Study Director Job at RQM+
RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
The Study Director is responsible for organizing and leading projects for regulatory clients. The position includes fielding customer inquiries for regulatory testing services in conjunction with the project manager to ensure customer satisfaction. It is the responsibility of the study director to lead a team of chemists in the implementation of regulatory protocols to obtain accurate results.
Responsibilities
- Overall responsibility for the conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results
- Manages regulatory timelines and budgets
- Performs functions in accordance with GLPs and other applicable regulations
- Consults with Sponsor, project manager and others during protocol development to optimize protocol design to appropriately address study objectives
- Responds to inquiries from clients and other relevant parties regarding scientific aspects of studies. Actively participates in client discussions regarding studies
- Monitors, tracks, and communicates study milestones throughout departments
- Ensures that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded, and verified
- Ensures that unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and that corrective action is taken and documented
- Manages and mentors a team of chemists in terms of lab responsibilities, analytical strategies, industry regulations and labs' philosophies and culture
- Any other duties assigned by the supervisor
- This position will not have supervisory responsibilities
Requirements
- Master of Science or PhD in Chemistry or equivalent education/experience
- Must be GLP/GMP Trained
- Demonstrates expertise in a variety of the field’s concepts, practices, and procedures
- Relies on extensive experience and judgment to plan and accomplish goals. May provide consultation on complex projects and is considered to be the top-level contributor/specialist
- Provides direction to all chemists and senior chemists working on each project to ensure project deadlines are met
- A wide degree of creativity and latitude is expected
- Strong Personal Integrity
- Committed to Serving the Customer
- Mastered running the instruments within a single division.
- Able to advise chemists as to the most likely cause of failure for instruments in their division
- Ability to read, analyze, understand, discuss and interpret complex scientific and regulatory documents. Ability to effectively communicate scientific conclusions
- Ability to utilize and interpret appropriate mathematical and statistical methods for analysis of scientific study data
- Mastered writing data from all divisions and able to direct the writing of large complex reports.
- Excellent verbal and written communication skills
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds
Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!
We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
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