Package Insert Development (Cell and Gene Therapy)

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This is a contract consulting position.

Location: Remote (with occasional travel as needed)

Overview:

We are seeking a skilled Consultant to lead the development of a package insert for a novel cell and gene therapy product. This role demands extensive experience in the life sciences industry, with specific expertise in the regulatory and technical requirements for package insert creation. The consultant will be responsible for drafting the document from inception, ensuring regulatory compliance, and coordinating with cross-functional teams to deliver a high-quality final product.

Key Responsibilities:

• Document Development:
• Draft the package insert from scratch, incorporating all necessary product-specific information such as indications, usage, dosage, administration, warnings, and adverse reactions
• Ensure the package insert is accurate, comprehensive, and aligned with regulatory standards (e.g., FDA, EMA)
• Collaborate with internal subject matter experts (SMEs) to gather data and validate content
• Regulatory Compliance:
• Research and incorporate applicable regulatory guidelines to ensure the package insert meets the requirements of regulatory authorities
• Address label-specific requirements, including formatting, font size, and layout as per regulatory standards
• Ensure alignment with the cell and gene therapy product’s approved labeling and marketing authorization
• Content Quality Assurance:
• Implement quality control measures to ensure clarity, consistency, and accuracy in the document
• Review and incorporate feedback from internal teams, regulatory affairs, and external reviewers
• Stakeholder Collaboration:
• Work closely with medical, regulatory, legal, and marketing teams to ensure the package insert aligns with the overall product strategy
• Manage stakeholder expectations and facilitate approvals from relevant teams and regulatory bodies
• Project Management:
• Develop a project plan for the package insert creation process, including timelines and deliverables
• Track progress and ensure timely completion of the document
• Provide regular updates to stakeholders on project milestones

Qualifications:

• Advanced degree (PharmD, MD, PhD, or equivalent) in Life Sciences, Pharmaceutical Sciences, or a related field
• Minimum of 5 years of experience in regulatory affairs, medical writing, or label development within the life sciences industry
• Strong knowledge of regulatory requirements for package inserts, particularly for cell and gene therapy products
• Proven experience drafting package inserts or similar regulatory documents
• Familiarity with FDA and EMA guidelines and submission processes
• Exceptional written and verbal communication skills, with attention to detail and accuracy
  
  

Key Competencies:

• In-depth understanding of scientific and regulatory language
• Ability to synthesize complex technical information into clear and concise language
• Strong project management and organizational skills
• Collaborative mindset with the ability to work effectively across teams
• Proficiency in managing multiple tasks and meeting deadlines in a fast-paced environment
  
  

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