Package Insert Development Cell and Gene Therapy
Package Insert Development Cell and Gene Therapy
Posted on :
11-04-2025
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1 Vacancy
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Job Description
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in@medvacon. If you receive a message that seems suspicious or is not from our official domain please report it immediately toemailprotected.
This is a temporary contracted 1099 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 crossfunctional teams to deliver a highquality final product.
Key Responsibilities:
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in@medvacon. If you receive a message that seems suspicious or is not from our official domain please report it immediately toemailprotected.
This is a temporary contracted 1099 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 crossfunctional teams to deliver a highquality final product.
Key Responsibilities:
- Document Development:
- Draft the package insert from scratch incorporating all necessary productspecific 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 labelspecific requirements including formatting font size and layout as per regulatory standards.
- Ensure alignment with the cell and gene therapy products 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.
- 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.
- Indepth 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 fastpaced environment.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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