Regulatory Project Management Specialist

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Regulatory Project Management Specialist at a prestigious Fortune 500® company working in Foster City. 

 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position (Brooke.Schoen@kellyservices.com) however your resume must be received via the “Submit Resume” button included within.

 

Job Title: Regulatory Project Management Specialist

 

Pay: $60

 

Duties:

The Regulatory Documentation and Submissions (RDS) department works as a global team to drive and innovate document and submission strategy, as well as training and education excellence. The department is made up of four individual departments including Quality, Medical Writing, Disclosure and Transparency, and Regulatory Operations. The Quality department provides various services including, but not limited to: process improvement support, quality reviews (data/content verification and consistency, style application, editing), audit readiness support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications. 

Specific Responsibilities: 
• Expands development and support of the software/platform (KaiNexus) utilized to manage small to mid-level departmental improvement initiatives. 
• Performs independently as executing Project Manager for improvement initiatives. 

Essential Duties and Job Functions : 
• Works with project lead and stakeholders to ensure project framework, objectives, and milestones are aligned with business objectives. 
• Schedules and runs project team meetings, creates meeting minutes, develops next steps/action items, and updates and captures all project artifacts in KaiNexus. 
• Works to obtain stakeholder alignment and feedback ensuring productive meetings and initiatives remain on track and within target 
• Monitors the progress of all initiatives within KaiNexus to ensure timelines are met and project remains within scope. 
• Generates progress reports of all ongoing and planned initiatives utilizing tools in KaiNexus. 
• Proposes and implements plans to resolve complex issues and executes corrective actions. 
• Drives continued team progress on multiple projects during and between meetings through meeting follow-ups, conversations, and emails. 
• Develops features within KaiNexus to ensure platform meets the needs of RDS tracking and reporting 
• Assists in the development of training tools for RDS users. 

Knowledge, Experience and Skills : 
• Fluency in project management platforms/software 
• Familiarity with highly regulated industry environments or drug development 
• Excellent program and project management, consensus-building, and leadership skills 
• Exceptional verbal and written communication skills and interpersonal skills. 
• Ability to collaborate across the organizational hierarchy and cross-functionally 
• Experience managing teams in a business operations or technical processes environment 
• Has developed organizational skills; is detail oriented; and able to work in a fast paced, deadline-driven environment. 
• Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate 
• Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations. 
• Is capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and SharePoint 

Typically requires: 
• A BS degree 
• 5+ years of relevant experience with a Bachelor’s Degree 
• 2+ years of experience in the biotechnology or pharmaceuticals industry 
• Familiarity with KaiNexus or similar platform 
• Experience with Six Sigma or other process improvement methodologies 
• Experience managing and collaborating with virtual or remote teams 
• Experience with SharePoint administrator activities

 

 

We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com.

Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

 

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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