*****Very urgent requirement for a Regulatory Publishing Expert-LONG TERM Contract now open*****
I'm looking for an expert in document management to join my clients regulatory publishing team. This is a superb role where you can work with internal^stakeholders, vendors and peers to ensure our client's record of filings to regulatory agencies is above reproach and second to none. Our perfect candidate will take pride in a job well done, show the intellect and interest to proof and assess content for mistakes and inconsistency and be able to make a contribution to the success by active participation and dialogue alongside the core role. We can only consider experts who are ready to help vendors ensure compliance and individuals with the drive and passion to ensure best practice by daily questioning of process and efficiency. For the right person this is a secure long term employment option with one of the leading pharmaceutical companies.
Key Skills: Drug Development, Regulatory Submissions, Publisher, eCTD, ISI Publishing Suite, Documentum, global liaison, EU registration, NeeS
Planning, compiling, publishing, review and delivery of regulatory submissions to global health authorities.
Importing, maintaining^and archiving all regulatory documentation and submissions within EDMS.
Review of documents to ensure compliance with submission ready standards guidelines.
Project management of delivery of submissions to regulatory agencies.
Coordinates receipt and review of all necessary global regulatory information for in-licensed products to ensure submission information is added to the repository.
Contribute to process and standards
Quality checking of submission deliverables to client's 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 & Publishing requirements relating to pharmaceuticals.
Must have^eCTD /NeeS Experience
Proficiency working with Windows-based desktop productivity applications including Adobe Acrobat technology
Former publishing experience ISI Publishing Suite
Must have the ability to analyse and 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 via an Agency
Employment Type: Agency Contract
Hours: Full time
Contract Term: 11 months+
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, Documentum, Publishing, Publisher, submissions associate, submissions manager,
Assigned Consultant: Matthew Pike at CSL Recruitment on 01932 234 685
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.