(US-Virginia) QA-GCP managers are responsible for coordinating the GCP compliance activities in the department by working with this company's clinical and other related functional team members and contract auditors to assure GCP compliance. QA-GCP managers will assure QA-GCP SOPs are in place, updated and are followed. QA-GCP managers will perform clinical site audits, CRO audits, clinical systems audits, master files audits and clinical study report audits. Oversees work of contractors and, when appropriate, supervise Quality Assurance Associates. Effectively manage organizational resources and work within budget guidelines with respect to project responsibility and QA-GCP/GLP responsibilities. Evaluate significance of audits findings and coordinate the findings responses with companywide departments, CROs and/or clinical investigational sites, as needed. Participate in CRO/vendor qualification audits to support activities for assigned drug development programs. Participate in investigator's meetings by presenting the regulatory compliance responsibilities and plans for sponsor audits of sites. Review clinical documents including protocols, amendments, sample case report forms, and sample Informed Consent Forms for adequacy and compliance. Develop relationships with Sepracor clinical department personnel, CRO quality assurance staff and investigational site staff to assure information relevant to compliance is shared among all involved parties to assure compliance for development programs. Train staff, CRO staff and/or investigational site staff on regulatory requirements, compliance standards and quality initiatives. Requirements: Minimum of Bachelor's degree in sciences (e.g., biology, chemistry, pharmacy) or equivalent. Minimum 5 years (manager) or 8 years (senior manager) experience in the pharmaceutical industry or comparable experience with pharmaceutical industry sponsored clinical research (i.e., as investigational site personnel). GCP compliance experience as an auditor for a minimum of 4 years. Extensive knowledge of GCP regulations and ICH guidelines. Minimum of 5 years (manager) or 8 years (senior manager) of auditing or comparable experience in pharmaceutical development clinical research industry. Excellent communication, organizational, interpersonal and computer skills. Supervisory or management experience. Capable of working in a team environment to generate consensus and resolve conflicts. Willing to travel domestically and internationally (30-50%) Good/excellent knowledge of FDA GCP regulations and ICH Guidelines. Excellent interpersonal, oral communication and report writing skills. Ability to identify compliance issues, communicate issues to others and identify resolutions effectively. Demonstrated management experience. Good organizational and computer skills. Capable of working in a team environment and independently. Willing to travel domestically and possibly internationally (approximately 50%). Ability to manage multiple tasks in a changing environment.
(US-Virginia) One of the fastest growing companies in Virginia, seeks to fill an R&D Scientist position immediately in the general area of nanotechnology related biochemistry / pharmacology for drug development with unique nanomaterials. The successful candidate will be responsible for actively participating in ongoing research projects, understanding funding opportunities, fostering creative ideas, and promoting teamwork in the successful completion of assigned tasks. Some travel and customer interface may be required. Ideal candidates should have a Ph.D. in Pharmacology/Organic Chemistry (nanotechnology focus)/Biochemistry or related field. A strong expertise in biochemistry, drug development, and nanotechnology as well as previous SBIR/Government Grant success in these areas is strongly preferred. Specific R&D areas may include but are not limited to nanotechnology based imaging and therapeutic agents including cancer specific applications, toxicology, biodistribution, efficacy studies, drug design, and nanobiotechnology. Candidates must be able to coordinate and manage lab activities, and be able to work with a multidisciplinary team. A demonstrated ability to actively support efforts to secure R&D funding is strongly desired. Excellent oral and written communication skills are required. Due to contractual obligations, US citizenship is required.
(US-Massachusetts) QA-GCP managers are responsible for coordinating the GCP compliance activities in the department by working with this company's clinical and other related functional team members and contract auditors to assure GCP compliance. QA-GCP managers will assure QA-GCP SOPs are in place, updated and are followed. QA-GCP managers will perform clinical site audits, CRO audits, clinical systems audits, master files audits and clinical study report audits. Oversees work of contractors and, when appropriate, supervise Quality Assurance Associates. Effectively manage organizational resources and work within budget guidelines with respect to project responsibility and QA-GCP/GLP responsibilities. Evaluate significance of audits findings and coordinate the findings responses with companywide departments, CROs and/or clinical investigational sites, as needed. Participate in CRO/vendor qualification audits to support activities for assigned drug development programs. Participate in investigator's meetings by presenting the regulatory compliance responsibilities and plans for sponsor audits of sites. Review clinical documents including protocols, amendments, sample case report forms, and sample Informed Consent Forms for adequacy and compliance. Develop relationships with Sepracor clinical department personnel, CRO quality assurance staff and investigational site staff to assure information relevant to compliance is shared among all involved parties to assure compliance for development programs. Train staff, CRO staff and/or investigational site staff on regulatory requirements, compliance standards and quality initiatives. Requirements: Minimum of Bachelor's degree in sciences (e.g., biology, chemistry, pharmacy) or equivalent. Minimum 5 years (manager) or 8 years (senior manager) experience in the pharmaceutical industry or comparable experience with pharmaceutical industry sponsored clinical research (i.e., as investigational site personnel). GCP compliance experience as an auditor for a minimum of 4 years. Extensive knowledge of GCP regulations and ICH guidelines. Minimum of 5 years (manager) or 8 years (senior manager) of auditing or comparable experience in pharmaceutical development clinical research industry. Excellent communication, organizational, interpersonal and computer skills. Supervisory or management experience. Capable of working in a team environment to generate consensus and resolve conflicts. Willing to travel domestically and internationally (30-50%) Good/excellent knowledge of FDA GCP regulations and ICH Guidelines. Excellent interpersonal, oral communication and report writing skills. Ability to identify compliance issues, communicate issues to others and identify resolutions effectively. Demonstrated management experience. Good organizational and computer skills. Capable of working in a team environment and independently. Willing to travel domestically and possibly internationally (approximately 50%). Ability to manage multiple tasks in a changing environment.
(Canada-Quebec-Montreal) Responsible for developing strategies to ensure rapid approval of products, managing the preparation of regulatory submissions to aggressive targets and the rapid approval of applications to support clinical research. You also ensure regulatory and corporate compliance for assigned products, maintain regular contact with global function groups and liase with Health Canada contacts on assigned submission and project related issues. Sound working knowledge of the Canadian Food and Drugs Regulation, solid understanding of drug development and commercialization process Substantial growth -In just a short time the company has emerged as one of the leading pharmaceutical companies. Since 1996 revenues have grown at an annual growth of 188% and their profitablity and has ranked them among Canada's most profitable public pharmaceutical companies. The company is made up of talented people who are committed to bringing new products to the market, building shareholder value and making a difference to Canadian Patients.
