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Orca Bio
Role Summary:
- The Clinical Trial Transparency and Disclosure Lead is an integral member of the Medical Writing department.
- The role provides strategic and operational expertise for disclosing clinical regulatory documents for Pfizer-sponsored trials.
Role Responsibilities:
- Provide subject matter expertise to develop global strategies for clinical document disclosure.
- Manage planning, preparation, and quality of disclosures, overseeing vendors and developing performance metrics.
- Lead standard processes and technology solutions for compliance with disclosure requirements.
Basic Qualifications:
- Bachelor's degree in medical or life science, with extensive pharmaceutical or biotech experience.
- Experience with regulatory medical writing and EMA Policy 70 submissions is required.
- Excellent project management, interpersonal, and negotiation skills.
Pfizer
Pfizer is a global biopharmaceutical company dedicated to discovering and developing innovative therapies. As a large multinational employer with a culture of individual ownership, it employs tens of thousands of people and fosters a collaborative and inclusive environment.