Job Description

We are working with an exciting and growing Cell & Gene Therapy company with a unique and rather special portfolio of mixed products and modalities, across a range of rare genetic diseases.

Our client offers a mixed and a diverse working environment, focused on inclusion and collaborative working. The culture is built around offering new opportunities for development, training, growth, and with big(ger) plans for growth in 2023, this is a great time to be part of a company making great strides in the Cell and Gene Therapy sector.

Our client is now looking for a Medical Writing Associate Director, who has the capability to lead a medical writing function and also the development of key documents supporting clinical programs and regulatory submissions. With this opportunity, you will collaborate with cross-functional teams including representatives from clinical operations, regulatory affairs, medical, biostatistics, drug safety/pharmacovigilance, clinical pharmacology, translational medicine, data sciences, and program management for indications in early and mid-development.

The role reports into a hugely experienced Head of Regulatory Affairs, who is also super supportive and keen for her team members to always feel challenged and independent, but always as part of the group. The writing team partners with functions across the development organization, offering broad exposure to the business and providing the ability to influence and help shape the future of the organisation.

Duties:

• Coordinate development of, and serve as principal writer for, clinical protocols/amendments, clinical study reports, investigator brochures, Module 2 summaries and other elements of regulatory submissions as well as abstracts, posters, and manuscripts
• Organize and lead document development and review meetings
• Develop and ensure adherence to clinical and regulatory writing timelines, standards, and processes
• Critically review statistical analysis plans to ensure alignment with anticipated data presentations in clinical study reports and Module 2 summaries
• Perform literature-based research to support writing activities
• Lead medical writing and cross-functional initiatives pertaining to document standards, template development, and processes

Experience:

• Clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
• A Bachelors, Masters, PharmD or Ph.D. in a life science or health discipline
• A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
• Demonstrated understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.) and experience as a lead author with such documents.

The role can be fully remote, and comes with a generous package, including a strong basic, competitive bonus and exceptional LTi scheme in the form of RSU’s.

If you are interested in hearing more about this or other roles in Medical Writing, please contact me, Theo Moore on 587.216.9302 or via email Theo@Advtalent.com, or my colleague Ivan Nash on +1-908-378-8980.