Requirements: English
Company: Planet Pharma
Region: Brussels , Brussels
Position Overview:
We are seeking a highly skilled and motivated Project Manager to lead the Joint Clinical Assessment (JCA) initiatives within our organization. The successful candidate will be responsible for overseeing the planning, execution, and delivery of clinical assessments in collaboration with cross-functional teams. This role requires a strategic thinker with a strong background in healthcare, project management, and regulatory processes.
Key Responsibilities:
- Project Leadership: Lead and manage JCA projects from initiation through to completion, ensuring alignment with organizational goals and regulatory requirements.
- Cross-Functional Collaboration: Work closely with internal teams, including clinical development, regulatory affairs, market access, and external stakeholders to ensure seamless project execution.
- Regulatory Compliance: Ensure all JCA activities comply with relevant regulations and guidelines, including ICH/GCP standards.
- Stakeholder Management: Develop and maintain strong relationships with key stakeholders, providing regular updates and addressing any concerns promptly.
- Risk Management: Identify potential risks to project timelines and deliverables, implementing mitigation strategies as necessary.
- Budget Oversight: Monitor project budgets, ensuring efficient use of resources and adherence to financial constraints.
- Reporting: Prepare and present regular project status reports to senior management, highlighting achievements, challenges, and proposed solutions.
Minimum Required Qualifications:
- Education: Bachelors degree in a relevant scientific or healthcare-related field.
- Experience: Minimum of 5 years in a healthcare environment, preferably within the pharmaceutical industry or related consulting services.
- Functional Expertise: At least 3 years of experience in Market Access/Health Economics and Outcomes Research (HEOR) functional planning, or alternatively, clinical development and regulatory planning.
- Project Management Skills: Demonstrated ability to manage complex projects, establish new procedures, and work under pressure.
- Communication Skills: Strong planning and communication skills, with previous experience in capability building and process change management.
Preferred Qualifications:
- Advanced Degree: MSc, MD, PhD, or PharmD in a healthcare, business, or economic discipline.
- International Experience: Experience in international healthcare ecosystems, including EU and ex-EU markets with established Health Technology Assessment (HTA) processes.
- Regulatory/HTA Submissions: Proven track record in the pharmaceutical sector regarding regulatory/HTA submissions and interactions.
- Cross-Functional Collaboration: Demonstrated success in working with cross-functional teams and cultural fit with the client
- Team Integration: Ability to integrate and collaborate in a diverse team, managing complex projects with multiple stakeholders.