Position Summary:
The Senior Consultant is a mid-to-senior level role responsible for leading complex scientific and U.S. Food and Drug Administration (FDA) regulatory consulting projects, managing client relationships, and contributing to business development activities. The position requires the ability to consult independently, provide scientific and strategic oversight on client work, and mentor junior staff. The Senior Consultant contributes directly to client deliverables while also ensuring quality and consistency in project execution. This role plays a key part in strengthening client partnerships, expanding existing accounts, and supporting organizational growth through thought leadership, professional development, and the development of junior team members. The current position is specifically for a Senior Consultant with a deep expertise in digital health within the device team.
Biologics Consulting Group, Inc. works with medical device, biologics and pharmaceutical companies to advance patient health.
Responsibilities:
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Serve as the senior project leader or project support, as needed for client delivery of project work.
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As senior project leader is accountable for quality and delivery of client work while providing direct consultation to advise them on best approaches that will effectively advance product development efforts including ongoing support from early development through clinical stages and commercialization.
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Communicate submission requirements to clients and others for software and cybersecurity, both for devices with embedded software (software in medical devices [SiMD] and software as a medical device (SaMD)
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Contribute to the development of high-quality deliverables, including regulatory documents, technical reports, and literature reviews.
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Provide quality control for work authored by junior team members and ensure deliverables meet client and regulatory expectations.
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Delegate tasks appropriately across junior team members to optimize workflow and promote development of junior staff.
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Independently manage client relationships and act as a key point of contact for project execution and issue resolution for projects on which the senior project leader role is held.
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Actively manage digital health submissions including ability to independently author software and cybersecurity sections for submission.
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Communicate with software engineers including reviewing software documentation and providing feedback to client staff
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Support business development efforts by identifying opportunities within existing accounts and identifying new opportunities, as well as participating in proposal development and review.
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Actively participate in mentoring and coaching activities for junior level team members, sharing expertise in project execution, scientific writing, and regulatory knowledge.
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Engage in thought leadership efforts to increase visibility as a subject matter expert in key areas of practice.
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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:
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Ph.D. in a related scientific discipline from an accredited institution strongly preferred, with at least 5-8 years of relevant industry, consulting, and/or FDA experience.
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Alternatively, a Master's degree in a related discipline with at least ten years of relevant experience.
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Deep understanding of submission requirements for software and cybersecurity
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Detailed knowledge of the types of information and the level of detail needed in all the software documentation, including cybersecurity and any details related to machine learning algorithms.
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Prior consulting experience and/or direct FDA or other regulatory interaction strongly preferred.
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Proven ability to lead scientific projects and manage client engagements independently.
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Demonstrated success in business development and sales growth, primarily through existing client relationships.
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Strong technical writing, analytical, and research skills.
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Knowledge of regulatory pathways and strategy development, including familiarity with alternative approaches to regulatory challenges.
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Effective interpersonal communication and mentoring skills.
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Ability to manage competing priorities in a dynamic, deadline-driven environment.
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Ability to create effective PowerPoint presentations and leverage current software and tools.
Key Performance Indicators:
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Contribution to team revenue and overall business development
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Achievement of individual billable and sales targets
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Quality and timeliness of client deliverables
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Strengths of client relationships and client satisfaction
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Mentorship and development of junior and mid-level staff
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Contributions to thought leadership and professional visibility
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Demonstrated teamwork and leadership capabilities
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 accommodations may be made to enable individuals with disabilities to perform the essential functions.
