(US-North Carolina-Raleigh/Durham-RTP) This position will be responsible for preparing scientific and regulatory documents, marketing support, and clinical trial project management. REQUIREMENTS: *PhD in life or health sciences and one year clinical research experience OR Bachelor's Degree in life/health sciences and 5 years clinical research experience with a minimum of 4 years monitoring experience *Strong knowledge of regulatory submissions - IND's and NDA's *Strong knowledge of FDA regulations and guidelines *Strong knowledge/understanding of statistical methods and analysis *Strong knowledge of clinical study design and principles and methods of clinical drug development/clinical research in the pharmaceutical industry *Demonstrated leadership skills *Project Management experience *Working knowledge of MS Suite of software *Excellent scientific writing skills *Ability to travel up to 80% during training period (4-6 months) Competitive salary, bonus and exceptional company benefits.
(US-Pennsylvania) SENIOR DIRECTOR/VP OF GLOBAL CQA, King of Prussia, PA, for our client, a leading provider of pharmaceutical care for the elderly providing clinical research services for the pharmaceutical and biotechnology industries in 27 countries worldwide. The Senior Director/VP of Global CQA will establish company policies through SOPs etc. regarding interpretation/implementation of Good Clinical Practice, advise Clinical Research staff regarding GCP compliance and training, establish policies for Global CQA operations; oversee Global CQA functions of consulting, auditing, validation, and SOP administration. S/he will facilitate other departments’ enhancement of their quality of services provided to sponsors, oversee budgets of US and International CQA, oversee development of CQA sections of project proposals and coordinate, host, and facilitate follow-up of audits of the company by sponsors and FDA as well as providing guidance for inspections by other regulatory agencies. S/he will also oversee development and implementation of US and International Master Quality Plans for non-contracted CQA audits and other internal services and represent Global CQA at meetings of the Corporate Executive Committee, other management teams, and other departments, and at external meetings. QUALIFICATIONS The ideal candidate will have a Bachelors degree (Masters preferred) in Life Sciences/Biomedical or equivalent complemented by eight years experience with clinical research/auditing, seven years pharmaceutical/biotech/CRO experience, and five years management experience COMPENSATION Compensation is competitive and includes base salary and a comprehensive benefit package.
(US-Virginia-Richmond) Metabolic Engineering /Protein Engineering An excellent postdoctoral position is immediately available in Dr. Rachel Chen’s laboratory in the newly established Chemical Engineering Department, Virginia Commonwealth University. Located in Richmond, VCU is one of the three major public universities in the Commonwealth of Virginia that have Carnegie Research University designations. The Chemical Engineering Department boasts outstanding faculty members, including an affiliate professor, Nobel Laureate, Dr. John Fenn. Interfacing molecular biology and engineering, and the latest development of microarray technology, our research focuses on Metabolic Engineering and Protein Engineering. The initial contract will be one year, renewable to 2 years or longer. Assistance with visa applications will be provided. Interested candidates with strong background in Biochemical Engineering, Molecular Biology, Microbial Physiology, Protein Chemistry or other related disciplines are encouraged to apply.
