Theradex (Europe) Ltd – Senior Medical Writer- Oncology Clinical Trials - Remote
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe, and Asia. We can proudly say that Theradex Oncology will be celebrating its 40th Anniversary this September.
Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a liveable disease.
About the Role
Theradex is recruiting for a highly collaborative Senior Medical Writer (Permanent, Full time) with 5+ years’ experience to join our team. If you are a self-starter and want to be part of the full life cycle of the regulatory medical writing process, this opportunity may be for you.
The Senior Medical Writer will be part of the growing team within Theradex and have a client facing, collaborative role with direct involvement with medical monitors and senior leadership.
The primary responsibilities of this position include, but are not limited to, the following:
- Preparation of:
o Initial Investigational New Drug (IND) applications and amendments
o Clinical study protocols and protocol amendments
o Investigator brochures and updates
o Interim and final clinical study reports
o IND annual reports
o Development safety update reports
o Patient informed consent forms
Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents
Serve as a resource for new medical writers
What you Need
- Bachelor’s degree required / Advanced degree preferred
- 5+ years prior experience in a CRO/pharmaceutical environment
- 3+ years prior relevant experience in regulatory Medical Writing (oncology experience preferred)
- Lead writer experience on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, IND applications
- Experience collaborating directly with clients/Sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings
- Proven experience with Fast Track Applications: INDs/BTDRs
- Familiarity with eCTD modules
- Familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
- Ability to work independently, meet deadlines and be results-oriented
- Ability to manage critical issues on multiple projects simultaneously
- Function as a team-player, highly organized, self-motivated, and extremely detail-oriented
- Strong oral and written communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite
What we Offer
We offer a friendly and supportive culture that puts people first. You will be provided with a competitive compensation and benefits package as per country requirements.
This position is open to candidates from the following countries UK, Italy, Sweden, Germany, France, Republic of Ireland.
How to Apply
Please submit your application via our career portal on the link below.
For any queries about this role, please contact: DFernandes@theradex.com