Job Description:
We are seeking a highly skilled and experienced Project Manager with a background in Acute Pain Medical Affairs to join our dynamic team. The ideal candidate will manage multiple medical affairs projects, including clinical research, medical education, regulatory submissions, and product launches related to acute pain treatments. This role requires a strong understanding of the healthcare industry, pain management, and medical affairs functions, along with excellent project management skills.
Key Responsibilities:
- Project Planning & Execution: Develop detailed project plans for medical affairs initiatives, including timelines, resource allocation, and deliverables related to acute pain management programs.
- Cross-functional Collaboration: Collaborate closely with internal teams (Medical Affairs, Regulatory, R&D, Commercial, etc.) and external stakeholders (KOLs, healthcare providers, regulatory bodies) to ensure project goals are met.
- Clinical Research Support: Oversee the planning and execution of clinical trials, post-marketing studies, and real-world evidence (RWE) projects in acute pain management.
- Medical Communications & Education: Lead the development and dissemination of scientific and medical information through publications, presentations, and educational programs targeted at healthcare professionals.
- Compliance & Regulatory Management: Ensure all activities comply with relevant regulations, including FDA, EMA, and other local guidelines, and facilitate timely submissions of regulatory documents.
- Budget Management: Monitor project budgets, including forecasting and reporting on costs associated with medical affairs projects.
- Risk Management: Identify and mitigate risks to project timelines and objectives, ensuring proactive communication of potential issues to stakeholders.
- Performance Tracking: Track key project metrics and prepare reports to communicate progress, outcomes, and learnings to senior management and relevant stakeholders.
Qualifications:
- Education: Bachelor's degree in life sciences, healthcare, or related field required. Advanced degree (e.g., PharmD, PhD, MD, or MBA) preferred.
- Experience:
- 5+ years of experience in project management within Medical Affairs or a related field.
- Proven experience managing projects in acute pain, pain management, or a relevant therapeutic area.
- Experience in clinical trial operations, medical education, and regulatory submissions.
- Project Management Skills:
- Proficient in project management methodologies and tools (e.g., PMP certification or equivalent preferred).
- Strong ability to manage multiple projects with competing deadlines.
- Industry Knowledge:
- In-depth understanding of acute pain management and associated therapeutic areas.
- Familiarity with regulatory guidelines (FDA, EMA) and Good Clinical Practice (GCP) standards.
