Your Role:

The Senior Medical I Writer will have the primary responsibility for leading the preparation of all clinical trial documents including protocol synopses, full protocols, and clinical study reports, as well as clinical and nonclinical summary modules for INDs, NDAs, regulatory documents such as briefing books etc. May also develop scientific publications and other external documents such as scientific abstracts and manuscripts. Leads execution of medical writing projects coordinating the contributions of the cross functional team, managing timelines, Veeva flows to ensure the timely and efficient delivery of study documents.

Location Classification – Hybrid:

This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid​

​​​Essential Duties and Responsibilities:

• Leads development of clinical and nonclinical documents that are submitted to regulatory authorities including but not limited to investigator brochures, study protocols, model informed consents, interim and final clinical study reports (CSR), module 2 documents, and regulatory documents such as briefing books etc.
• Produces complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and dossiers.
• Responsible for positioning information and data for presentation of clinical, pharmacokinetic, pharmacodynamic and statistical written materials. Leads compilation of CSR appendices including data displays and clinical narratives.
• Provides detailed medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
• Ensures document content and style adheres to EMEA/FDA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines.
• Performs literature searches and reviews as necessary to obtain background information and provide literature references.
• Responsible for development of medical writing SOPs and style guidelines.
• Manages the timeline for the preparation of the documents, creating details processes, setting up kick off meetings and comment resolution meetings, owns workflows in Veeva
• Perform other duties as assigned

Role Requirements:

• Education: Bachelor’s degree or equivalent in a scientific discipline, advanced degree preferred
• At least 7 years’ experience in regulatory writing and knowledge of preparing documents to ICH standards.
• Prior experience within the Pharmaceutical or CRO industry
• Strong scientific and/or medical writing knowledge preferred
• Ability to lead writing and compilation of clinical documents
• Ability to influence and drive key decisions and stakeholders within a project team
• Strong understanding of pharmaceutical industry procedures and regulations
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.

Compensation & Benefits:

The expected salary range for this position is $114,000.00 - $150,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.