Senior Medical Writer – Clinical Focus

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Assist in the creation of clinical and regulatory documents across various service lines.

• Act as project lead for smaller initiatives, engaging directly with clients.

• Support more complex projects as part of a larger delivery team.

• Lead internal project teams while anticipating the impact of writing standards on health authority approval or acceptance.

• Create submission-level documents.

• Produce clinical documents including Clinical Study Reports, Investigator Brochures, protocols, ISS, and ISE.

• Integrate data from multiple sources and documents to formulate summary reports.

• Conduct or facilitate a CRM and guide project teams to achieve consensus.

• Articulate ideas and recommendations using logical reasoning while constructively addressing opposing perspectives.

• Build and maintain professional client relationships to foster business connections and stay updated on industry trends.

• Recognize and implement effective work practices to promote consistent performance.

⛳️ Requirements

• Bachelor’s degree.

• Over 3 years of experience in regulatory writing or equivalent experience in clinical documentation.

• Familiarity with regulatory authority guidelines and requirements.

• Experience in developing submission-level documents.

• Proven experience in creating Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE.

• Intermediate proficiency in Microsoft Word, including editing features, table creation and modification, and figure insertion.

• Understanding of document management techniques.

• Strong grasp of the document creation process and the drug development lifecycle.

• Capability to synthesize data from various sources and documents.

• Skill in conducting or leading a CRM and guiding a project team to consensus.

• Ability to persuade others with logical arguments and respond constructively to differing views.

• Proficient in developing professional client relationships.

• Competence in identifying and establishing effective work practices.

🏝️ Benefits

• Remote working options.

• Flexible time off policies.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement opportunities.

• Retirement plan options.

• Eligibility for applicable bonuses.