Nuventra is seeking a Scientific/Medical Writer to support our expanding clientele. The successful candidate will act as a lead writer on a diverse set of scientific, regulatory, and technical documents. This is an early career (but not entry level) position. As such, prior scientific and/or medical writing experience is expected.

Responsibilities: 

  • Author and review scientific, regulatory, and technical documents, including clinical protocols, clinical study reports, pharmacokinetic/pharmacodynamic reports, analysis plans, drug development plans, Investigational New Drug applications (INDs), marketing applications, Investigator Brochures, FDA meeting requests and briefing documents, scientific manuscripts, and others
  • Perform literature searches/reviews and write summary reports of findings
  • Maintain a detailed knowledge of FDA and ICH guidelines and other regulations, including those related to the content and format of regulatory documents 
  • Develop/maintain adequate proficiency with clinical pharmacology concepts and drug development principles
  • Work in a team environment with other medical writers and drug development experts to write and finalize deliverable documents
  • Function as a flexible resource for clients and internal staff
  • Actively participate in meetings with both internal and client teams
  • Contribute to internal process development, template generation and maintenance, and training initiatives

Qualifications: 

  • MS or PhD in a scientific field, or PharmD
  • At least 2 years of medical or scientific writing experience, preferably in an industry setting (pharma, biotech, consulting). Preference will be given to candidates with demonstrated experience authoring clinical study reports or other regulatory documents (e.g., eCTD nonclinical, clinical, or quality/CMC summaries) in support of FDA, EMA, or similar regulatory body submissions
  • Team player who is comfortable working simultaneously across multiple dynamic project teams
  • Ability to prioritize and perform required tasks independently and with limited guidance
  • Ability to identify and summarize important information from source documents, including subject matter that may be outside the writer’s prior experience
  • Ability to communicate complex scientific concepts and technical details to team members, clients, and regulatory authorities
  • Flexibility to address urgent requests quickly and efficiently within tight deadlines while maintaining an exemplary level of quality
  • Comfortable being a client-facing member of Nuventra’s project teams

Benefits and Perks:

  • Great Medical, Dental, and Vision plans (Vision is covered 100% for all employees and their families)
  • 401(k) and student loan matching
  • Flexible work environment including weekly remote work options
  • Paid childbirth and childcare leave
  • Paid 5 week sabbatical after 5 years of employment
  • Stocked kitchen with drinks, goodies, and snacks
  • Frequent company and team-building events
  • Monthly gym reimbursement
  • 8 hours of paid volunteer time-off

Diversity is a key to success. We are an equal opportunity employer and welcome applicants of all backgrounds, experiences, and perspectives.

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