Reporting to the Chief Medical Officer, the Medical Writer/Medical Communications Manager will support Rocket’s gene therapy programs through interfacing with both clinical and regulatory teams to support the authoring of material related to the development of our AAV and LVV programs. The ideal candidate will have experience generating documents for health authority submissions (ie INDs, investigator brochures, CTAs) as well as protocols and publications/presentations for cell- or gene-based therapies for rare and life-threatening hematopoietic disorders.
- Work with regulatory and clinical teams to write and/or review technical documents and oversee all report writing activities for projects across regulatory submission documents, protocols, and amendments as well as publications and presentations
- Write and/or review submissions to peer-reviewed journals, scientific meetings and presentations
- 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 ensure appropriate incorporation into reports
- Build and maintain knowledge base to improve the overall medical content of documents
- Drive the clinical study report writing process by conducting or ensuring report contributors understand their responsibilities; timelines are developed and maintained; activities are completed.
- Collaborate effectively across Clinical, Regulatory and Quality in a team environment.
Education & skills
- Minimum BS in Biological Sciences or related field with 4+ years of experience
- Background in the therapy of complex, multi-systemic disorders, cell therapies and/or gene therapies, preferably AAV or LVV-based
- Working knowledge of US FDA and European regulatory requirements
- Ability to operate in a fast-paced, collaborative environment
- Perform work with a high degree of accuracy and quality while working under tight deadlines.
- Demonstrate 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.
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs.
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to email@example.com