Senior Medical Writer

Theradex Systems, Inc.; United Kingdom; Remote; GBP 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Medical Writer to join their dedicated team. This role involves preparing essential regulatory documents, including IND applications and clinical study protocols, while collaborating closely with various stakeholders. The ideal candidate will bring over 5 years of experience in a CRO or pharmaceutical setting, particularly in oncology. This innovative firm values a supportive culture and offers competitive compensation, making it an exciting opportunity for those passionate about advancing cancer treatment through meticulous medical writing. If you're ready to make a meaningful impact, this position is for you.

Qualifications

• 5+ years in CRO/pharmaceutical environment with regulatory Medical Writing experience.
• Lead writer on Clinical Study Protocols, Reports, and IND applications.

Responsibilities

• Prepare IND applications, clinical study protocols, and reports.
• Provide guidance to in-house units and support new medical writers.

Skills

Medical Writing

Regulatory Guidelines

Clinical Trial Methodology

Drug Safety Principles

Communication Skills

Project Management

Education

Bachelor’s Degree

Advanced Degree

Tools

MS Office Suite

eCTD Modules

Job description

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, Italy, Sweden, France, Spain

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
• Familiarity with 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.