Document Manager, Pre- Clinical/Biosciences ca. £18/hr
Rolling Contract with major Pharmaceutical Employer based in Hampshire
My client is in urgent need of assistance and we're keen to help. If you are an SME in the use of Adobe, MS Word or Documentum and you're keen to specialise in document management in biosciences then this long term assignment with a leading company could suit your down to the ground. I'm not looking for a scientist but someone with the attention to detail and knowledge in drug development who can spot errors, ensure documents are formatted and well presented and contribute to template creation and compliance in documentation to a house style which can readily be presented to regulators. If you have worked in biosciences and document manipulation using WORD is your expertise then we'd like to hear from you. This is not a backroom job… you'll be supporting senior stakeholders in their work and eligible for rewards when submissions are successful at first pass. Tasks? Read on..
Provides document management support for submission-level documents and pre-clinical study reports including:
bookmarking, publishing, preparing submission-ready draft and final study reports, to ensure compliance with international regulatory expectations and Global Style Guidelines
verification of submission readiness of submission documents (including CRO reports made submission ready at CRO)
supporting incorporation of CRO study reports into electronic document systems for submissions
organizing, formatting, hyperlinking, and publishing submission-ready documents for global submissions (including Nonclinical Overview, Tabulated Summaries, Written Summaries, Study Reports)
performing qualitychecking of submission documentation
requesting, compiling and verifying published literature references
making submission ready Nonclinical responses to queries from, and annual updates for, regulatory agencies worldwide
maintaining templates and^process documents
maintaining an awareness of regulatory authority requirements on technical/format aspects of submissions globally
Liaises with biosciences scientists and staff, external vendors and Global Regulatory Affairs colleagues to facilitate submission ready document content and process.
Serves as an information resource and point of contact, provides user training and support for new and existing document management tools, and provides continuity of experience and history of practice for document management and submissions process.
Essential Skills & Qualification
Pharmaceutical experience preferably in a regulatory environment
Familiarity with scientific terminology ideally
Experience working with information management, document management technology and publishing systems
Expertise with the contents/formatting of regulatory documents and knowledge of international submission requirements, highly desirable
Expert in working with MS Word, MS Project, MS Excel and MS PowerPoint
Publishing expertise using Adobe and Documentum
Effective oral and written communication
Demonstrated skill in communicating and partnering effectively across business groups
Keen attention to detail
Competency in managingwork schedules, priorities, and deadlines personally and as a team member
Must be customer orientated with a good awareness of customer expectations
Ability to manage multiple projects simultaneously and deal with the pressure of quickly changing priorities
Organized self starter who is able to anticipate departmental needs
Valid Driving License: Not Required
Working Language(s): English
Requirement for Business Travel: Seldom
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 11 months/12 Months
Location: UK Hampshire
Plan Start Date: Urgent demand sooner the better..
Contract Benefits: Salary plus benefits or Day Rate
Company Pension, Life Insurance, Bonus, Free gym, Free Bus, Childcare Vouchers.
MS Office, Adobe, DOCUMENTUM, MS Excel, document management, document publishing,
Assigned Consultant: Naida Naidoo at CSL Recruitment on 01932 228 928.
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.