Thermo Fisher Scientific

Compensation

Full Description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Location/Division Specific Information This position is part of the Regulatory and Clinical Affairs organization which ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements (domestically and internationally) and is submitted to the FDA in a complete, accurate, and timely manner for approvals in support of the business units. Discover Impactful Work: Your work will impact the quality of the FDA submissions and help secure the necessary approvals for our products to be marketed and reach the patients who will ultimately benefit from these companion diagnostics. A Day in the Life: The primary role of this position is targeted toward Clinical Studies planning, core team support, and CRO Management. In this role, the primary responsibilities include: Participate as a clinical study representative for project core teams. Participate in lab assessment visits and lab selection process. Work closely with the core team and regulatory representative during the studies' planning, coordination, and management phases. Document clinical studies plans/ reports for inclusion into the Design History File (DHF) project. Interact as the primary clinical studies representative to Pharmaceutical partners concerning IVD study requirements. Facilitate internal and external clinical studies preparation and planning meetings. Interact as the primary interface between the company and CRO to ensure that CRO activities and timelines are in coordination with regulatory and project requirements. Real time elevation of Clinical studies issues to Project and Regulatory Management. Mentor/ train junior-level personnel. Keys to Success: Education and Experience A B.Sc. degree in biology, chemistry, bio-engineering, or related science is required. Solid understanding of Good Clinical Practices is required. 4+ years working in the In Vitro Diagnostic or Medical Device Industry; companion Diagnostic experience is a plus. 4+ years of demonstrated experience managing in-house and/or external clinical studies preferred. Certification as a Clinical Research Professional (CCRP) is a plus; If certification is not in place, class work/course work in Good Clinical Practices is strongly preferred. Experience working with multi-functional project teams is required. Digital literacy, including spreadsheet, database and word processing applications required. Knowledge, Skills, Abilities Ability to work on projects where the project and its team members may be located at other sites. Should be at ease with direct communication with internal project team members, external CROs and Pharmaceutical partners. Willing to travel away from home on an occasional basis. High energy level; positive attitude; works well under stress; assertive and effective communicator. Benefits: We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation and Benefits The salary range estimated for this position based in California is $112,500.00–$130,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.