Nuventra is looking for medical writers to support our expanding clientele. Primary responsibilities include performing, under minimal supervision, medical, scientific, and regulatory writing related for investigational drugs (small molecules and biologics). This position has a high potential for growth with a path that is dictated in large part by the professional goals of the individual.
- Authoring, reviewing, QC, and formatting of clinical protocols, clinical study reports, clinical pharmacokinetic/pharmacodynamic reports, statistical analysis plans, PK/PD analysis plans, clinical pharmacology strategic plans, full INDs, clinical pharmacology and non-clinical sections of NDAs/BLAs, full NDAs/BLAs (all CTD modules), full ANDAs, Investigator Brochures, FDA briefing packets, peer-reviewed manuscripts, and other clinical, scientific, and regulatory documents as needed
- Maintain a detailed knowledge of FDA and ICH guidelines and regulations related to the content and format of documents
- Work in a team environment with drug development experts to write and finalize deliverables for submission to clients
- Perform literature searches/reviews
- Review and QC of data listings and study data to ensure consistency and scientific accuracy
- Provide strategic consulting services to clients
- Management of projects and timelines internally and for clients
- Seek ways to improve efficiency and work flow as appropriate
We are seeking an individual with an advanced degree (MS or PhD) in a medical/scientific field and 0-2 years of experience in medical/scientific writing on pharmaceutical or biotechnology projects. Experience with early phase drug development, Phase 1 studies, pharmacokinetics, and pharmacodynamics is a plus but not required. The qualified candidate must have the ability to work independently with little supervision to produce key deliverables for clients.
To be considered for this position please complete the form below and attach a CV and cover letter (if desired).