Introduction
My client is a leading Fortune 500, Biotechnology Company. With headquarters in the USA, my client employs over 500 staff in their UK offices, located in Cambridge and Middlesex on both a permanent and contract basis.
A market leader, my client strives to develop products that change people's lives and in the last 30 years have transformed the management of anaemia, inflammation, and cancer. They have a thriving pipeline and are currently very active in recruiting candidatesto join the team on a contract basis.
Both UK sites are easily reachable by mainline BR and have excellent road links with ample free car parking.
My client knows they offer a great place to work. Our client understands that each candidate isnot the same, and no two roles are either. That's why they permit up to two days working from home per week depending on the role. Moreover, it's a place where you will be more than a contractor- you will be one of the team, and that even means an early Friday finish!
Job Summary
Work with some of the best in the business!
My client is currently actively seeking an International Submissions Publisher to join the Regulatory team on an initial 6 month basis. Learn from the best as youprovide support to members of the team to ensure that regulatory documentation is of the highest possible standard. To do this you will have a real eye for detail as you will be quality checking regulatory documents, including CTAs, MAAs, Variations, Renewals and Extensions prior to their submission to the relevant competent authority. You will also be responsible for the compilation and publishing of dossiers, tracking electronic and paper media and troubleshooting as needed.
You will be keen to learn and adapt with ease as you take on tasks ad hoc to assist with the smooth running of the department. You will be approachable and have great communication skills which you will use to construct long term professional relationships with colleagues and competent authorities alike.
Excellent IT and general administration skills are a must for this post. You will be responsible for a level of electronic filing and archiving, so experience with industry specific systems such as Documentum^and Insight Publisher, would definitely prove advantageous.
Essential Skills & Qualification
Although you must be able to work under direction, a conscientious approach to tasks is essential for this post and you should have a high level of autonomy. Prior experience of working within Submissions Publishing is essential.
Supplementary Requirements:
Software Competence: MS Office, Insight Publisher, DOCUMENTUM
Valid Driving License: Not Required
Working Language(s): English
Requirement for Business Travel: No
Flexible Working Hours: To be confirmed
Employment Information:
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 6 Months
Location: UK; Office Based in Cambridgeshire
Plan Start Date: 2nd July 2012, please do not apply if you are unable to meet this start date.
Contract Benefits: Day Rate inclusive of benefits
Keywords:
MS Office, Insight, Publisher, DOCUMENTUM, Regulatory Affairs, Dossier, Regulatory Agency, Publishing, Submissions EDMS
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.