RemoteLeaf Logo
Log in Sign up

Senior Medical Writer

3 hours, 29 minutes ago
United States
Full-time
Senior
Technical Writer
Technical Writing and Documentation
GCP
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 149

Description

  • Plan, write, edit, format, and perform QC review of clinical study documents, including protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives.
  • Lead document development from template creation through final approved version in collaboration with sponsors, vendors, and internal project teams.
  • Independently formulate key messages from clinical study data.
  • Author complex content using scientific and process knowledge.
  • Communicate clearly and concisely with internal and client teams, both in writing and verbally.
  • Contribute to the development and maintenance of medical writing processes, SOPs, templates, and work instructions.
  • Perform literature-based research to support writing activities.
  • Complete medical writing work in compliance with Precision style guides, SOPs, regulatory guidelines, and eCTD requirements.
  • Handle other assigned duties as needed.

Requirements

  • BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
  • 5+ years of experience as a medical writer in a sponsor and/or CRO setting.
  • Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
  • Clear understanding of applicable regulations, including ICH, FDA, and GCP.
  • Knowledge of clinical trial transparency requirements, including EudraCT and CT.gov.
  • Understanding of eCTD requirements for all phases of development.
  • Impeccable attention to detail and ability to complete writing assignments in a timely manner.
  • Ability to work effectively in a fast-paced environment with multiple high-priority projects, with no instruction on routine work and minimal instruction on new assignments.
  • Advanced degree (MS/PhD) preferred.
  • Oncology and/or rare disease experience, especially in protocol and CSR development, preferred.

Benefits

  • Salary range of $100,600 to $151,000 USD.
  • Eligible for a discretionary annual bonus.
  • Health insurance coverage.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

TechnologyAdvice

Content Editor, Tech

TechnologyAdvice 251-1K Media

TechnologyAdvice is hiring a remote-first Content Editor in the Philippines to manage DZone’s technical editorial and contributor-driven commercial content from publication through project closeout.

Philippines Full-time Mid Level Technical Project Manager Technical Writer
$1k-$1k
Agile HTML
2 hours, 17 minutes ago
Murmuration

Partner Education Specialist

Murmuration 11-50 Diversified Consumer Services

Murmuration is hiring a Partner Education Specialist to manage Help Center content and training knowledge for partners and internal teams supporting community organizing and civic engagement tools and data.

United States Full-time Mid Level Instructional Designer Technical Writer
$110k-$110k
Confluence
3 hours, 29 minutes ago
Intetics

1005 | Content Research Specialist (Entry Level, Training Provided)

Intetics 1K-5K Internet Software & Services

Intetics Inc. is hiring an Incident Editorial Specialist for a part-time, remote role supporting real-time traffic incident editing for a global mapping platform in Lviv and Kyiv.

Ukraine Part-time Entry Level Technical Writer
3 hours, 44 minutes ago
ARETUM

ArchivesSpace Developer - Junior

ARETUM Construction & Engineering

Aretum is seeking a Junior ArchivesSpace Developer to support federal client work implementing and configuring archival management systems within a remote consulting environment.

United States Full-time Junior Software Engineer Technical Writer
Agile CSS GitHub GitLab HTML Java JSON MySQL Ruby on Rails Scrum Solr XML
3 hours, 44 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers