Electronic Submission Specialist
ProClinical is advertising a vacancy for an Electronic Submission Specialist with a major biotechnology company with an extensive presence in the oncology and immunology fields. The organisation's extensive pipeline and commercial portfolio make this a very attractive position for a driven and hard-working incumbent who wishes to develop their career within a prestigious company. This position will be with their team in Uxbridge.
- Supporting Global Regulatory Operations Leads in the coordination, preparation, and submission of all INDS/NDAs/MAAs & 510Ks and life cycle management in eCTD as well as paper and NeeS formats.
- Creating, assembling, publishing, and verifying both major and routine regulatory dossier submissions, including IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc.
- Maintaining of all Regulatory and Health Authority submission archiving within specified time frames.
- Verifying regulated electronic documents via workflows within Celgene's electronic document management system.
- Adhering to required submission timelines, health authority publishing specifications, and internal working practices.
- Liaising with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide.
- Working with regulatory document authors to achieve resolution and ensuring that documents comply with regulatory and company guidance/template specifications.
- Closely interacting with authoring community to track availability of deliverables.
- Maintaining working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
Skills and Requirements:
- A BA/BS degree, or equivalent experience.
- 2 years of pharmaceutical industry experience, specifically in Regulatory Operations.
- Demonstrable experience with compiling eCTD submissions in a publishing tool (eg, eCTDXPress, eCTDManager, ViewPoint, etc).
- Technical knowledge of electronic publishing systems/document management systems and software.
- Knowledge of IND, NDA, MAA, CTD requirements and guidelines, in both paper and electronic formats.
- Fluency in English, in both a written and verbal capacity.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solving problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Highly Competitive Salary
San Francisco, California
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