The Medical & Scientific Affairs Clinical Liaison (CL) involves providing scientific support for the conduct of and publication of scientific studies. The CL will interact with personnel across the organization including R&D, and Regulatory, Marketing as well as customers when needed. The CL provide on site monitoring of studies as well as assist in the development of writing protocols and maintaining scientific references for publications and white paper development. 

Under limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

Maintain and help develop scientific reference library/database including using AI scientific tools. Support R&D and Investigator Initiated Study (IIS) Programs as site monitor and participate in protocol execution and scientific studies. Manage IIS Review Committee Meeting activities: Track and review all new proposals/protocols received, conduct committee meetings, collaborate with Medical Team pre-post mtgs. Work on site in Irvine with R&D on Pilot Studies in readiness for External Studies Coordination of Medical Affairs attendees at scientific congresses Track study milestones & process payments with Medical Affairs Leadership Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. Follow and Maintain Scientific Reference Database for Publications and Medical Affairs Support Conduct literature searches and review scientific publications to support Medical and Scientific Affairs functions. This can include medical writing.

Qualifications:

Minimum of a Bachelor's Degree in Life Sciences, Healthcare Administration, or related fields such as Nursing, Pharmacy. Master’s a plus.  Minimum of 5 years site monitoring and or Clinical Research Organization and/ or Medical Affairs Study Experience Proven technical and scientific writing skills Travel up to 25%  This hybrid role is expected to work on site (Irvine) 2-3 days as needed to do studies at the R&D laboratory Highest level of integrity and ethical decision making Innate desire to focus on patient safety outcomes Exceptional interpersonal skills and willingness to work in a team environment Strong organization skills with the ability to prioritize task and meet deadlines Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) Proficiency with Project Management/Dashboard Platform Software Familiarity with project management tools and software Ability to coordinate and lead multiple projects simultaneously Ability to understand and assess complex clinical matters Collaborative work style (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

Nice-to-have:

Experience in medical devices, pharmaceuticals or diagnostics Knowledgeable of U.S. Food and Drug Law and regulatory, drug safety and/or device vigilance and/or regulatory/clinical research requirements in major geographies.

#LI-RB

 

Fortive Corporation Overview

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 17,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

About Advanced Sterilization Products

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.

Bonus or Equity
This position is also eligible for bonus as part of the total compensation package.

Pay Range
The salary range for this position (in local currency) is 100,700.00 - 186,900.00