Medical Writing Team Lead
1 week ago
Unlock Your Potential as a Medical Writing Team Lead at Eisai
Eisai, a leading pharmaceutical company, is breaking through in neurology and oncology with a strong emphasis on research and development. Our mission is to satisfy unmet medical needs and increase the benefits healthcare provides to patients, their families, and caregivers.
We're seeking a highly-motivated Associate Director, Medical Writing who will be responsible for providing direction to other staff/contractors, ensuring timely completion of clinical documentation across various compounds' life cycle management. This role involves acquiring knowledge of complex programs, managing outsourcing of document preparation, and working with functional areas to obtain source materials.
Key Responsibilities:
- Prepare and direct writing of PCSs, protocols, and protocol amendments
- Lead the preparation of clinical sections of submission documents, such as briefing books, Global Investigator Brochures, and annual regulatory reports
- Liaise with other functional areas to develop document standards and structure
- Implement document quality controls, standards, and best practices
Requirements:
- Bachelor's degree required, Master's preferred
- Minimum 8-10 years medical writing experience in an industry setting, with specific experience in the therapeutic area
- Must have participated in or led a major marketing application submission
- Strong critical thinking and problem-solving skills
Benefits:
- Competitive salary range: $149,200 - $195,800
- Eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan
- Employee benefit programs available, including health insurance, retirement plans, and more
About Us:
Eisai is an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination against persons because of disability, including disabled veterans. We participate in E-Verify and are an Equal Employment Opportunity Employer.
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