Please note that due to the COVID-19 pandemic, this position is currently remote however once we return to the office this position will be based in one of our office locations ( Durham NC, Exton PA, or Broomfield CO).
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
- 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
- Experience authoring clinical study reports, regulatory documents, and manuscripts is preferred
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.
