Director – Regulatory Affairs

The incumbent will direct the regulatory team and cross-functional initiatives as part of business team leadership. Focus on strategic thrusts within the organization and develop regulatory strategies for competitive advantage.  The Senior Director/Director Regulatory Affairs will be responsible for building the regulatory strategy and directing a team of five regulatory specialists who are responsible for regulatory over-sight for EPA, FDA, CVM and AFFCO regulated products. 

Qualifications include a BS/MS/PhD in science or related field with 10+ years relevant work experience in Regulatory Affairs. Pet Care Regulatory Affairs experience is a plus. In depth knowledge of AFFCO and or EPA regulations. FDA experience is a plus.

To learn more about this exciting opportunity, please Apply Now.

Anatomic Pathologist

Provide expertise in the areas of veterinary anatomic pathology and histopathology

Responsibilities

• Providing clients with diagnostic evaluation and consultation in the area of anatomic pathology/histopathology, including both microscopic and gross evaluation of surgical biopsy specimens.
• Consulting with clients regarding interpretation of pathology reports and responding to client inquires.
• Consulting with and assisting other pathologists on difficult cases or when his/her expertise is of relevance.
• Maintaining proficiency and developing skills by attending continuing education meetings.
• Meet caseload and turnaround time expectations and be accessible for client consults during regular working hours.
• Provide leadership and direction to laboratory technicians.

Requirements:

• DVM or equivalent degree
• Minimum of 3 years residency training in anatomic pathology
• Board certification or eligibility by the American College of Veterinary Pathologists (or equivalent certifying organization)
• Experience within a diagnostic laboratory is preferred

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Board Certified Veterinary Pathologist

Industry opportunity for a Board Certified Veterinary Pathologist (DACVP) with pharmaceutical research experience.

To learn more and/or apply for this exciting opportunity, please  Apply Now.

Principal Research Scientist

Clinical Research Coordinator

Our client is a contract research organization that provides comprehensive services supporting all facets of the animal health pharmaceutical development for animal health, biotechnology and life science companies and investors. Clinical Research Coordinators are responsible for the planning, execution and completion of good clinical practice and/or good laboratory practice studies.

The Research Coordinator will communicate with and travel to designated study sites to conduct pre-study site evaluations, study initiation, interim monitoring and study close out visits for preclinical and clinical studies. The incumbent will establish rapport with subcontractors and study site personnel to facilitate communication and compliance with all study activities. Reviews the study records, casebooks and Investigator’s notebooks to ensure contents are current and complete including verification of owner consent, existence and maintenance of source documents and inventory of test supplies. Facilitates clarifications, corrections and data query resolution with study sites or data management, subcontractors and assists with responses to quality assurance audits. The incumbent will assist in management of study test article inventories and other related study materials. Depending on qualifications, may assist in the appropriate response to, and documentation of, adverse events. May serve as Project Manager and have oversight of all communications with a client for a specific clinical study. As Project Manager will coordinate the allocation of monitoring and quality control resources to best meet client needs, including scheduling and oversight of Clinical Research Coordinators. Serves as an ambassador for the company to generate new business and new business leads.

Qualifications include DVM or VMD. Good communication skills, good active listening skills. Experienced in GCP trials, 3-5 years of practice experience. Excellent interpersonal skills. Ability to travel 75% of the time. Basic computer skills, valid driver’s license with clean driving record, willingness to travel. Minimum Experience in data management, quality control and/or quality assurance is helpful.

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Associate/Manager – Quality Assurance

Company looking for detail-oriented professional to play important role in completing timely, high quality regulatory documents and submissions, managing and maintaining various compliance systems, and implementing product projects.

The incumbent will review and ensure accuracy of various reports and documents for FDA submissions; manage and maintain regulatory and product development document systems;  track and maintain current state manufacturing and distributor licenses;  manage administrative tasks for bioequivalence studies; maintain product development project timelines and meeting minutes.

