Consultant in Warrington, Pennsylvania

Consultant, Life Sciences

Why choose Just in Time GCP as the next step in your career

Because we help organizations achieve operational excellence! Our team of professionals assist biotech and pharma companies develop and streamline compliant processes, proactively prepare for regulatory inspections, implement and optimize eClinical technologies, and provide an efficient and effective resourcing strategy for Sponsor oversight and TMF management. We take great pride in knowing that our GCP compliance support plays a role in helping clients achieve their goal of getting critical therapies to market and changing patients’ lives.

We are a fast-growing industry leader in the TMF (Trial Master File) Services, Inspection Readiness and Clinical Compliance (GCP) Consulting space. In fact, we have been recognized by INC500 for the past 3 years, as well as one of JP Morgan’s 50 Fast Growing Woman Owned/Led Businesses for the previous 2 years and most recently an INC500 Best Workplace. Our Founder & CEO was recently named EY Entrepreneur of The Year® 2022 Greater Philadelphia Award winner.

Are you looking to join an organization where you can make an immediate impact and champion the value of inspection readiness and GCP Compliance? Then you are ‘Just in Time’ to be a part of our amazing growth!

What you will do — Highlights of Responsibilities include:

• Participate in projects related to GCP compliance, implementation of optimized Trial Master File oversight frameworks, Sponsor oversight gap assessment, process redesign & optimization, and inspection readiness
• Using your knowledge of clinical operations, participate gap assessments in both GCP compliance and operational efficiency to establish organizational current state
• Leverage your knowledge of the drug development process and regulatory inspection trends/findings to help organizations develop the people, processes, and technology that drives GCP compliance and regulatory inspection preparation
• Leverage your understanding of applicable regulations and risk management to support organizations in right sizing and prioritizing their remediation of gap findings
• Develop training as required by project scope of work
• Participate in process mapping activities with clients to develop processes that are in alignment with client needs and remain compliant with GCP requirements
• Participating in internal process improvement efforts

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To succeed in this position, the ideal candidate would have:

• Undergraduate degree and minimum of 7 years’ experience in life sciences consulting or clinical operations, or equivalent combination of education and experience; graduate degree preferred or equivalent combination of education and experience
• Experience with global (domestic and international) regulatory and ethics requirements, and industry best practices
• Experience supporting risk-based Clinical Quality Assurance activities (e.g., risk assessment, GCP auditing, CAPA authoring/remediation)
• Experience with the drug development process and clinical trial conduct
• Experience supporting regulatory agency inspections
• Experience drafting procedures/QMS documents (e.g., Manuals, Policies, SOPs) and tools/guidelines/QRCs
• Experience preparing presentations and/or visualizations that effectively tell a story, particularly as applied to client deliverables and project management

The benefits of being part of the Just in Time GCP team

• This position is a virtual position.
• Competitive compensation package that recognizes your expertise and contributions.
• Enjoy flexibility in your schedule, promoting work-life balance. This includes Paid Time Off, paid holidays, winter break, and “half day Fridays” during the summer.
• A comprehensive range of healthcare options for you and your loved ones, including medical, dental, and vision plans (premium cost is shared between you and us), long with life insurance and short-term income replacement plans.
• Investment in your future financial well-being with a 401(k) savings plan including a company match.
• Collaboration with a vibrant, enthusiastic team of individuals who are passionate about what they do and who they work with.

Just in Time GCP provides equal employment opportunities to all employees and qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other characteristic protected by law.

To apply, send an email to [email protected] including your resume and answers to the questions below:

1. How many years of Clinical Research experience do you have?
2. Different types of health authority inspections you have supported (i.e. FDA, MHRA, EMA, PMDA, etc)
3. Which eTMF systems you are familiar with?
4. Do you currently possess the legal right to work in the United States without requiring visa sponsorship now or in the future?
5. In which state are you located?