Precision Medicine Group, LLC is the top tier global provider of precision medicine research services and creative commercialization solutions for life sciences companies. After completing the largest private investment raise of a life sciences services company in 2012, we have rapidly grown through a series of acquisitions and 20%+ annual organic growth to more than 1,900 people in over 34 offices across the U.S., Canada and Europe. We are unusually positioned for continued growth as we expand the company’s global footprint and develop leadership in the most creative areas of life sciences as we help our clients develop and deliver lifesaving medical treatments to patients across the world.
The Precision for Medicine team develops assays and runs global logistics for Clinical Trials by using biomarkers to stratify patients, incomparably improving R&D efficiency and success for our clients. We lead every aspect of clinical trials from sites to biomarkers to diagnostics, dramatically accelerate our clients pathway from proof of concept to drug approval.
We encourage high-energy, dedicated team members who enjoy a challenge, thrive in the details and flourish in dynamic environments to invest in learning more about us. If you are no stranger to taking charge and collaborating to deliver excellent work, we have an opportunity for you!
About you:
You have quick troubleshooting and oversight abilities; knowing what to note and what to ignore
These terms describe you; intuitive, independent, inventive,transparent, reliable, responsible, punctual, organized and efficient
You have excellent people skills and can form a cohesive team where members help and support each other
You are ambitious, committed to life-long learning, can balance conflicting priorities while making it look easy and take great pride in your work product
How you will make a difference:
You will perform project management activities related to in vitro diagnostic (IVD) companion diagnostic product development programs at Precision’s ISO13485:2016, CAP/CLIA certified facility
You will lead the laboratory design control process for the development of companion diagnostics (CDx), spanning feasibility, development, design verification, and design validation through to regulatory clearance or approval
You will author or review design control documentation such as design requirements, product requirements, manufacturing assessments, design and development plans, FMEAs, risk management plans, raw material documents, and part number documents
You will build and lead multiple project timelines, budgets and revenue goals, resource plans, understanding critical path and establishing solid forecasting metrics and scheduling practices – fully exploring new ideas that optimize quality and efficiency.
You will be the “face of the business” as a communication liaison among internal and external team members, striving to exceed customer expectations.
You will collaborate with department peers when communicating, coordinating and prioritizing applicable repository and laboratory activities.
Provide support for activities related to CDx post-market requirements and commercial sample testing
Qualifications:Minimum Required:
Bachelor’s Degree in Biology or related field
3 years’ experience developing products under design control
3 years’ experience in Project Management in a scientific or technical discipline managing large, complex projects
Other Required:
Strong communication, interpersonal, organizational and multi-tasking skills
Strong understanding of QSR and ISO regulatory requirements
Strong understanding and experience with Design Control requirements
Excellent use of judgment and discretion required
Proficiency in MS Office (Word, Excel, PowerPoint)
Highly organized and detail-oriented
Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities
Ability to read, write, speak fluently and comprehend the English language
Preferred:
Minimum of 5 years’ experience developing products under design control
Minimum of 5 years’ experience in Project Management in a scientific or technical discipline managing/leading large/complex projects
Experience in developing in vitro diagnostic products under design control
Experience in writing technical grant or contract proposal responses
Experience with project management software such as MS Project
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
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