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 Consulting Operations team as a Consultant, Project Associate (Regulatory Affairs) today!

In this role, you will leverage your Regulatory expertise to provide support to Halloran clients, and serve as a key internal partner to project leads.

Characteristic Duties:

• Assist with FDA and other Health Authority requests and regulatory filings such as progress and safety reports
• Help to coordinate the submission process for clinical and commercial submissions
• Manage FDA and other Health Authority correspondence and support interactions with Health Authorities as needed
• Support project development, including developing landmarks and desired outcomes, communication plans, resource and budget objectives and ensuring understanding of all partners; ensure progress of these goals
• Regularly collaborate with client and Halloran leaders to report on project progress and advise on solutions, assisting in developing agendas and taking minutes
• Communicate and develop solutions to address any risks or issues for project impact and long-term success of client and Halloran
• Support project lead in educating existing and potential clients on Halloran services and opportunities for partnerships, assisting with developing support strategy
• Assist in the authoring of proposals and statements of work
• Participate in internal activities such as publishing articles and other examples of thought leadership, serving as a subject matter representative on process optimization efforts
• Continue to build subject-matter expertise by attending conferences, workshops, and other relevant learning opportunities, speaking as a face of Halloran if opportunities arise
• Mentor internal Halloran team members (up, down, and across the organization) to ensure success of company and client goals
• Other duties and responsibilities as assigned

Qualifications:

Required:

• Bachelor’s Degree and a minimum of four years of related experience in a Life Science setting focusing on Drug, Medical Device, Biologic or other therapeutic development
• Familiarity with current regulatory guidance, good quality practices (GxPs), legislation, and industry trends
• Ability to work creatively and analytically to balance multiple priorities, tasks, and sophisticated issues using logical and efficient processes
• Understanding of selection methods, techniques and evaluation criteria to tackle sophisticated issues

Preferred:

• Advanced Education and/or Certifications
• Prior Consulting experience
• Experience with scientific, medical, or technical writing

Compensation:

The targeted gross compensation range for this position is between $65,000.00 and $95,000.00 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.

Notice:

We are committed to equal employment opportunities for all applicants and employees. We do not discriminate against employees or applicants for employment based on any protected class including, but not limited to, race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age, veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.

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.