The Senior Manager for Medical & Scientific Affairs (MSA) will work under the supervision of the Chief Medical Officer (CMO).
Responsibilities include managing external Clinical Advisory, internal Scientific Educational Planning, and Safety Reviews.
Key activities for the MSA include conducting Clinical Safety Reviews with key company functions and coordinating the Global Evidence / Education Strategy and Execution.
If you think you are the right match for the following opportunity, apply after reading the complete description.
The team is currently expanding under the leadership of its new CMO. The Global Medical & Scientific Affairs Function supports ASP's Marketing, Commercial, R&D, Sales, Regulatory, and Educational functions with scientific evidence.
This role involves coordinating and managing the flow of scientific and safety evaluations, both inbound and outbound.
This includes working with Marketing to support claims expansion and evidence support. The role also involves working with several other functions, such as coordinating educational requests with the Sales Team, conducting product assessments with R&D, and working with Regulatory Affairs to complete Regulatory Submissions & Queries.
A proactive mindset in interfacing with other corporate functions and eagerness to grow leadership skills is essential.
Responsibilities include :
- Assessing clinical safety risk documentation.
- Synthesizing Safety Surveillance Plans and Reports.
- Collaborating with teams on Product Quality Safety Surveillance.
- Working with Regulatory, Quality, and R&D functions in assessing complaints.
- Collaborating on Failure Mode Effect Analyses (dFMEA / pFMEA) as a clinical expert.
- Aligning & coordinating activities with both Corporate and Field Marketing Functions on Scientific and Educational Content.
- Managing internal MSA messaging to the entire ASP in coordination with the Communications Director.
- Aligning and coordinating with Field Education on Scientific Content delivery to Internal Teams and Customers.
- Participating in Life Cycle MSA (e.g., assisting with copy review, medical information requests, and Medical Operations).
Years of Related Experience : MSN, MS or PharmD with a minimum of 7-10 years related experience or Doctorate and a minimum of 5 years of related experience.
Knowledge, Skills, Abilities, Certifications / Licenses, and Affiliations :
- Ability to read, assess, and summarize medical and scientific studies.
- Ability to design and write basic scientific summaries and have experience working with teams on scientific studies and study design.
- Excellent written and communication skills.
- Demonstrated experience in basic project management - ability to create work packages and execute timelines for MSA activities.
- Ability to handle confidential information.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
This position is also eligible for bonus as part of the total compensation package.
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.
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