Biosciences - Document Management Associate
Pharmaceutical client, Hampshire
Our client is a forward thinking, leading pharmaceutical company who encourages independent thought from their employees. It is essential for candidates to be adaptable^in the workplace and thrive on an evolving and challenging environment. Located within easy reach of major transport links, our client boasts, modern, spacious offices. A free shuttle bus is available to connect with mainline BR and ample free parking is also available.
As a result of an increasing pipeline, I'm looking for an expert in document management to join my clients regulatory publishing team.
This new permanent role with our pharmaceutical client is to support document management compliance within the Pre clinical Biosciences division. The ideal candidate will be familiar with regulatory submissions, compliance issues and be an expert in Documentum.
The key function of this role is to support submission-level documents and study reports with regards to bookmarking, publishing, preparing submission-ready draft and final study reports, to ensure compliance with international regulatory expectations and client guidelines
Additionally you will be responsible for the verification of submission ready documents and the organizing, formatting, hyperlinking, and publishing of submission-ready documents for global submissions (including Nonclinical Overview, Tabulated Summaries, Written Summaries, Study^Reports)
Essential Skills & Qualifications Required
Bachelors degree in a related subject is essential.
Significant experience gained within the pharmaceutical industry
Familiarity with EU and US Submissions, Regulatory and Quality guidelines
Excellent administration and IT Skills
Experience in working with EDMS.
Software Competence Required
Intermediate MS WORD, - Intermediate EXCEL, - Intermediate Powerpoint
Employment Type: Permanent role
Employer: Pharmaceutical company
Hours: Full time
Location: Office Based near M3
Plan Start Date:ASAP
Keywords: Registration, Regulatory Affairs, MAA, CMC, EDMS, GMP, Dossier, Regulatory Agency, Documentum, QA
Assigned Consultant: Kirsty Clark at CSL on 01932 234681
Please^feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they are suited to the role. The role may have been remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We are unable to respond to applicants who are not EU nationals unless they include evidence of right to work in full time employment with their application. Do apply with relevant information on required location or salary/day rate if you are a new candidate.