Manager, Medical Writer

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!

The Manager of Medical Writing is responsible for the smooth functioning of all medical writing projects for clients and project teams through management of internal staff and the medical writing process. This role also maintains optimal department processes, implements project-specific strategies, and assists with the development and implementation of department strategies to increase productivity and quality.


As a Manager, Medical Writing You Will... 

• Assist with the oversight of medical writing personnel, including hiring personnel, managing personnel matters, and conducting performance evaluations for relevant staff.Be involved in training medical writing staff regarding applicable regulatory guidelines and medical writing practices.
• Serve as the lead Medical Writer on projects. As the lead Medical Writer, draft and finalize documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include, but are not limited to, clinical study reports, study protocols, investigator’s brochures, and manuscripts.
• Assist with resource allocation and with the development of business proposals related to Medical Writing functions. Work with Project Managers to develop timelines and resource plans for the production of clinical documents.
• Review statistical analysis plans and case report forms as required. Perform “peer” and quality control (QC) review of clinical study reports and clinical sections of regulatory submissions written by other medical writers. Keep management informed on progress of documents and other project related information, assist management in projecting resources, and perform administrative duties as requested.

Experience & Minimum Requirements:

• Bachelor’s degree required.
• At least 10 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting preferred. At least 5 years of line management experience preferred.
• Some applied training relevant to the clinical trials or health research environment.
• Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

Automated Decision Making

All applicants are reviewed by a member of the Veristat Talent Acquisition team and therefore we don’t have an automotive decision-making process.