Project Manager, Regulatory Affairs & Scientific Writing Position Available In Morris, New Jersey

Project Manager, Regulatory Affairs & Scientific Writing Aleon Pharma International, Inc. – 3.5 Parsippany-Troy Hills, NJ Job Details Full-time $70,000 – $80,000 a year 11 hours ago Benefits Profit sharing Paid parental leave Health insurance Dental insurance 401(k) Paid time off Parental leave Vision insurance 401(k) matching Professional development assistance Opportunities for advancement Life insurance Retirement plan Qualifications Management 11+ years No experience needed Mid-level Scientific writing Regulatory affairs Project management software Project management experience Leadership Communication skills FDA regulations Time management Full Job Description Project Manager, Regulatory Affairs & Scientific Writing Aleon Pharma International, Inc. (Aleon), headquartered in Parsippany, New Jersey, is a consulting firm dedicated to providing global regulatory affairs, clinical development, pharmacovigilance, and quality and compliance services. For more than 15 years, our experienced team has worked closely with innovative sponsor companies and offered solutions tailored to each client’s individual requirements. As a result, our clients expedite their product development and reach patients sooner to ultimately save more lives.

• Best Workplaces Honoree – National top 3% for employee engagement
• Best Workplaces – National top 5% for employee engagement
• Outstanding Employer Award by

New Jersey Business & Industry Association Job Type:

Full-Time Job Location:

Parsippany, NJ (Hybrid WFH)

Job Responsibilities:

Lead regulatory affairs projects, including formal meetings with the FDA, Investigational New Drug (IND) applications, NDAs/BLAs (New Drug Applications / Biologics License Applications), Orphan Drug Designation (ODD) applications, expedited program applications, and more from project initiation to project completion. Serve as the primary liaison between the FDA and Sponsors to ensure regulatory understanding and compliance Stay up to date on current FDA/EMA guidance and regulations in an evolving regulatory landscape Analyze and summarize scientific and clinical data for the preparation and review of regulatory documents prepare/review regulatory documents for submissions to FDA/EMA. Manage projects through effective communication with Aleon’s clients and internal department heads and team members to successfully achieve project milestones. Ensure that projects are completed within the timeline, scope, and budget. Plan, coordinate, and monitor all project changes. Maintain professional relationships with Aleon’s clients and strategic partners. Utilize Aleon’s Asana project management software for streamlining project activities and accurately recording hours data. Review resource availability and allocation and identify areas for improving efficiency. Set project priorities by communicating with senior management.

Qualifications:

Advanced degree in pharmaceutical or scientific background required.

Skills and Requirements:

Excellent leadership, organizational, time management, and communication skills. Strong desire to learn Ability to balance multiple projects and adapt to changes in timelines and client priorities. Creative and open-minded. Proactive and ambitious. Ability to set priorities by working with senior management. Proficiency in assessing and communicating scientific data for regulatory document preparation What We Offer to

You:

Aleon offers competitive compensation with many benefits, including paid time off, performance-based bonus, 401(k), profit sharing program, health, dental, vision, and life insurance, and much more. Aleon has a dynamic and flexible working environment where professionals dedicated to learning can truly thrive. Limitless learning possibilities, and fantastic career advancement opportunities. Friendly and positive work environment. Dynamic company culture where employees are engaged and motivated. We are confident that you will find that Aleon is a very rewarding and exciting place to work. If you feel that you are a good fit for this position, email your resume with confidence to Equal opportunity employer. Candidate must be authorized to work in the US.

Job Type:

Full-time Pay:

$70,000.00 – $80,000.00 per year

Benefits:

401(k) matching Life insurance Paid parental leave Parental leave Professional development assistance Retirement plan

Schedule:

8 hour shift Day shift No weekends

Work Location:

Hybrid remote in Parsippany-Troy Hills, NJ 07054