Technical Editor II - Pharmaceutical Company - Hampshire
Since our client's formation just over 25 years ago, they have become one of the world's leading specialty biopharmaceutical companies, but despite their growth, they remain^true to the purpose that inspired them from their early days to help people with life-altering conditions to lead better lives
Work with some of the best in the business!
The Technical Editor will be required to edit, word process, and perform quality control checks of clinical documents. This role will also require the Technical Editor to play an integral part of the document finalisation process and proofread and verify data content and formatting for clinical documents^in accordance with company SOPs and processes to ensure documents meet required standards.
Our client's strategic goal is to become the most valuable specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Our clients focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Our client in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Our clients believe that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will continue to deliver strong results.
Edit, word process, and perform quality control (QC) checks of CDO&B documents intended for submission to regulatory^agencies.
Play an Integral part of the document finalization process, wherein adherence to timelines and awareness of criticality are essential elements of the role
Be responsible for delivering quality reviews to document authors across all document types (e.g. Clinical Study Reports, Protocols, Investigator Brochures) in accordance with Our clients SOPs, company defined templates, Our clients Style Guide and existing QC processes
Be responsible for ensuring documents under the control ofthe Technical Editing team, are securely maintained and version controlled to maintain the integrity of documents in accordance with Our clients SOPs and processes
Assist document authors where applicable with the review and approval process
Workwith authors to manage timelines dependant on the complexity of the document and its intended delivery date
Education & Experience Requirements
Bachelors degree or equivalent experience, ideally in the pharmaceutical industry within a ClinicalR&Dor Regulatory function
Previous hands-on experience with Clinical/Regulatory submission documents covering Phase 1 through Phase 4
Proven experience in a Technical Editing or similar role
Software Competence:MSOffice, MS Project, Zinc, DOCUMENTUM
Valid Driving License: Not Required
Working Language(s): English
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Location: UK; Hampshire
Plan Start^Date:1st July 2012,
Company Pension, Company Car, Car Allowance, Life Insurance, Private Healthcare, Dental Care, Flexible Package Plan, Stock Options/Purchase Plan, Bonus, Free gym, Free Bus, Childcare Vouchers. Relocation Assistance.
MS Office,Clinical R&D, CTM, GCP, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Essential Documents, GCP, SOPs, Compliance, Training, REC,Research Ethics. R&D, Quality Control, QC, Registration, Regulatory Affairs,, Expert Reports, PV, Drug Safety, Medical Writing
Assigned Consultant: Matthew Pike at CSL Recruitment on 01932 234685
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.