Electronic Submission Specialist
This vacancy has now expired. Please see similar roles below...
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.
Job Responsibilities:
- 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.
To Apply:
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.
#LI-116788626_PD1
Related jobs
Highly Competitive Salary
Lexington, USA
Proclinical is seeking a dedicated Project Manager to lead IT projects within business applications and IT infrastructure. This is a contract position located in Lexington, MA.
Highly Competitive Salary
Indianapolis, USA
Proclinical is seeking a dedicated and innovative Electrical Engineer to join our Engineering Operations Team. This is a permanent position located in Indianapolis, IN.
Highly Competitive Salary
New Haven, USA
Proclinical is actively seeking an Upstream Associate Scientist. This is a contract position located in New Haven, CT.
Highly Competitive Salary
Boston, USA
Proclinical Staffing is seeking a Senior Director, of Antibody Bioconjugate Discovery to join an innovative biotech developing next generation neurogenetic medicines.
Highly Competitive Salary
Leeds, England
Proclinical is seeking a dedicated Clinical Statistical Programmer with a focus on Oncology. This is a remote permanent position.
€64000 - €98000 per annum + Highly Competitive Salary
Mainz (55131), Germany
Proclinical is seeking a dedicated and proactive Manager for Biomarker Operations. This is a permanent position located in Mainz, Germany.
Highly Competitive Salary
Leeds, England
Proclinical is actively seeking a Senior Regulatory Consultant. This is a remote contract position.
Highly Competitive Salary
Leeds, England
Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.
Highly Competitive
Basel, Schweiz
Proclinical sucht einen Backend-Entwickler/DevOps für unsere offene eHealth-Datenplattform.
Highly Competitive
Koblenz, Germany
Proclinical ist auf der Suche nach einem engagierten und qualifizierten Techniker für Sauerstoffproduktionsanlagen.