Yacht Life Sciences has a vacancy for a Senior Clinical Registry Administrator to work for Janssen Biologics.
As a Senior Clinical Registry Administrator you are a member of the enterprise wide Clinical Registry team and can support pharma, consumer and/or medical devices operating companies with their clinical trial data disclosure obligations. The team, located in the US, Europe and Asia (third party), is responsible for ensuring that accurate, validated and consistent clinical trial data is posted on clinical trial registries worldwide.
As a Clinical Registry Administrator, you:
- Are part of the Bioresearch Quality & Compliance Quality (BRQC) Analytics team
- Will track, keep oversight of submissions, upload and distribute registration records and results
- Will follow up of documents for review/approval requests, documentation.
- Support regional and/or local registries for a determined section of the companies portfolio.
- Perform non-core registries such as EU-PASS or other departmental tasks related to the submissions
- Work closely together will clinical and medical teams, clinical development operations, regulatory affairs, biostats & programming, and/or local operating companies to ensure that the company meets its disclosure requirements and that the data to be disclosed is consistent across the registries and is of high quality and integrity.
- A Bachelor or Master degree in (Bio)medical Science, Bio-pharmaceutical Science, Life Science & Technology or equivalent is required
- >4 years of similar experience in a medium to large scale matrix quality organization (operational quality and/or quality assurance) or equivalent time and experience in a related R&D area (clinical trials, regulatory affairs, data management, data operations and/or statistics)
- Demonstrated competency in accurate work with clinical trial or regulatory data, data management, programming, scripting or data operations
- Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech)
- Knowledge of the pre-clinical and clinical drug development process is beneficial
- Excellent knowledge of English is required
Technology experience and skills:
- Experience with Quality and Compliance systems is preferred
- Proficient in Microsoft Office applications
We are open to candidates with the right background (CTA-GTM/Regulatory Submission experience) and skill-set.
- Ability to support an open, inviting and creative environment
- Strong interpersonal skills with demonstrated history of collaboration across multiple functional areas
- Proactive strategic thinker with strong problem solving skills
Terms of employment:
This concerns a secondment contract via Yacht until December 2023 (extension is possible). Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefits package in line with your seniority and the seniority of the position.
This position is open for freelance/ ZZP as well.
About the company:
Janssen Biologics, part of J&J, is a global biotechnological company that develops, acquires, and commercializes pharmaceutical products and biopharmaceutical therapies.
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.