Senior Medical Writer – Theradex Oncology, European Union, Remote
4.6.2023https://www.linkedin.com/jobs/view/3213569986
About the job
Sr Medical Writer – Oncology – Remote/Home Based – based in UK, Italy, France, Republic of Ireland and Sweden.
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.
Theradex is recruiting for a highly collaborative Senior Medical Writer with 5+ years of relevant experience to join our team. If you are a self-starter and want to be part of the full life-cycle of the medical writing process, this opportunity may be for you.
The primary responsibilities of this position include, but are not limited to, the following:
- Preparation of:
- Initial Investigational New Drug (IND) applications and amendments
- Clinical study protocols and protocol amendments
- Investigator brochures and updates
- Interim and final clinical study reports
- IND annual reports
- 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
Level of Education
- Bachelor’s degree required / Advanced degree preferred
Prior Experience
- 5+ years prior relevant experience in a CRO/pharmaceutical environment.
Skills And Competencies
- Familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
- Effective knowledge of company and sponsor-specific SOPs
- Ability to 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. We provide a competitive compensation and benefits package including 6% pension contribution, private medical insurance, sick pay and income protection insurance, life assurance and eyecare voucher scheme.
This Job Does Not Offer Company Sponsorship
Theradex is an equal opportunity employer.