March 15, 2011 -- International Contract Research Organisation, ClinTec International, has further strengthened its regulatory affairs capability with the recent promotion of Dr Stuart Grant into the newly created role of Associate Director of Regulatory Affairs & Medical Writing.
Based at ClinTec’s global headquarters in Glasgow, UK, Stuart joined ClinTec in 2010 as a Senior Manager of Medical Writing and Regulatory Affairs with more than 9 years industry experience. Stuart has a PhD in Physiology & Pharmacology and worked previously as a pharmacology researcher, Medical Writer, and more recently as a Regulatory Affairs Consultant at a global CRO where he was responsible for managing Phase I–IV regulatory submissions and study start-up activities. His experience covers several therapeutic and research areas including cardiovascular, respiratory, psychiatry, pharmacokinetics and medical devices.
Since joining ClinTec, Stuart has developed and initiated several Regulatory and Medical Writing processes. His work in Regulatory Affairs has spanned clinical trial application oversight, orphan drug applications, medical device regulations, therapeutic area consulting and clinical development planning. In addition, Stuart’s regulatory oversight has covered several diverse geographical regions including Europe, The Middle East and North Africa, Asia and Latin America. In the Medical Writing department, Stuart has been responsible for developing and finalising protocols, reviewing documents written by his team and developing the SOP suite. In addition to Regulatory and Medical Writing support, Stuart provides daily advice to ClinTec’s Clinical Operations, Costings & Proposals and Business Development departments.
Commenting on his promotion and new responsibilities within the company, Stuart stated “I’m delighted to be given this opportunity within ClinTec. The company is continuing to expand into new geographical regions and pharmaceutical sectors which inevitably require us to adapt our processes to satisfy the various regulatory requirements. I’m excited to be heading these departments and look forward to the challenges and opportunities that our continuing growth will bring in these areas.”
Stuart has demonstrated great ability and enthusiasm in leading Regulatory and Medical Writing initiatives since joining ClinTec and is a member of The Organisation of Professionals in Regulatory Affairs (TOPRA), the European Medical Writers Association (EMWA) and the Institute of Clinical Research (ICR). Stuart is also a member of TOPRA’s Clinical Trials Special Interest Network. In addition, Stuart is also the educational head of ClinTec’s Academy of Clinical Research Excellence (ACRE) and has been working with local universities to develop this training initiative.
About ClinTec International
ClinTec International is a global contract clinical research organisation, established in 1997 by Dr Rabinder Buttar, the company’s President and CEO. ClinTec International has a presence in over 40 developed and emerging countries, covering Western Europe, the US, Central & Eastern Europe, the Middle East and North Africa, Sub-Saharan and South Africa, Latin America, India and the Asia/Pacific region.
In addition to ClinTec International’s vast expertise in oncology, the organisation has also conducted over 400 clinical trials in other therapeutic areas including anti-infectives, cardiology, dermatology, gastroenterology, neurology, respiratory medicine and rheumatology. ClinTec International excels in conducting clinical studies in diverse geographical locations, supported by a team of world-class project managers and clinical research associates. ClinTec International’s ‘fast, flexible and focused’ approach to clinical research ensures an added advantage to the drug development process. The organisation’s range of services includes Clinical Monitoring and Project Management, Regulatory Affairs, Medical Writing, Data Management and Biostatistics, Global Clinical Resourcing, Quality Assurance, Drug Development Consultancy and Clinical Training courses.
For further information please contact:
Bobby Bal, Senior Director Corporate Development, ClinTec International Headquarters: +44 (0) 141 226 1120 or bbal@clintec.com
For more information about ClinTec, please visit www.clintec.com
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