10+ years biotech pharmaceutical industry experience
Manage staff of up to 60 medical writers
Understanding of global clinical trial disclosure regulations
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Merck KGaA Darmstadt Germany is seeking a Disclosure Analyst to oversee clinical trial data registration, results postings, and compliance with global disclosure regulations. The role involves managing a large team of medical writers and specialists, requiring extensive experience in the biotech/pharmaceutical industry and strong project management skills.
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Job Summary
The role involves overseeing clinical trial data registration, results postings, and redaction operations in alignment with global regulations.
The successful candidate will manage a large team of over 60 medical writers and specialists to complete all authoring and approval activities.
The position offers a competitive salary range of $243,500.00 to $383,300.00 along with comprehensive benefits including bonus eligibility and retirement plans.
Matching Summary
Match Score: 75
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Merck KGaA Darmstadt Germany is seeking a Disclosure Analyst to oversee clinical trial data registration, results postings, and compliance with global disclosure regulations. The role involves managing a large team of medical writers and specialists, requiring extensive experience in the biotech/pharmaceutical industry and strong project management skills.
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Salary
Base: $243,500.00 - $383,300.00; Bonus/Equity: Bonus eligibility and long term incentive if applicable; Benefits: Health care, retirement, paid holidays, vacation, and sick days
Skills & Requirements
Must-have
10+ years biotech pharmaceutical industry experience
Manage staff of up to 60 medical writers
Understanding of global clinical trial disclosure regulations
Experience with FDAAA and EudraCT processes
Strategic leadership in health literacy
Nice-to-have
Strong relationships with Legal and Communications
Proven track record of innovation and leadership
Ability to inspire passion for health equity
Experience working with oncology and vaccine confidence areas
Key Requirements
Bachelor's degree required; Master's preferred
10+ years of biotech/pharma industry experience
People management skills for large teams
Project management skills focusing on quality
US work authorization required (implied by location)