Medical Writer - Regulatory - Rare Disease
Orchard Therapeutics is a growing Gene Therapy company that is working on a life changing program that is at a late stage of development. As part of our on-going growth, we are currently recruiting for a Medical Regulatory Writer to join our rapidly expanding team.
This role will sit in the Regulatory Group and lead the writing of key regulatory documents (CTD modules, briefing documents, integrated safety and efficacy summaries for regulatory purposes…). The role will report to the Chief Regulatory Officer based in Europe. The Medical Regulatory Writer will collaborate with internal team members to interpret, distil, and summarize complex data concepts. The Medical Regulatory Writer will also set-up, manage and coordinate a team of external medical, clinical, non clinical writers, to be involved as appropriate to achieve submission timelines.
Other tasks might include participation in the preparation of non-clinical and clinical study reports, summarization of preclinical and clinical studies for preparation of investigator's brochures, literature reviews and referencing current research and regulatory guidelines for preparation of protocols.
Job Requirements & Education
Education to Bachelor’s/advanced degree level in a scientific discipline
Prior experience within medical regulatory writing, ideally in rare disease
Prior experience in CTD modules writing
Being able to bridge non clinical and clinical writing would be a plus
Excellent grammatical, editorial and proofreading skills
Effective organisational and planning skills
Motivation, initiative and adaptability
Ability to work effectively in a small team
For further information on this role do not hesitate to email HR@orchard-tx.com
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.