The successful candidate will be responsible for:

• Independently planning and leading complex audits of material suppliers, service providers, and Pfizer Country Offices
• Participating in audits of low-complexity commercial or clinical manufacturing sites and contract manufacturers
• Performing initial and routine audits, and managing and leading with minimal oversight
• Leveraging AI tools to support targeted audit preparation and execution
• Engaging with complex audits, including process audits, or serving as a reviewer of low-complexity, outsourced audits
• Supporting and executing quality programs related to functional areas, specific vendor entities, and/or assessments
• Applying GMP working knowledge to resolve issues based on relevant SOPs, GMP GDP regulations/standards, and local regulations and standards
• Collaborating with RQA colleagues on cross-GxP audit plans as required
• Managing multiple stakeholders to synthesize feedback and take action with support from the Manager

The ideal candidate will have:

• A BS in pharmaceutical or natural sciences, or equivalent
• Advanced knowledge and understanding of global regulations and international standards
• Comprehensive working knowledge of business concepts and quality operations
• Ability to think critically and identify areas of greatest risk
• Proficient organizational and project management skills
• Technical writing skills
• Ability to identify trends within data and apply insights to make recommendations
• Specialization in at least one conventional technology (e.g., API, solid oral dosages)

Preferred qualifications include:

• 5-7 years of experience in operational or auditing roles
• Working knowledge of data analytics and interpretation capabilities
• Expertise in vendor audits and at least one technology area (e.g., MDCP, sterile biologics, small molecules, GDPs)
• Ability to function autonomously in a matrix model and in a team environment
• Fluency in both Japanese and English languages

This is a field-based position that requires walking, observing, and assessing quality and compliance risks. The successful candidate will be able to travel up to 40% of the time, including domestic and international travel.

Job Data by YubHub.

You will collect, analyze, and edit legal information, such as statutes, case law, legal articles, and legal news, and link related information on the database so that its users can find what they need quickly and accurately.

Key Responsibilities:

• Editing of Database: Collecting, selecting, editing, updating, and otherwise maintaining legal information contained in the database, such as statutes, case law, e-books, law journals, legal articles, and legal news.
• Enhancement of Content Value: Classifying and organizing the information contained therein, linking related information, adding metadata that improves search, and otherwise improving the database to make it easier to use.
• Management of Quality: Ensuring the integrity of the database by reviewing its content prior to publication, implementing quality standards, and continuously improving them.
• Collaboration with Authors and Vendors: Collaborating with a diverse range of authoring practitioners, such as lawyers and academics, external editors, professional bodies, and government agencies.
• Management of Projects: Leading assigned projects and ensuring the quality of work delivered by external authoring practitioners.
• Process Improvement and Use of Generative AI: Contributing to improving editorial systems, standardizing procedures, and increasing efficiency with generative AI tools.
• Contribution to Development of New Content: Applying an editorial perspective to the development of content for new products and the enhancement of existing products.
• Collaboration Across Teams: Collaborating closely with the product, technology, sales, and overseas editorial teams to enhance the quality of content.

Required Qualifications:

• A law degree, or equivalent legal knowledge gained through legal practice or legal editing.
• The ability to accurately interpret the structure of statutes and case law.
• Japanese proficiency, sufficient to read, interpret, and edit Japanese statutes, case law, and legal commentary.
• Excellent writing and proofreading skills in Japanese.
• Strong communication skills to earn the trust of everyone involved.
• The ability to pay close attention to detail and to meet deadlines.
• English language skills at a conversational level.
• Fundamental computer skills, including proficiency in editorial systems and the use of Microsoft Word, Excel, and PowerPoint.
• A positive attitude toward the adoption of new tools and technologies, such as generative AI.

Preferred Qualifications:

• A Juris Doctor (JD) from a Japanese law school, or a master's degree or higher in law.
• Legal qualifications, such as passing the Japanese bar examination or registration as a judicial scrivener, administrative scrivener, or patent attorney.
• Editing experience at a legal publisher or legal information service company.
• Experience commissioning content and collaboration with external practitioners.
• Proficiency in the management of structured documents, such as XML.
• Proficiency in leveraging generative AI tools for editorial operations.
• Experience managing competing priorities and resolving editorial issues under publication deadlines.

What's in it For You?:

• Hybrid Work Model: Flexible hybrid working environment.
• Flexibility & Work-Life Balance: Supportive workplace policies.
• Career Development and Growth: Culture of continuous learning and skill development.
• Industry Competitive Benefits: Comprehensive benefit plans.
• Culture: Globally recognized, award-winning reputation.
• Social Impact: Opportunities to make an impact in the community.

Job Data by YubHub.