BIOLOGICS CONSULTING GROUP INC

Compensation

Full Description

This posting will close on October 10, 2025. Position Summary: The Consultant is a mid-level role responsible for managing and contributing to the successful execution of client projects, within the Medical Device team and on projects that are complex or of a cross-functional nature. This role involves significant involvement in the development and completion of project deliverables, such as technical reports, research, and U.S. Food and Drug Administration (FDA) regulatory submission support. The Consultant may also assist with managing client relationships, support proposal development, and is accountable for meeting individual financial performance targets. The position requires demonstrated subject matter expertise, strong project management and communication skills, and the ability to work effectively across multiple projects and teams. The Consultant is also expected to engage in ongoing professional development and contribute to knowledge-building within their area of specialization. Biologics Consulting Group, Inc. works with medical device, biologics and pharmaceutical companies to advance patient health. Essential Responsibilities: • Assist in the coordination and management of scientific projects within a single area of technical discipline and also across multiple therapeutic areas. • Contribute to the development of high-quality deliverables, including regulatory documents, technical reports, and literature reviews. • Provide quality control for work authored by junior team members and ensure deliverables meet client expectations and regulatory requirements. • Support and contribute to proposal preparation for new business opportunities. • Manage or support client relationships, including communication and delivery of project milestones. • Collaborate effectively with team members and cross-functionally across multiple concurrent projects. • Manage competing priorities effectively while meeting deadlines and maintaining high-quality work. • Exhibit strong verbal and written communication skills, tailored to scientific and professional audiences. • Maintain responsibility for meeting individual financial performance targets. • Participate in ongoing professional development and expand expertise within a specialized subject area. • Independent use of Quality Management Systems (QMS) software such as Greenlight Guru, Qualio or similar eQMS systems. • Development and submission of regulatory documents including use of eSTAR and eCOPY • The incumbent will lead by example and foster a team environment, ensuring an overall ‘culture of quality’ in the high-quality execution of services provided to clients. Requirements: • Ph.D. in a related scientific discipline from an accredited institution strongly preferred, with at least 3-5 years of relevant industry, consulting, and/or FDA experience. • Alternatively, a master’s degree in related discipline and at least seven years of relevant experience. • Biology, engineering or material sciences or other science related background strongly preferred • Prior consulting experience and/or direct FDA experience or other regulatory interactions strongly preferred. • Proven ability to significantly contribute to scientific projects and work independently. • Familiarity and understanding of ISO 13485 and 21 CFR 820 • Knowledge of biocompatibility and/or tissue/plastics science • Experience with biosurgery devices, plastic and reconstructive surgery devices a plus • Strong technical writing, analytical, and research skills • Knowledge of regulatory pathways and strategy development, including familiarity with alternative approaches to regulatory challenges. • Effective interpersonal communication skills • Ability to manage competing priorities in a dynamic, deadline-driven environment. • Ability to create effective PowerPoint presentations and leverage current software and tools. Key Performance Indicators: • Achievement of billable hours targets • Quality and timeliness of client deliverables • Demonstrated teamwork capabilities • Strong technical writing and documentation skills • Excellent communication skills, both written and verbal. • Strong project management capabilities, including planning, execution, and coordination • Ability to manage time effectively and prioritize across multiple assignments • Developing client management and relationship-building skills Essential Skills: Proficient in Microsoft Office Suite, keyboarding skills, strong documentation skills, math aptitude, diplomacy and leadership skills, professionalism, time management, ability to multi-task, able to work independently as well as collaboratively, and able to maintain confidentiality. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.