Consultant, Project Associate (Regulatory Affairs)
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 and push beyond the status quo? Join Halloran Consulting Group, Inc. today!
Halloran is looking for a Consultant, Project Associate to join its Consulting Operations practice area. As a Consultant, Project Associate, you will be responsible for establishing project timelines, providing specific subject matter experts support for specific projects, and identify opportunities for project expansion and assist with devising support strategy.
- Assists with the deliverables associated with the project; may be responsible for deliverables independently.
- Executes assigned Regulatory Affairs-focused tasks in scope of work, which may include:
- Start-to-finish project coordination including writing the SOW, driving the timeline and managing the budget
- Assisting with FDA requests and regulatory filings such as progress and safety reports
- Helping to coordinate the submission process for IND, NDA and or IDEs
- Manage FDA documentation and interactions comfortably
- Responsible for various project administrative efforts such as meeting minutes, agendas, etc
- Communicates directly with the client and team/team lead.
- Ensures deliverables meet the time, quality and resource standards.
- May support project lead and SME for customer deliverables.
- Will learn and expand SME knowledge.
- Will act independently on limited scope project deliverables.
- Will support project lead on growing new business with client and identify opportunities to expand the engagement with the client.
- Contributes to deliverables according to the following criteria:
- Focuses equally on results (high-quality deliverables that meet objectives); process (use of logical and efficient processes to achieve results); and relationships (engendering the client’s trust and goodwill among team members)
- Targets personnel for appropriate levels of involvement and decision-making
- Participates in meetings effectively to facilitate decisions, according to good meeting management practices
- Alerts manager and engagement lead to any work conflicts preventing fulfillment of responsibilities, giving enough lead time to address resource issues.
- Manages time effectively, notifying engagement lead and manager of extra capacity when appropriate.
- Identify business development opportunities in existing clients and educates clients on Halloran Services.
- Other duties and responsibilities as assigned
- Bachelor’s Degree and a minimum of four years of related experience
- Experience with document management and publishing systems is required
- Must have extensive experience with Microsoft Word, Adobe Acrobat Professional, Microsoft Excel and Microsoft Project
- Early stage clinical trial experience
- Experience with electronic publishing software
- Comprehensive Medical, Dental, and Vision Insurance
- 401(k) Plan for all Full-Time Employees
- Reimbursements for Health & Wellness Programs and Memberships
- Opportunities for Internal and External Learning through Conference Attendance and Tuition Reimbursement
- Self-Managed PTO Policy
- Commuter FSA Benefits
Our company is committed to equal employment opportunity. We will 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 [over 40], veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.