At a Glance
- Tasks: Join us in crafting essential medical documents for groundbreaking cancer therapies.
- Company: Theradex Oncology, a leader in oncology trials with over 40 years of experience.
- Benefits: Competitive pay, supportive culture, and remote work options across the UK, Sweden, Norway, and Denmark.
- Other info: Opportunity to lead projects and mentor new writers in a dynamic team.
- Why this job: Make a real difference in cancer treatment while advancing your career in a collaborative environment.
- Qualifications: 5+ years in medical writing, preferably in oncology, with strong communication skills.
The predicted salary is between 40500 - 49500 £ per year.
Who We Are
Celebrating 40+ Years! Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. 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 very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.
What You'll Do
Theradex is recruiting for a highly collaborative Senior Medical Writer 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.
Remote: UK, Sweden, Norway and Denmark
The primary responsibilities of this position include, but are not limited to, preparation of the following:
- Initial Investigational New Drug (IND) applications and amendments
- Clinical study protocols and protocol amendments
- Investigator's brochures and updates
- Interim and final clinical study reports
- IND annual reports
- Development safety update reports
- 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
Level of Education
Bachelor’s degree required / Advanced degree preferred
Prior Experience
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 at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, IND applications, Informed Consent forms.
Experience working directly with clients/Sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings.
Preferred
Familiarity to eCTD modules
Skills and Competencies
Familiarity with industry principles of drug safety, EU, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology.
Effective knowledge of company and sponsor-specific SOPs.
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 job does not offer company sponsorship. Theradex is an equal opportunity employer.
Job Posting Title Senior Medical Writer employer: Theradex Systems, Inc.
Theradex Systems, Inc. is an excellent employer for those seeking a meaningful career in clinical data management, particularly within the dynamic field of oncology. With a hybrid work model that promotes flexibility and a supportive culture focused on collaboration and compliance, employees benefit from competitive compensation, pension contributions, and private medical insurance. The company also prioritises professional growth, offering opportunities to lead impactful studies while working in a vibrant location like Crawley, West Sussex.
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