Praxis Precision Medicines is a clinical-stage biopharmaceutical company committed to transforming genetic insights into breakthrough therapies for central nervous system (CNS) disorders. Our mission is to alleviate the burden of complex brain disorders through innovative treatments that address neuronal imbalances. At Praxis, we uphold the core values of Trust, Ownership, Curiosity, and Results, fostering a collaborative and inclusive work environment.
Job Responsibilities
As a Medical Writer at Praxis, you will play a pivotal role in developing high-quality, regulatory-compliant documents that support clinical trials and regulatory submissions. Reporting to the Associate Director, Medical Writing, your responsibilities include:
- Preparing and managing medical and regulatory documents, serving as the lead writer or collaborating with external writers when necessary.
- Drafting and reviewing documents for regulatory submissions, including INDs, NDAs, MAAs, protocols, investigator brochures, clinical study reports, briefing documents, and health authority responses.
- Collaborating with cross-functional teams, including Clinical Pharmacology, Toxicology, Research, Regulatory Affairs, Biostatistics, and Quality Control, to deliver accurate and scientifically robust content.
- Supporting clinical trial transparency initiatives, including clinical trial registration and results postings on platforms like ClinicalTrials.gov and EudraCT.
- Contributing to departmental development by assisting with templates, style standards, and standard operating procedures to ensure consistency and quality.
- Ensuring adherence to relevant SOPs and internal best practices.
Qualifications
To excel in this role, candidates must meet the following qualifications:
- Education: Bachelor’s degree in a scientific discipline is required; advanced degrees and experience in CNS and rare diseases are advantageous.
- Experience: At least 3 years of medical writing experience in a sponsor or CRO setting. Familiarity with medical writing systems such as Veeva RIM is a plus.
- Certifications: AMWA certification is preferred.
- Knowledge: Comprehensive understanding of drug development, clinical study conduct processes, ICH guidelines, and FDA/EU regulations.
- Skills: Excellent verbal and written communication skills, attention to detail, and organizational abilities.
Key Skills
- Self-motivation and the ability to work autonomously.
- Strong interpersonal skills to collaborate effectively across teams.
- Proficiency in medical writing tools and systems.
- Commitment to delivering high-quality results in a fast-paced environment.