Associate Vice President, Head of Medical Writing

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 Chief Development Officer the Associate Vice President, Head of Medical Writing will play an essential role within Rocket’s gene therapy programs, working with clinical, regulatory, and CMC teams to optimize the authorship of material related to the development of our AAV and LV programs. The ideal candidate will have extensive experience leading and developing medical writing groups, and keen awareness of successful strategies for development of clinical protocols and supporting documents, and the multiple components of health authority submissions including those pertaining to CMC for innovative therapeutic modalities.  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, build, and lead the medical writing capability within an innovative and growing organization dedicated to the development of transformative therapies for serious disorders.

Responsibilties:

    • Lead and develop a growing team of medical writers, enabling the group to support multiple concurrent programs ranging from pre-IND/IND submission phase through registrational trials and BLA submission, ensuring that the CMC and clinical elements of INDs, protocols, and health authority submissions adhere to the highest standards and are completed within timelines.
    • Work with clinical, regulatory, and CMC teams to establish optimal interfaces to enable efficient and thorough authorship/revision of key technical documents, and oversight of diverse regulatory submission documents comprising clinical and CMC modules to support BLA filing
    • Establish systems and best-practices for training multidisciplinary colleagues participating in document authorship Lead cross-functional process improvement initiatives on document standards, template development, and document processes.
    • Build and ensure maintenance of knowledge base to improve the overall medical content of documents and ensure adherence to multinational regulatory standards
    • Collaborate effectively across Clinical, Regulatory, Quality, Biostatistics, Data Management and CMC in a team environment.

Requirements:

    • Minimum BS in Biological Sciences or related field with 20 years of experience
    • Medical writing leadership 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
    • Extensive experience with IND and BLA packages, primary authorship of key components (i.e. CSRs) and mentorship of colleagues contributing to these submissions
    • Experience leading a team of Medical Writers
    • 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.
    • Excellent 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.