Principal Medical Writer – Nonclinical Focus

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

📋 Description

• Plan and prepare regulatory documents and medical communications independently to support all stages of product development.

• Organize, analyze, interpret, and present scientific and statistical data in accordance with ICH, regulatory guidelines, and company document standards.

• Collaborate with both internal and external document production teams under the direction of Medical Writing management.

• Lead internal project teams and foresee how writing conventions may impact health authority approval or acceptance.

• Develop and take ownership of submission-level documents and sections such as nonclinical Module 2.6.

• Create summary reports by integrating data from various sources and documents.

• Offer subject matter expertise for document preparation, review, comment resolution, incorporation, and finalization.

• Guide team members towards shared objectives within specified timelines and budgets for complex projects.

• Mentor others on the communication implications of decision-making.

• Build professional relationships with clients while staying updated on current industry knowledge.

• Identify and implement effective work practices to ensure consistent performance.

• Address challenges in sensitive or high-pressure scenarios.

• Integrate technical knowledge across various therapy areas and share expertise throughout the organization.

⛳️ Requirements

• A Bachelor’s degree is required; an MS or PhD is preferred.

• At least 7 years of regulatory writing experience or equivalent experience with nonclinical CTD sections.

• Familiarity with CTD sections 2.4 Nonclinical Overview and 2.6 Nonclinical Summaries.

• Experience with pharmacology, pharmacokinetic (ADME), or toxicology reports.

• Knowledge of regulatory authority guidelines and requirements.

• Proven experience in leading internal project teams.

• Experience in developing submission-level documents.

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

• Knowledge of document management techniques.

• Strong comprehension of document creation processes and the drug development lifecycle.

• Ability to synthesize data from multiple sources and documents.

• Expertise in preparing quality documents, document review, accurate comment resolution/incorporation, and document finalization.

• Capability to manage submission-level sections and lead complex projects within set timelines and budgets.

• Understanding of communication best practices.

• Experience in fostering professional client relationships.

• Extensive experience and technical knowledge across multiple therapy areas.

🏝️ Benefits

• Applicable bonus.

• Remote working opportunities.

• Flexible time off policies.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement programs.

• Retirement plans.