Lead Consultant, Organizational and Quality Solutions – R&D Technology
Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran’s Organizational and Quality Solutions team as a Lead Consultant today!
In this role, you will partner with a variety of companies across the pharmaceutical, biotechnology, and medical device space to provide research and development (R&D) technology support and leadership. You will use your understanding of the technology solutions used in supporting clinical research, process and performance metrics, compliance and change management and exceptional communication and critical thinking skills to transform these organizations and how they use their technology platforms.
- Assess client processes for gaps, inefficiencies, and redundancies; design effective solutions to address streamlining operational processes, and improving efficiency and compliance with a particular focus on technology-focused projects, such as:
- Partner with companies to determine technology current and future needs supporting clinical development across clinical operations, data management, quality, regulatory and clinical safety
- Assess client computer systems and infrastructure for compliance gaps and/or process inefficiencies; develop and implement remediation plans
- Work closely with software vendors on client’s behalf to determine system design and configurations needed to implement business requirements
- Partner with client organization to define business and system requirements
- Advise clients on compliance strategies for technology projects
- Manage and execute implementation of software for clients including activities such as system selection, vendor auditing, business requirement mapping, validation planning/oversight, system documentation, software testing, data migration, change control, and training
- Develop and implement policies and procedures defining compliant Software Development Lifecycle (SDLC) best practices for life science organizations that develop or use GxP regulated software
- Partner with organizations to measure and validate the effectiveness of continuous improvement and change initiatives (e.g., piloting, training, hypercare).
- Organize, participate in and/or lead meetings to effectively facilitate decisions according to good meeting management practices.
- Support planning and conduct of workshops (e.g., process mapping) or other brainstorming sessions.
- Establish project scope, expectations, plan, and details that ensure high quality, timely deliverables within budget.
- Supervise, analyze, and report project status, utilizing appropriate communication methods to update and solicit approval from internal team and client partners.
- Identify, mitigate and analyze the impact of any project risks, supporting timely resolution and client-facing response.
- Educate existing and potential clients on Halloran services and identify future opportunities. May author proposals and statements of work.
- Participate in internal activities such as developing new product offerings and consulting services, internal process optimization activities and speaking publicly at conferences and workshops.
- Coach and mentor Halloran team members to achieve company and client goals, in direct management, project-based, or matrixed relationships.
- Other duties and responsibilities as assigned
- Bachelor’s Degree and a minimum of ten years of experience in in a core product development function (e.g., Clinical Operations, Clinical Affairs, Regulatory, Quality, Medical, Safety, etc.) in a life science (biotechnology, pharmaceutical, device) setting with proven expertise in two or more of the following areas: technology assessments, validation, implementation, clinical development technologies, decentralized trials, data integrity and related regulations, and/or systems auditing
- Demonstrated history of participation in and/or leading R & D technology selection, implementation and management
- Demonstrated technical understanding of adjacent functional areas
- Familiarity with current regulatory guidance, GxP guidelines, legislation, and industry trends
- Ability to work creatively and analytically to balance multiple priorities, tasks, and sophisticated issues using logical and efficient processes.
- Exercise good judgment in selection methods, techniques and evaluation criteria for sophisticated, complex issues that may require in-depth evaluation of variable factors.
- Advanced Education and/or Certifications (Audit, Lean Six Sigma, Lean Business Process, PMP, Change Management)
- Prior Consulting experience, either externally, or in an internal consulting role (e.g. R&D Technology Business Partner)
- Curiosity and awareness of evolving competitive, regulatory, and best practice environment for life science companies
The targeted gross compensation range for this position is between $120,000.00 and $175,000.00 annually. Please note: this compensation range is Halloran’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, Halloran may ultimately pay more or less than the posted range.
Halloran Benefits and Perks:
The benefits of being a Halloran employee go beyond the unparalleled opportunities of your day to day work! We offer an annual, discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, and a 401(k) Plan for all full-time employees. We offer reimbursements for Health & Wellness Programs and Memberships, opportunities for continued learning through conference and continuing education programs. We also offer a Self-Managed PTO Policy, Commuter FSA Benefits, and many other benefits.
Halloran Consulting Group, Inc. COVID-19 Considerations:
Successful applicants for employment must provide proof of full COVID-19 vaccination as a condition of entering Halloran’s offices, attending Halloran sponsored events (at Halloran offices or otherwise), and traveling to client sites, subject to requests for accommodation. Individuals will be considered fully vaccinated two weeks after a second shot of a two-shot vaccine regimen (i.e., Pfizer or Moderna) or two weeks after a single shot of the Johnson & Johnson vaccine.
Halloran does not sponsor visas for employees.
All remote employees are expected to have a consistent home internet connection with speeds of at least 25Mbps while working remotely.
Halloran Consulting Group, Inc. is an equal opportunity employer committed to diversity, equity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local nondiscrimination laws).
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by an authorized representative of Halloran.