Regulatory Associate I - Clinical Trials -Cambridge
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 Middlesexon^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 pipelineand are currently very active in recruiting candidates to 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 placetowork. Our client understands that each candidate is not 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!
Work with some of the best in the business!
My client is currently actively seeking a Regulatory Associate to join the Regulatory team on an initial 11monthbasis. Learn from the best as you provide 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 be keen to learn and adapt with ease as you take on tasks ad hoc to assist with the smooth running of the department.Over time, you will develop an in depth understanding of clinical trial labelling as you review and approve labels for IMP product. You will be approachable and have great communication skills which you will use to construct long term professionalrelationships 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.
Software Competence: MS Office, MS Project, DOCUMENTUM
Valid Driving License: Not Required
Working Language(s): English
Requirement for Business Travel: No
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 11 months
Location: UK; Location Office Based in Cambridgeshire
Plan Start Date: 11th June 2012, please do not apply if you are unable to meet this start date.
Contract Benefits: Day Rate inclusive of benefits
MS Office, MS Project, DOCUMENTUM, Registration, Regulatory Affairs, MAA, CMC, Expert Reports, Clinical Trial Applications, CTA, CPMP, Dossier, Regulatory Agency
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 onlyreceive 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.