Medical Writing Contractor
About The Position
We are seeking a Medical Writing Contractor to oversee the development and finalization of key clinical and regulatory documents. Specific responsibilities include, but are not limited to: Leading and contributing to the development of clinical and regulatory documents such as Clinical Protocols, Clinical Study Reports, Investigator Brochures, DSURs, Briefing Packages, INDs and Amendments, BLA/MAA documents, and regulatory responses according to company standards, processes, and timelines. This job description outlines the primary duties and responsibilities of the role; however, it is not intended to be all-inclusive. The scope of responsibilities may be modified, expanded, or adjusted at the discretion of the organization to meet evolving business needs.
Requirements
- Sc./M.S./Ph.D. or equivalent degree in a science or healthcare-related field combined with medical writing experience within the biopharmaceutical industry.
- Demonstrated ability to communicate and write clearly, concisely, and effectively.
- Aptitude for compilation, analysis, and presentation of data.
- Expert knowledge of AMA style, medical terminology, and clinical data analysis.
- Excellent interpersonal and influencing skills; ability to negotiate well and build good relationships with coworkers.
- Excellent technical skills and deep knowledge of Microsoft Word, Teams, and SharePoint.
- Expert knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards.
- Able to manage multiple projects in a fast‑paced environment with challenging deadlines and changing priorities.
- Experience authoring clinical regulatory documents.
- Ability to plan, manage, and optimize resources.
- Ability to assess workload and suggest prioritization to senior staff.
Responsibilities
- Leading and contributing to the development of clinical and regulatory documents such as Clinical Protocols, Clinical Study Reports, Investigator Brochures, DSURs, Briefing Packages, INDs and Amendments, BLA/MAA documents, and regulatory responses according to company standards, processes, and timelines.
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What This Job Offers
Career Level
Mid Level
Education Level
Ph.D. or professional degree
