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- Aufgaben: Join us as a Regulatory and Start Up Specialist, ensuring timely site activation for clinical trials.
- Arbeitgeber: Precision for Medicine combines tech and expertise to revolutionize life sciences and patient therapies.
- Mitarbeitervorteile: Enjoy fully remote work options and a culture that values your contributions and ideas.
- Warum dieser Job: Be part of a mission-driven team impacting cancer research and improving patient outcomes.
- Gewünschte Qualifikationen: Bachelor’s in life sciences or related field; 1+ year in regulatory roles, especially in DACH region.
- Andere Informationen: Fluency in English and local language required; strong communication skills are a must.
Das voraussichtliche Gehalt liegt zwischen 36000 - 60000 € pro Jahr.
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.
As our organisation continues to grow we are hiring a Regulatory and Start Up Specialist to join our team in Germany . This position can be offered fully home based.
Essential functions of the job include but are not limited to:
- Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
- Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
- Interaction with CA/EC for study purposes and handling responses to the CA/EC.
- Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership informed.
- Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
- Partner with the assigned site CRA to ensure alignment in communication and secure site.
- Review and manage collection of essential documents required for site activation/IMP release.
- Customize country/site specific Patient Information Sheet and Informed Consent Form.
- Responsible for/facilitates the translation and co-ordination of translations for documents.
- Maintain communication with other key functions participating to country start up, e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
- Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
- When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
- May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
- Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
- Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF.
- May support the clinical team performing Pre-Study Site Visits.
Experience /Qualifications
Minimum Required:
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
- Regulatory/ SU experience in covering DACH region (Germany, Austria, Switzerland).
Other Required:
- Strong communication and organizational skills.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Fluency in English and for non-English speaking countries the local language of country where position is based.
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
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Regulatory and Start Up Specialist Arbeitgeber: Precision Medicine Group
Kontaktperson:
Precision Medicine Group HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Regulatory and Start Up Specialist
✨Tip Number 1
Familiarize yourself with the specific regulations and guidelines for clinical trials in the DACH region. Understanding local laws will not only help you in your role but also demonstrate your commitment to compliance during the interview process.
✨Tip Number 2
Network with professionals in the regulatory field, especially those who have experience in CROs or the pharmaceutical industry. Engaging with others in the industry can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and technologies in clinical trial management. Being knowledgeable about advancements in data sciences and operational efficiencies can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss specific examples of how you've successfully managed site activation processes in the past. Highlighting your problem-solving skills and ability to mitigate risks will resonate well with the hiring team.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Regulatory and Start Up Specialist
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory and Start Up Specialist position. Understand the essential functions and qualifications required, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in regulatory affairs or start-up roles, especially within the DACH region. Provide specific examples of your past work that align with the responsibilities mentioned in the job description.
Showcase Communication Skills: Since strong communication skills are essential for this role, include examples in your application that demonstrate your ability to interact with various stakeholders, such as Competent Authorities and Ethics Committees.
Tailor Your Documents: Customize your CV and cover letter to reflect the language and terminology used in the job description. This shows that you have a clear understanding of the role and its requirements, making your application stand out.
Wie du dich auf ein Vorstellungsgespräch bei Precision Medicine Group vorbereitest
✨Understand Regulatory Requirements
Make sure you have a solid grasp of the local clinical trial laws and regulations, especially those relevant to the DACH region. Be prepared to discuss how you would ensure compliance with these regulations in your role.
✨Showcase Your Communication Skills
Since strong communication is essential for this position, think of examples from your past experiences where you effectively communicated with regulatory authorities or project teams. Highlight your ability to keep all stakeholders informed.
✨Demonstrate Organizational Abilities
Prepare to discuss how you manage multiple tasks and deadlines. Share specific tools or methods you use to maintain project plans and trackers, ensuring timely site activation and submission processes.
✨Familiarize Yourself with Clinical Trial Processes
Brush up on the clinical trial application process, including the preparation of submission dossiers and interaction with Competent Authorities and Ethics Committees. Being able to articulate this knowledge will show your readiness for the role.
