Yacht Life Sciences has a vacancy for a Clinical Registry Specialist to work for Janssen Biologics.
As a Clinical Registry Specialist 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 Specialist, you:
- Are part of the Bioresearch Quality & Compliance Quality (BRQC) Analytics team.
- Oversee and support regional and/or local registries for a determined section of the companies portfolio.
- Are Subject Matter Expert with regards to clinical trial disclosure requirements.
- Ensure that data quality and compliance requirements for all registries in your portfolio are met.
- 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.
- Monitor compliance of registration and results disclosures.
- Work with vendors to ensure that patients can be referred from registries to participating trial sites, as assigned.
- Keep oversight of intelligence on disclosure requirements worldwide, as assigned.
- Advise company teams with regards to registry compliance and registry-related questions.
- Support BRQC and cross-pharma/cross-segment initiatives, meetings etc. as assigned by the BRQC leadership.
- A Bachelor or Master degree in (Bio)medical Science, Bio-pharmaceutical Science, Life Science & Technology or equivalent is required
- A minimum of 3 years of 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) is preferred
- Demonstrated competency in accurate work with clinical trial or regulatory data, data management, programming, scripting or data operations
- Successful global collaborations and partnerships in a globally diverse environment
- Knowledge of procedural and records management requirements in a regulated industry is beneficial.
- Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech) is required
- Prior pharmaceutical and quality/compliance related experience is preferred
- 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.
You must be strong multitasker, used to a complex, non-standard work environment whilst maintaining highest admin record standards for 'reproducibility' of trials.
- Strong personal leadership with demonstrated competency interfacing with other team members
- Strong networking and relationship building skills
- Ability to support an open, inviting and creative environment
- Ability to embrace generational differences
- Experience working with multidisciplinary and cross functional leaders from IT, R&D, Medical Safety, Regulatory and Quality functions
- Strong interpersonal skills with demonstrated history of collaboration across multiple functional areas
- Proactive strategic thinker with strong problem solving skills
- Strong conflict management/negotiation skills
Terms of employment:
This concerns a secondment contract via Yacht for 1 year. 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.
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.