We are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents with expertise and in-depth knowledge of analysis and presentation of scientific and clinical data to produce high-quality documents.
As the initial full-time Medical Writer employee, you will lead the development of Medical Writing departmental processes, procedures, and tools, providing the framework to deliver high-quality documentation. As an integrated team member, you will contribute to cross-functional working groups as needed to facilitate efficient development and finalization of regulatory and clinical documents for submissions.
About The Team
As a member of this team, you will feel the excitement, passion, and pure joy that comes from being part of an innovative company with a focused mission.
Skills and Competencies
Ability to be able to command the attention and lead higher level managers and senior subject matter experts.
Proactive and be able to drive the document to its conclusion.
You know what great medical writing looks like, leveraging your scientific knowledge, collaborative skills, and team spirit to produce high-quality strategic writing.
You enjoy working closely with the project teams, particularly Clinical Operations, Regulatory Affairs, and clinical and nonclinical development teams, to manage all aspects of clinical/regulatory document preparation, including protocols, CSRs, Investigator Brochures, and other regulatory submission documents
Required Education and Experience
Bachelor's degree at a minimum, preferably a PhD in a Life Science area (or equivalent experience) with 5+ years of regulatory medical writing experience.
Outstanding written and verbal communication skills.
Well-organized with significant knowledge of drug development, clinical research, study design, biostatistics, and the regulatory environment, with a detailed understanding of requirements for the preparation of key clinical and regulatory documents.
Independently motivated, and with good problem-solving ability; able to work with multiple contributors, adjusting to the changing needs of the development programs to produce a final unified document.