Medical Affairs Associate Manager

2 weeks ago

Foster City, California, United States LeadStack Inc. Full time
Company Overview:
LeadStack Inc. is a distinguished, rapidly expanding staffing services provider recognized as a certified minority-owned business (MBE) specializing in contingent workforce solutions. We are proud to be acknowledged as a Great Place to Work and collaborate with some of the most esteemed Fortune 500 companies globally.

Position:
Associate Manager - Medical Information

Job Duration:
6 months - 1 year

Work Arrangement:
Hybrid model: 3 days onsite and 2 days remote

Compensation:
$55/hr to $60/hr

Key Responsibilities:
1. **Medical Governance Support:**
- Assist the Medical Governance team in overseeing the ecosystem of Medical Affairs activities, including Self-Assessments/CAPAs, Process Documentation, Training, HCP Arrangements Management, Monitoring & Reporting, and Document Management.
- Facilitate self-assessment activities in collaboration with internal partners.
- Aid in managing response management and corrective actions as required.
- Support the resolution of audit findings and the implementation of corrective measures.

2. **Monitoring & Reporting:**
- Contribute to the development of reporting capabilities that reflect Medical Governance operations.
- Identify compliance trends and propose monitoring strategies.
- Assist in routine and ad hoc analysis and reporting.
- Provide support to internal stakeholders regarding monitoring and training challenges.

3. **HCP Arrangements Management:**
- Ensure proper documentation of all Medical Affairs HCP engagements and related activities.
- Coordinate governance submissions and document Committee meeting decisions.
- Manage metric and data reports for the Medical Review Committee and HCP Arrangement Committee.
- Maintain Medical Governance document repositories and information sites.

4. **Cross-Functional Collaboration:**
- Foster strategic partnerships with stakeholders in Medical Affairs, Global Medical Strategy and Operations, Legal, Ethics & Compliance, and R&D Quality.
- Collaborate with various functional groups to enhance Medical Governance as a Quality Business Partner.
- Gather information to escalate critical issues to appropriate levels.

5. **Promoting Compliance Culture:**
- Build trusted relationships with Medical Affairs associates to foster a culture of accountability and compliance.
- Ensure documentation completeness and currency across Medical Affairs activities.
- Advocate for a culture centered on quality, compliance, and patient focus.

Qualifications:
- BA/BS degree.
- Relevant experience in the biopharmaceutical industry is advantageous.
- Understanding of PhRMA code regulations and business requirements.
- Strong organizational and project management skills.
- Demonstrated critical thinking abilities to define and implement compliance standards.
- Effective communication and interpersonal skills for relationship building across organizational levels.

Top Required Skills:
- Strong organizational skills
- Ability to collaborate cross-functionally
- Proficiency in computer applications

Preferred Skills:
- Experience in pharmaceutical organizations
- Data analytics capabilities
- PowerPoint presentation skills

For more information about current opportunities at LeadStack, please visit our website.

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