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Job Details

Regulatory and Site Services Specialist II

Company: Chiltern
Location: Office based in Slough or Edinburgh with the potential for 2 days per week home working
Reference: JT-900085
Closing Date: 20 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Regulatory and Sites Services Specialist. Permanent opportunity with global CRO. We are looking to recruit Regulatory and Site Services Specialist 2 - office based in Slough or Edinburgh with the potential for 2 days per week working from home. Successful candidates will have the opportunity to be part of a growing company with a strong brand and professional employees that care about the work they are involved in.

Requirements:

Job Background

Duties & Responsibilities:

  • Support the RSS team where applicable with regulatory and ethics submissions subject to resource needs e.g. non-substantial amendment submissions.
  • Assist in the development of Informed Consent Forms, labels and other patient facing material in accordance with country-specific requirements.
  • 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).
  • 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.
  • Develop and produce metrics and status reports to support the needs of Project Managers, line management, and other senior-level department colleagues.
  • Facilitate/participate in training programs and department meetings.
  • Provide input to Requests For Information (RFIs), Requests for Proposals (RFPs) and bid defence presentations as required.

 Requirements:

  • 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
  • Candidate is expected to be well experienced in competent authority submissions (at least in UK and Ireland, but experience in the Nordic countries would be of advantage) and ethics committee submissions (UK and Ireland).
  • 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.

Chiltern, a global contract research organization, is a leading provider of clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,300, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services using a collaborative approach for more efficient clinical trials. Visit Chiltern.com to learn more about how Chiltern is Designed Around You®.

For more extensive information about Chiltern, please visit our web site at www.chiltern.com

Additional Information:

  • For a confidential discussion about this opportunity, please phone 01753 216725
  • To apply, please send your CV to julia.thomson@chiltern.com
  • Please note that if your experience does not mirror that of our requirements for this role you may not receive a response
  • No agency submissions will be considered


Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

Competitive

Position Type

Permanent
Full Time

Contact

Email Julia Thomson - Julia.Thomson@chiltern.com
+44 (0) 1753 216 725

Apply for this job: Regulatory and Site Services Specialist II

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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