Location: Anywhere in Bulgaria
Closing Date: 03 Jan 17
Salary (£): Competitive
Benefits: on application
Our successful and dynamic team in Bulgaria is currently looking to expand. Are you searching for an exciting new role? Do you have any experience in start-up and regulatory affairs? Then this is a fantastic opportunity for you! We are looking to recruit Regulatory and Site Services Specialist 2
CHILTERN International – who we are
Established in the UK in 1982, Chiltern is leading privately owned global CRO with 4200 employees located around the world. Chiltern has extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery. Chiltern is a CRO that starts every project by taking the time to understand each sponsor’s situation. Then we draw on a wide-ranging skill set to craft a customized engagement perfectly matched to those needs from start to finish.
Our successful and dynamic team in Bulgaria is currently looking to expand. Are you searching for an exciting new role? Do you have any experience in start-up and regulatory affairs? Then this is a fantastic opportunity for you! We are looking to recruit Regulatory and Site Services Specialist 2- home based, fix term contract
Duties & Responsibilities:
1. Support the RSS team where applicable with regulatory and ethics submissions subject to resource needs e.g. non-substantial amendment submissions.
2. Assist in the development of Informed Consent Forms, labels and other patient facing material in accordance with country-specific requirements.
3. Coordinate and/or perform the preparation, quality control review, and submission of CTA packages including initial submission, amendments and End of Trial Declarations as well as non-substantial notifications, status reports etc. to the CA and IRB/IECs and to any other country specific authority/body in assigned countries (except FDA).
4. Prepare and respond to Competent Authority (CA) and Ethics Committee (EC)/Institutional review Boards (IRB) and to any other country-specific authority/body after Regulatory Project Lead/Manager approval.
5. Develop and produce metrics and status reports to support the needs of Project Managers, line management, and other senior-level department colleagues.
6. Facilitate/participate in training programs and department meetings.
7. Provide input to Requests For Information (RFIs), Requests surfor Proposals (RFPs) and bid defense presentations as required.
• Bachelor’s degree in life sciences, related discipline or experience in the role.
• Minimum 2 – 4+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
• Experience of the clinical research process and terminology
• Experience using a clinical trial management system
• Experience as a mentor
The successful candidate will be a strong communicator, who has a great eye for detail and excellent organizational skills. You will have the ability to work independently and as a part of a team.
For more extensive information about Chiltern, please visit our web site at www.chiltern.com
For a confidential discussion about this opportunity, please telephone our Internal Recruiter Magda Mirowska on +44 1617900813
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.