An exciting early-phase biotechnology company is looking for a contract medical writer to join their Regulatory Affairs team. To give a little more context on this organization, they are at the Series B funding stage, and they are looking to move into the clinic. They have a therapeutic and companion diagnostic pipeline, and are working within the autoimmune therapeutic area. They have an exciting pipeline and technology they are pioneering and are seeking a passionate medical writer to join their team.
As far as the time commitment per week for this contract medical writer position, they are ideally looking for someone who is able to work 10-25 hours/week on their team.
The responsibilities for the role are as follows:
Take on the role of the lead medical writer, contributing to various clinical documents used for clinical and regulatory purposes, such as clinical protocols, clinical study reports, investigator brochures, and other documents submitted for regulatory review.
Facilitate collaboration among cross-functional teams to generate scientifically accurate and high-quality documents.
Develop and coordinate timelines to ensure the prompt completion of clinical writing projects.
Oversee timelines and maintain communication with team stakeholders to stay updated on expectations, milestones, and deliverables.
Take charge of significant workstreams that involve collaboration across different departments.
Offer assistance in quality control for complex clinical documents.
Some of the specific qualifications are as follows:
7+ years in the industry as a medical writer.
Experience with drug and companion diagnostic products preferred.
Clinical/Regulatory writing experience in drug development AND medical devices.
Experience working at a smaller biotechnology company is preferred.
Demonstrated project and people management experience.
If this sounds like something that would be interesting to yourself or someone in your networl, please reach out! Additionally, if you are interested in hearing more about similar positions, please feel free to reach out!