Senior Medical Writer – Structured Content Authoring

Medical writerMedical writerFull TimeRemoteTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

38 days ago

Salary

Not specified

Bachelor DegreeEnglishGoogle Cloud Platform

Job Description

• Configure and maintain SCA platform settings to support medical writing and regulatory workflows. • Customize templates, metadata fields, and document structures for compliance and efficiency. • Implement and validate workflow configurations for review, approval, and version control. • Ensure integration of SCA with other enterprise systems (e.g., PleaseReview, Veeva RIM). • Conduct functional testing and troubleshoot configuration issues. • Maintain detailed documentation of configuration changes for audit readiness. • Collaborate with internal teams to gather requirements and translate them into technical solutions. • Provide user training and support on SCA features and best practices. • Offer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform. • Ensure all configurations comply with regulatory standards and company SOPs.

Job Requirements

  • Proven experience with SCA platforms.
  • Background in medical writing or strong familiarity with regulatory documentation processes.
  • Hands-on experience in content creation, review, standardization, and management within a structured content platform.
  • Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents.
  • Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform.
  • Strong problem-solving skills and attention to detail.
  • Familiarity with compliance and audit requirements in a GxP environment.
  • Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
  • Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
  • Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.

Benefits

  • Impactful Work: Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide.
  • Global Collaboration: Work with diverse teams across the globe in a dynamic, innovative environment.
  • Career Growth: Access to professional development programs, mentorship, and opportunities for advancement.
  • Flexibility: Enjoy the benefits of a fully remote role with a healthy work-life balance.
  • Inclusive Culture: Be part of a company that values diversity, integrity, and collaboration.

Related Categories

Related Job Pages

More Medical writer Jobs

Medical Writer – Publications

Red Nucleus

Learning & Development, MedComms, Market Access, Video Capture Software for Clinical Trials, Regulatory Advisory

Medical writer39 days ago
Full TimeRemoteTeam 501-1,000H1B Sponsor

Medical Writer responsible for writing and editing scientific communications

United States

Associate Director, Clinical Documentation, Integrity

Guidehouse

Solving big problems, building trust in society, and empowering our clients to shape the future.

Medical writer40 days ago
Full TimeRemoteTeam 10,001+Since 2018H1B Sponsor

Associate Director managing clinical documentation and integrity for healthcare reimbursements.

United States
$135K - $225K / year

DME Documentation & Criteria Reviewer

Tennr

Tennr reads documents from incoming faxes passing through healthcare practices and automates essential tasks like scheduling and qualifying patient visits. By automating that paperwork with Tennr, practices receive more patient referrals and reduce billing errors by 98%, significantly growing revenue.

Medical writer40 days ago
Full TimeRemoteTeam 69Since 2021

This role involves reviewing clinical documentation, flagging incorrect determinations, and analyzing insurance coverage policies to ensure compliance. It requires expertise in DME and working closely with internal teams to improve qualification logic.

United States
$58K - $65K / year
Full TimeRemoteTeam 11-50H1B No Sponsor

Senior Clinical Documentation Specialist providing CDI support across Ascension’s multi-market system

United States
$82.8K - $115.5K / year