Biologics Consulting seeks highly talented Senior Clinical Consultants with considerable experience in clinical product development. Candidates must be able to provide high-quality clinical, scientific, and regulatory support to biologics, drugs and device manufacturers, government and non-government organizations, and academic investigators at all stages of clinical development. The Senior Clinical Consultant must hold the level of training and experience required to function as an independent consultant who will work with clients to provide consulting needs related to specific tasks based on an understanding of FDA regulatory requirements. Support includes the preparation, review and management of CBER, CDER and CDRH regulatory applications.
Qualifications: This position requires an MD degree in the clinical discipline of practice, a minimum of 10 years regulated product experience within FDA or industry, and recognition as an expert in the clinical discipline of training.
Skills: Proficient in Microsoft Office Suite, keyboard skills, oral and written communications skills, strong documentation skills, math aptitude, diplomacy, professionalism, organization, time management, ability to multi-task, able to work unsupervised, and able to maintain confidentiality.
This is a full-time, salary, plus performance based bonus position.
If you have the background that qualifies you for a career at Biologics Consulting, please send your curriculum vitae to the link below.
Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-five years since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients internationally to address nonclinical, clinical, product development and manufacturing, and regulatory compliance challenges.
The cornerstone of this success is found in our team of consultants and professional services staff, comprising subject-matter experts with decades of industry and/or FDA experience. Biologics Consulting offers a great work environment, as well as a highly competitive salary and benefit package, including healthcare, 401k, and ESOP plans.
Biologics Consulting is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/reassignment, citizenship, pregnancy or maternity, veteran status, or any other status protected by applicable national, federal, state or local law.