Must have at least 2 years experience in a pharmaceutical QA role.

To learn more and/or apply for this opportunity, please  Apply Now.

Director/Manager – Product Development

The incumbent will work with company’s domestic and overseas development partners and contract manufacturers to develop a wide range of pharmaceutical products for companion animals. The incumbent will be accountable for managing these relationships and for the on time delivery of high quality CMC documentation to Regulatory Affairs to support submissions. The incumbent will be self motivated, experienced in working with multiple, concurrent external manufacturing partners and have a thorough understanding of product and process development and cGMP manufacturing environments.

To learn more about this exciting opportunity, please Apply Now.

Senior Clinical Research Coordinator

Our client is a contract research organization that provides comprehensive services supporting all facets of the animal health pharmaceutical development for animal health, biotechnology and life science companies and investors. Clinical Research Coordinators are responsible for the planning, execution and completion of good clinical practice and/or good laboratory practice studies.

The Research Coordinator will communicate with and travel to designated study sites to conduct pre-study site evaluations, study initiation, interim monitoring and study close out visits for preclinical and clinical studies. The incumbent will establish rapport with subcontractors and study site personnel to facilitate communication and compliance with all study activities. Reviews the study records, casebooks and Investigator’s notebooks to ensure contents are current and complete including verification of owner consent, existence and maintenance of source documents and inventory of test supplies. Facilitates clarifications, corrections and data query resolution with study sites or data management, subcontractors and assists with responses to quality assurance audits. The incumbent will assist in management of study test article inventories and other related study materials. Depending on qualifications, may assist in the appropriate response to, and documentation of, adverse events. May serve as Project Manager and have oversight of all communications with a client for a specific clinical study. As Project Manager will coordinate the allocation of monitoring and quality control resources to best meet client needs, including scheduling and oversight of Clinical Research Coordinators. Serves as an ambassador for the company to generate new business and new business leads.

Qualifications include Bachelor’s degree, preferably in a scientific discipline or significant experience in a similar role. An advanced degree (MS, DVM or VMD) is highly desirable. Good communication skills, good active listening skills. Basic computer skills, valid driver’s license with clean driving record, willingness to travel.  Minimum of six years including experience participating and/or managing animal health clinical studies for Senior Research Coordinator role. Experience in data management, quality control and/or quality assurance is helpful.

To learn more about this exciting opportunity, please Apply Now.

Regulatory Compliance Manager

The primary purpose of this role is to provide scientific knowledge and regulatory expertise to our client’s organization. The primary focus of this position is to manage the FIFRA Regulatory Actions and Regulatory Staff to support the sales of our client’s products. Read more

Director, Center for Animal Resources and Education

Our client is a recognized leader in research and education and is among the largest in the nation, with numerous facilities and an extensive variety of research and teaching activities. The incumbent in this position will provide services and expertise to facilitate research and teaching and to ensure the safe, humane and judicious use of animals. The incumbent will serve as Attending Veterinarian and is responsible for administration of the animal care and use program in compliance with state and federal regulations and university policy. The incumbent will develop and implement services, support and standards that facilitate and advance complex and novel research, teaching, and testing; provide for the safe and humane use of animals. Oversee the management and operation of all animal facilities through direct management of those facilities generally associated with behavioral and biomedical use, and indirectly for those generally associated with agricultural use. The incumbent will deliver a residency program.

 Qualifications include a DVM/VMD from an American Veterinary Medical Association accredited College of Veterinary Medicine. License to practice in a state in the United States. Board certification as a Diplomate, American College of Laboratory Medicine. Advanced training and at least 10 years of experience in laboratory animal medicine in a research intensive university environment. At least 5 years of experience in a senior leadership role in a research environment and in an AAALAC accredited program. In addition to a DVM/VMD, a PhD degree and research experience is strongly preferred.   Client is an equal opportunity, affirmative action educator and employer.

To learn more about this exciting opportunity, please Apply Now.

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