Regulatory Publishing Specialist
- Any EMEA Location, UK
- Medical Writing
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As a Regulatory Publishing Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
As a Regulatory Publishing Specialist you will be fully dedicated to a Top-5 pharmaceutical company. While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer-term career.
This role is home based in the UK or Europe
What you will be doing:
- Compilation and publishing of clinical documents
- Compile and publish all relevant clinical documents including but not limited to Clinical Trial Report (CTR) body and synopsis, CTR appendices, Investigator’s Brochures (IB), Non intervention Study Reports (NSRs), Lay summaries, submission documents and Q&A documents
- Perform additional processing of published documents (e.g. add cross-references/hyperlinks) to ensure that the published documents are compliant with all relevant internal and external requirements to PDF files intended for regulatory submissions.
- Ensure finalisation of documents
- Coordinate and ensure quality of CTR appendix material
- Plan and coordinate the collection of appendix material in collaboration with the medical writer, study group and local affiliates
- Check appendix documentation and ensure adherence to internal and regulatory publishing standards (e.g. regarding navigation, bookmarks, hyperlinks, margins, header).
- Ensure electronic quality control (eQC) of all clinical documents intended for regulatory submissions
You are:
- MSc., or equivalent
- Experience in regulatory publishing in CRO or pharma
- Experience in the routine use of Document Management Systems,
- Adobe Acrobat, Professional and MS tools
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Who we are
Similar jobs at ICON
Salary
Location
Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Belgium
Denmark
France
Germany
Netherlands
Spain
Switzerland
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be
Reference
2023-103952
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Europe, Germany, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Any EMEA Location
Germany
Switzerland
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will Lead, manage, and coordinate all
Reference
2024-111027
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Europe, United Kingdom, Belgium, Germany, Denmark, Spain
Department
Medical Affiars & Medical Writing Roles
Location
Any EMEA Location
Belgium
Denmark
Germany
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.We’re proud to foster an inclusive environ
Reference
2024-110789
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
France, Spain, Europe, United Kingdom, Germany, Belgium
Department
Medical Affiars & Medical Writing Roles
Location
Any EMEA Location
Belgium
France
Germany
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As a Senior Medical Writer you will be fully
Reference
2024-110665
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Spain, United Kingdom
Department
Medical Affiars & Medical Writing Roles
Location
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110064
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Poland, Romania, Hungary, Slovakia
Department
Medical Affiars & Medical Writing Roles
Location
Hungary
Poland
Romania
Slovakia
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
Senior Clinical Trial Transparency Associate is responsible for CTT deliverables, the role is single sponsor dedicated. The role can be based in Eastern Europe
Reference
2024-110086
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia Roth