Theradex is a leading global Contract Research Organisation conducting early- and late-phase oncology trials in the U.S., Europe, and Asia. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. 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 is a solid basis for our operations. Our focus is cancer. We are a full-service CRO that understands the science behind each potential cancer therapy and the challenges of moving therapies from mice to man. Theradex Oncology has designed and managed over 250 early and late-phase oncology trials. Our mission is to ensure that new discoveries in cancer drug development have the best opportunity to benefit mankind, with a vision to improve treatment and make cancer a liveable disease.

We are hiring contractor/freelance Regulatory Country Approval Specialist based in Germany or Austria. As a country approval specialist you will provide local regulatory strategy and advice and you will also manage the preparation, review and coordination of national submissions from time to time when needed (Time and Material contract).

Do you want to be part of our successful oncology clinical trial delivery team where our size and specialty are an advantage? We want to hear from you if you have at least 3+ years of industry experience in a regulatory or similar role in a CRO/pharmaceutical environment in Germany/Austria.

Primary duties and responsibilities include:

• Provide input on National requirements concerning Clinical Trials.

• Provide training on National requirements to other members of the team as required.

• Prepare & submit applications to Radiation Safety authorities, GMO authorities, Biobank, and other relevant authorities.

• Maintaining approvals with local authorities.

• Translation of relevant documents

• Liaising and maintaining good relationships with relevant authorities.

• To stay updated with national requirements.

Level of Education and Prior Experience:

• At least 3 years of industry experience in a regulatory role or similar role

• Prior experience in a CRO/pharmaceutical environment required in Germany/Austria

Experience / Competencies

• Ideally, experience in a study start-up, or experience with, regulatory documents in a clinical setting

• Bachelor’s degree required, preferably in a life science field or equivalent

• Deep knowledge of the Clinical trial regulations in Germany and Austria Clinical Research Legislation

• Experience interacting with Ethics Committees in Germany and Austria.

• Previous experience with submissions to other Local Authorities.

• Previous CRA skills who have done submissions experience.

• Previous submission experience to Radiation Safety Authorities and other national bodies.

• Understanding of ICH-GCP

• Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures

• Strong attention to detail

• Customer focus

• Effective communication and interpersonal skills

• Good organizational and time management skills

• Ability to work in a team or independently as required

• Fluency in German/German-Austria, both written and spoken

This job does not offer company sponsorship

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.

ID: 2023-1289

External Company URL: https://www.theradex.com/