The Medical & Scientific Affairs Project & Operations Manager will work under the supervision of the Chief Medical & Scientific Officer (CMO). This role involves providing project coordination expertise to support Medical & Scientific Affairs functions, promoting standard work development, and ensuring MSA projects meet schedules. The manager will interact with personnel across the organization, including Quality, Risk Management, R&D, and Regulatory, as well as customers when needed. In addition, he/she will interact with customers as needed.
Under limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
The Medical & Scientific Affairs (MA) Project & Operations manager is responsible for supporting efficient operations, vendor oversight, training, budgeting, reporting and project support for the Medical Affairs department, in accordance with compliance guidelines
Maintaining project flow and task deadline delivery for MSA projects.
Assist in the planning, execution, and monitoring of medical affairs projects. Track project timelines, deliverables, and budgets to ensure successful completion.
Develop and maintain daily management workstreams and dashboards.
Support driving workshops, meetings and tracking the department deadlines.
Identify opportunities for process improvements and implement best practices to enhance operational efficiency.
Organize and coordinate medical affairs events, such as advisory board meetings, conferences, and training sessions.
Coordination of Medical Affairs attendees at scientific congresses
The role will participate in the execution of Medical & Scientific Affairs strategies and goals commensurate with Fortive objectives.
Assist in the development and implementation of medical information systems and databases.
Maintain and help develop scientific reference library/database.
Investigator Initiated Study (IIS) Program:
Manage IIS Review Committee Meeting activities: Track and review all new proposals/protocols received, conduct committee meetings, collaborate with Medical Director pre-post mtgs, route through multi-step review process including but not limited to detailed meeting minutes, requests for additional info, post meeting approvals, development and coordination of communications with internal and external stake holders/Investigators in compliant manner
IIS Contracting and Fair Market Value (FMV) Process: Work with legal to ensure contracts reflect project accordingly
Review budget, perform compliance checks (OIG, FDA Debarment List, etc.), document/archive, ensure consistency and accuracy in FMV
Study start-up, maintenance, tracking, close-out: For all approved grants across products, work with investigators to ensure start-up documents received, reviewed and accurate prior to providing study drug or payments
Track milestones & process payments, provide arcuate accruals to Leadership
Oversee Software and AI tool portfolio for MSA.
Support Medical & Scientific Affairs in the generation of accurate and reliable medical information to ASP functions and prioritizing medical information requests (MIR).
Assist in the drafting of responses to MIR, including FAQs, standard response letters, etc.
Collaborate with various departments, including regulatory affairs, QA and product SMEs to ensure accuracy and consistency in medical information.
Ensure the confidentiality and security of sensitive medical information.
Maintain accurate records and databases related to medical affairs activities, including clinical studies, publications, and regulatory submissions.
Conduct literature searches and review scientific publications to support Medical and Scientific Affairs functions. This can include medical writing.
Willing to travel up to 10% USA
QUALIFICATIONS
Education: Minimum of a Bachelor's Degree in Life Sciences, Healthcare Administration, or related fields such as Nursing, Pharmacy.
Years of Related Experience: Minimum of 5-10 years relevant project management experience, preferably in the medical device or pharmaceutical industry within Medical Affairs.
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.
Pay Range
The salary range for this position (in local currency) is 120,500.00 - 223,900.00
The salary range for this position (in local currency) is 120,500.00 - 223,900.00
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.
