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Regulatory Project Coordinator (HYBRID ROLE)

Somerville, New Jersey, United States

 

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Regulatory Project Coordinator (HYBRID) on a permanent basis at Somerville, NJ.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

 

Responsibilities

•    Assist in the planning and tracking of long-term regulatory projects and submission timelines.
•    Regularly communicate with clients to understand their needs and proactively address them.
•    Coordinate cross-functional team meetings and facilitate communication to ensure project milestones are met.
•    Maintain accurate project documentation including project plans, timelines, and status reports.
•    Drive regulatory updates and assist in assessing their impact on ongoing projects.
•    Contribute to the development and improvement of regulatory project management processes and tools.
•    Track project deliverables and resource utilization using appropriate tracking tools to provide direction and support to the project team.
•    Identify and escalate issues and potential issues in a timely manner to ensure efficient resolution
•    Provide independent advice on the management of projects based on lessons learned and gained experience.
•    Contribute to the preparation of RFI/RFPs/defense bid and act as a guide to the sales and business development team.

Skills

•    Bachelor’s degree in Life Sciences, Regulatory Affairs, Project Management, or a related field. Combination of training in Life Science and Business preferred. 2+ years of experience in regulatory affairs, project coordination, or a related role.
•    Technical system skills including tools specific for project management activities (MS Office, Power BI, etc.)
•    Strong organizational and time management skills.
•    Excellent written and verbal communication skills.
•    Ability to present complex information to various levels and adjust your message appropriately.
•    Ability to work collaboratively in a team environment and manage multiple priorities.
•    Ability to present confidence in front of clients and present ideas
•    Proficiency with Microsoft Office (Word, Excel, PowerPoint); experience with project management tools is a plus (e.g., MS Project, Smartsheet, Trello, or similar).

 

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.


#LI-PR1 #Hybrid

 

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