Director, Medical Writing – Regulatory

Cranbury, NJ /
Clinical Development – Clinical Development /
Full Time
/ Hybrid
Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues.  We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Reporting to the Head of Medical Writing, the Director, Medical Writing – Regulatory will play an essential role within Rocket’s gene therapy programs, working with both regulatory and clinical teams to optimize the authorship of material related to the development of our AAV and LV programs, with emphasis on BLA (or European equivalent) submissions. The ideal candidate will have experience generating documents and coordinating modules for health authority submissions, including key clinical study and summary reports, in addition to experience with IND applications, clinical protocols and supporting documents such as investigator brochures, health authority annual reports and DSURs.  Experience with cell- or gene-based or other highly complex therapies and with multi-systemic, life-threatening disorders is essential. This is an opportunity to establish and build the regulatory medical writing capability within an innovative and growing organization dedicated to the development of transformative therapies for serious disorders.

Responsibilities:

    • Work with regulatory and clinical teams to write and/or revise technical documents and oversee all report writing activities for projects across regulatory submission modules to support BLA filing
    • Provide appropriate background information, guidance, and training to colleagues participating in document authorship
    • Ensure consistency across documents and improve document quality
    • Review statistical analysis plans and data tables/listings and figures and ensure appropriate incorporation into reports
    • Build and maintain knowledge base to improve the overall medical content of documents
    • Drive the clinical study report and module writing process by ensuring that report contributors understand their responsibilities, timelines are developed and maintained and that relevant activities are completed.
    • Collaborate effectively across Clinical, Regulatory and Quality in a team environment.

Requirements:

    • Minimum BS in Biological Sciences or related field with 12 years of experience
    • Experience with novel therapeutic agents and therapies directed at complex, multi-systemic disorders; experience with cell therapies and/or gene therapies is preferred
    • Working knowledge of US FDA and European regulatory requirements
    • Experience with BLA packages, and primary authorship of key components (i.e. CSRs)
    • Ability to operate in a fast-paced, collaborative environment
    • Ability to perform work with a high degree of accuracy and quality while working under tight deadlines.
    • Strong verbal, written, and interpersonal communications skills with the ability to explain complex concepts with clarity and simplicity.
    • Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) and Adobe Acrobat Professional.
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.