Regulatory Writer-Clinical, Leaders in drug development, UK

I have got a great remote opportunity (you can be based anywhere in Europe) for an experience writer to join a leading global company.

You will be working alongside some of the strongest industry talent, including leaders, writers, editors and regulatory submissions specialists. You will be able to bring your existing experience as well as learn from your peers as the work includes a lot of collaboration between various departments.

Responsibilities:

• Author documents per client specifications, templates, style guides, and other guidance documents
• Author documents per regulatory authority guidelines and requirements
• Usher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus
• Lead a project team, actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)

Requirements:

• Minimum BA in Life Sciences, Biomedical degree or similar subject area

• 10+ years of regulatory writing experience with nonclinical, clinical, CMC or pharmacovigilance related (SD2) documentation
• God knowledge of global health authority, regulatory requirements for different phases of development and different regulatory pathways
• experience writing and leading a range of documents in their entirety (e.g. study and submission level, pharmacovigilance)[SD3]
• understanding of the document creation process and of the drug development lifecycle

Benefits:

• Work for a world leader in the field of Life Sciences
• Excellent opportunity to start or continue your experience within Regulatory Affairs
• Great location in Warsaw

Please share your CV in a Word format to discuss this opportunity further.

This opportunity can be remote across Europe so candidates from the UK, Belgium, Netherlands, Germany, etc. are welcome to apply.

The job market changes very quickly so do not forget to connect with me on Linked in, check other roles that I am hiring for at the moment and follow for any future relevant roles.

NonStop is dedicated to raising the standard of ethical recruitment and comprises a number of brands, each having their own niche.