Medical Scientific Affairs Project Operations Manager ASP
Medical Scientific Affairs Project Operations Manager ASP
Posted on :
26-04-2025
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1 Vacancy
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Job Description
Description
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 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 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 prepost mtgs route through multistep 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 startup maintenance tracking closeout: For all approved grants across products work with investigators to ensure startup 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 Bachelors Degree in Life Sciences Healthcare Administration or related fields such as Nursing Pharmacy.
- Years of Related Experience: Minimum of 510 years relevant project management experience preferably in the medical device or pharmaceutical industry within Medical Affairs.
#LIRB
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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