is responsible for...
-
Senior Systems Architect
19 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Copello Global Full timeJob TitleWe are seeking a Senior Systems Architect to join our team at Copello Global.About the RoleThis is an exciting opportunity for a highly experienced Senior Systems Architect to lead our systems engineering efforts and deliver high-quality solutions.Key ResponsibilitiesLeverage your expertise in systems engineering to develop and implement robust...
-
Global Marketing Communications Specialist
4 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom FM Global Full timeJob Summary:We are seeking a highly skilled Marketing Planning Consultant to join our team in either London, Maidenhead, Frankfurt, Paris, or Luxembourg office. The ideal candidate will have a strong background in marketing planning, implementation, and evaluation, with a proven track record of delivering successful campaigns.This role is a key part of our...
-
Senior Systems Engineering Lead
3 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Copello Global Full timeCopello Global is partnering with an established Intelligence and Communications business to fill the role of a Senior Systems Engineering Lead.Location: MaidenheadSalary:£80,000 - £100,000 per annumJob DescriptionThis position will be responsible for representing the Systems discipline as a senior member and leading systems engineers on assigned work...
-
Senior Systems Architect
4 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Copello Global Full timeCopello Global - Principal System EngineerThis is a highly sought-after position for a Principal System Engineer/Systems Engineer Lead at Copello Global, an established Intelligence and Communications business.The successful candidate will be based in Maidenhead and receive a competitive package, including a company bonus, private medical care, and a DV...
-
Global Business Growth Associate
21 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Pharmiweb Full timeFoirtrea offers a unique opportunity to join our Inside Sales EU team as a Global Business Growth Associate. As a member of this team, you'll play a critical role in supporting business development and growth initiatives across Europe.About the TeamThe Inside Sales EU team is a high-performing team that drives business growth through strategic partnerships...
-
Senior Clinical Research Associate Lead
4 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full timeJob Title: Senior CRAFortrea, a leading global contract research organization (CRO), is seeking a seasoned Senior Clinical Research Associate (CRA) to join its Clinical Operations team in the UK. As a Senior CRA, you will play a crucial role in conducting national monitoring activities across various therapeutic areas, leveraging your expertise to drive...
-
Systems Engineering Manager
12 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Copello Global Full timeSenior Systems Engineer JobWe are seeking a Senior Systems Engineer to join our team at Copello Global.Role OverviewThis is an exciting opportunity for a highly experienced Senior Systems Engineer to lead our systems engineering efforts and deliver high-quality solutions.Key ResponsibilitiesLeverage your expertise in systems engineering to develop and...
-
Maidenhead, Windsor and Maidenhead, United Kingdom Copello Global Full timeCopello Global seeks an experienced Principal Systems Engineer to lead their Systems Engineering efforts in Maidenhead. This is a challenging opportunity to make a significant impact on the company's success.The role involves representing the Systems discipline as a senior member/leads SE for the totality of the Systems assigned work packages and tasking to...
-
Senior Claims Examiner
6 months ago
Maidenhead, United Kingdom FM Global Full timeFM Global has an opportunity for a Senior Claims Examiner to work in our London Operations Claims team based from the Maidenhead office. The role will involve the investigation, negotiation and settlement of Property and Business Interruption claims emanating primarily from the UK and also the wider Operations territory including Middle East and...
-
Maidenhead, Windsor and Maidenhead, United Kingdom Pharmiweb Full timeAbout the JobFortrea, a leading global CRO, is seeking a Senior Research Associate to join our Clinical Operations department in the UK. This role offers an exciting opportunity to work across a variety of therapeutic areas, including Oncology, and contribute to the development of life-changing therapies.About the Role:National monitoring across the UK and...
-
Senior Content Marketing Lead EMEA
4 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom FM Global Full timeJob Description:The Senior Content Marketing Lead EMEA will be responsible for developing and implementing content marketing strategies that support the company's global marketing objectives. This role requires a strong understanding of marketing principles, as well as excellent communication and project management skills.The ideal candidate will have a...
-
Global Clinical Trial Coordinator
4 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full timeOpportunity to Make a DifferenceAt Fortrea, we believe in the power of science to change lives. We are seeking an ambitious and detail-oriented individual to join our Clinical Operations Delivery Department as a Global Clinical Trial Coordinator. This role will provide you with the opportunity to gain hands-on experience in clinical trials from Phase I to...
-
Regulatory Affairs Associate
2 days ago
Maidenhead, United Kingdom Select Pharma Careers Full timeAn exciting new opportunity has arisen for a Regulatory Affairs Associate to join my client, a growing pharmaceutical company based in Berkshire. This role will suit a regulatory professional at the beginning of their career please note that 6 months to 1 year of regulatory experience is required.++ Please note that this role is fully office based (5 days...
-
Global Development Associate
4 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full timeInternship OpportunityFortrea's University Internship Program offers a unique opportunity to gain hands-on experience in clinical research operations. As a Clinical Research Intern, you will assist in the planning and execution of clinical trials, analyze data and identify trends, and develop and maintain project documentation.What You Need:Bachelor's degree...
-
Lead Systems Engineer
4 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Copello Global Full timeSenior Role for a Principal System EngineerWe are seeking an experienced Principal System Engineer/Systems Engineer Lead to join our team at Copello Global, an established Intelligence and Communications business.The ideal candidate will be based in Maidenhead and enjoy a competitive package, including a company bonus, private medical care, and a DV...
-
Senior Finance Business Associate
22 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Pulsant ltd Full timeWe are looking for a Senior Finance Business Associate to join our team at Pulsant Ltd in Maidenhead. The ideal candidate will have a proven track record in commercial Finance, with experience in financial planning and analysis, budgeting, and forecasting. Strong influencing and relationship building skills are essential, as well as advanced Excel skills and...
-
Senior Systems Engineering Lead
3 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Copello Global Full timeCopello Global, a leading intelligence and communications business, is seeking a highly skilled Principal Systems Engineer to join their team in Maidenhead.This role offers a competitive salary package, including a company bonus, private medical care, and a DV Clearance Bonus. As a British Passport Holder, you must be eligible for DV Clearance.As a Principal...