Senior Medical Writer I at FHI 360

Summary of The Position:

The Senior Medical Writer is tasked with the writing of study-related documentation for clinical projects undertaken by the Company, in accordance with ICH-GCP and local legal requirements, European, FDA, and other international guidelines, as well as Company (and client, if applicable) SOPs. The Senior Medical writer will complete scientific/medical writing assignments, as required for clinical projects undertaken by the Company, taking a lead role with limited guidance from senior members within the team. The Senior Medical Writer will be responsible for preparing assigned documents, which includes but is not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews and communicating directly with the client, as well as coordinate information and data inputs from team members when preparing study documents. The Senior Medical Writer is responsible for independently planning and organizing workload for assigned projects and tasks, identifying project needs, tracking timelines, and implementing customer requests.

Essential Functions:

• Write and/or coordinate the writing of appropriate sections of:
• Protocols and Protocol Amendments (including full synopsis and document development, synopsis and document development assistance, and synopsis and document review).
• Informed Consent Forms
• Clinical study reports (including full, interim and/or final, abbreviated, synoptic, addenda, etc.) including Appendices and safety narratives, and final collation and publishing of the final documents.
• Review and provide input into the SAP and mock and draft TFLs.
• Investigator’s Brochures.
• Annual Safety Update Reports (including DSURs, PSURs etc.).
• Publications/Manuscripts.
• All contracted submission-ready documents as per Regulatory Authority requirements (e.g., Modules 1 through 4 [administrative, quality, nonclinical, and clinical documents])
• Development and/or review of any other document in accordance with contractual requirements.
• Maintain quality control, formatting, and editing of assigned documents.
• Perform quality control of documents assigned to other Medical Writings (including reviewing data, data integrity, interpretation, and ensuring formatting and style guides as per FHI Clinical standards (or client if requested) and ultimate quality standards per industry and FHI Clinical requirements.

Knowledge, Skills, and Abilities:

• Mindset for learning.
• Expert scientific/medical writing skills.
• Uncompromising attention to detail and the ability to think analytically.
• Able to communicate in English, effectively and accurately, both orally and in writing.
• Effective time management skills.
• Ability to prioritize workload.
• Excellent interpersonal skills and problem-solving ability.
• Diplomatic conflict management.
• Effective organizational and negotiation skills.
• Strong computer skills, including:
• Microsoft Word
• Microsoft Teams, including Sharepoint sites through Teams and ability to work collaboratively on documents.
• Smartsheet or other timeline management systems.
• Ability to learn and improve on appropriate software, as necessary.
• Proficient knowledge of human physiology.
• Basic knowledge of pharmacology areas.
• Proficient knowledge of therapeutic areas.
• Proficient knowledge of all relevant Company SOPs, ICH-GCP and local legal requirements, European, FDA, and other relevant international guidelines applicable to clinical research.

Position Requirements

• Education: Bachelor’s or higher graduate degree (or its international equivalent) in a scientific-/medically-related field.
• Preferred Job-related Experience: A minimum of 3 years of demonstrated Regulatory Medical Writing experience. Adequate experience in clinical research.