When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are looking to fill a Scientist III or Principal Scientist I position working as a full-time employee of Parexel FSP on long-term assignment remotely for one our clients located in Rahway, NJ. Must be willing to work East Coast hours. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship.
Responsibilities
- Manages shipments of raw materials, active ingredient, analytical samples, and drug product in support of development programs
- Completes shipping documentation
- Establishes and maintains a tracking system for all inbound and outbound shipments
- Learns processes for domestic and international shipments, which can either be inbound or outbound from the facility
- Collaborates with project team leads to develop demand schedule for shipments
- Extracts internal release documentation from internal repositories and provides same to project teams and external partners as needed
- Clearly communicates requirements and expectations for timelines and deliverables to both internal and external stakeholders
- Coordinates shipping documentation with external partners in accordance with internal processes and contractual terms
- Monitors delivery of shipments; works closely with logistics personnel to troubleshoot delays; keeps teams informed of expected dates of delivery
- Supports reconciliation of import-for-export entries
- Supports shipping related deviations, initiation through event closure; works closely with internal partners, including Quality, to support event closure
- Must be able to work core hours appropriate to the Eastern Time Zone
Qualifications
- Scientist III - Bachelor’s degree in a relevant discipline with 3-5 years of experience; or a Master’s degree in a relevant discipline with 1-2 years of experience
- Principal Scientist I – Bachelor’s degree with 7+ years of relevant experience or Master’s degree with 3+ years of relevant experience
Required Skills and Experience
- Strong Systems, Applications, and Products in Data Processing (SAP) experience is a MUST
- Strong Supply Chain Manager/Logistics background
- Solid knowledge of global GDP/GMP, Distribution & Logistics area, regulatory requirements, and good documentation practices
- Comfortable with the deployment of a new process and able to come with initiatives to handle the "Unknown"
- Excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in evolving environments; must be able to apply sound risk management
- Microsoft Office (proficient Excel, Access, and PowerPoint user)
- Strong communication skills, both written and verbal; effective interpersonal skills
- Effective influencing skills based on strong business understanding and analysis
- Able to manage multiple priorities
- Able to function well in a dynamic, cross-cultural, and changing corporate environment
Desired Skills and Experience
- Experience in Quality Systems (i.e., Deviation Management), Quality Assurance and Quality Control is a plus
About Parexel FSP
The CMC Operations group is part of Parexel FSP. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.
Come join us!
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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