Manager - Document Management - Pre clinical biosciences.
Hampshire based pharmaceutical company - Permanent role.
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 our clients regulatory publishing team. This is a superb role where you can work to maintain submission plans that align with major submission milestones. You will manage global dossier submission activities and have ownership of assisting in the development of biosciences process improvements and their implementation. A management level^role that you can really 'make your own'!
Our perfect candidate will take pride in a job well done, show the intellect and interest to establish robust QC systems. The successful candidate will have a solid understanding of the non clinical functions of pharmaceutical drug development and will have substantial experience of working in the pharmaceutical industry with cross functional teams
Key Skills: Drug Development, Regulatory Submissions, Publisher, eCTD, ISI Publishing Suite, Documentum, global liaison, EU registration, NeeS, eDMS
Assist in the planning, review and delivery of regulatory submissions to global health authorities.
Importing, maintaining and archiving all regulatory documentation and submissions within EDMS.
Project management of submission plans
Contribute to process and standards
Essential Skills & Qualification
Bachelor's degree or relevant equivalent experience.
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
Experience with document management technology and electronic publishing software.
Experience in drug development and knowledge of regulatory submission content and formats.
Knowledge of EU Regulatory & document management (eDMS) requirements relating to pharmaceuticals.
Proficiency working with Windows-based desktop productivity applications including Adobe Acrobat technology
Must have the ability to interpret regulatory documents.
Must have strong document organizational skills.
Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
Working knowledge of the CTD structure for drug submissions
Ability to perform document linking and book marking of submission components
Working Language(s): English
Employer: Pharmaceutical Company
Employment Type: Permanent role
Hours: Full time
Location: Office Based access near M3/M4 West London, Hampshire, Wiltshire, Middlesex
Benefits: Pension, Life Cover, Bonus, Free gym, on site restaurant, Free Shuttle Bus
MS Office, MS Project, Zinc, INFORM, IMPACT, DOCUMENTUM, Adobe, Registration, Regulatory Affairs, MAA, CMC, Expert Reports, Clinical Trial Applications, CTA, CPMP, Dossier, Regulatory Agency, Publishing, Publisher, submissions associate, submissions manager, document management
Assigned Consultant: Kirsty Clark at CSL Recruitment on 01932 234 681
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 demonstrate the skills the role requires in their application. The role may be remarketed; if^you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary^information on required location, notice period and expected salary/day rate if you are a new candidate.