Alphanumeric is hiring a MEDICAL EDITOR to work remotely.
- Collaborated with cross-functional teams globally on product projects from development to post-marketing.
- Contributed to writing projects and authored clinical, regulatory, and safety documents, enhancing scientific communication (DSURs, PBRERS, CSRs, IBs, protocols, IND submissions, patient narratives, and early phase publications).
- Collaborated with teams to incorporate changes effectively and efficiently into medical writing deliverables.
- Managed medical writing activities across departments. Coordinated document review, approval, and submission processes, aligning with timelines and regulatory requirements.
- Provided medical writing support for regulatory submissions, supporting BioCryst’s scientific communication and regulatory compliance.
- Collaborated with external medical writing vendors, ensuring adherence to SOPs and high-quality deliverables.
- Conducted Quality Control checks of medical writing deliverables prepared by other writers.
- Wrote 30+ medical narratives for patients with clinically significant events.
- Led trainings, provided team support, and created a user guide for ReadCube reference builder.
- Completed the Drug Information Association “Essentials of Safety Medical Writing” certification.
- Updated and maintained the BioCryst style guide and templates.
- Adhered to established regulatory standards, including ICH-E3 guidelines, company SOPs, standards, timelines, and templates when completing medical writing projects.
- Proficient in Vault RIM; launched templates, conducted author, review, and approval workflows
About Alphanumeric Systems Inc.
Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!
