Principal Medical Writer - Remote

About the position The Principal Medical Writer at Takeda Pharmaceuticals plays a crucial role in the research and development organization by formulating writing strategies for key clinical and regulatory documents. This position involves guiding the preparation of documents for regulatory submissions, coordinating with internal and external writers, and ensuring compliance with regulatory requirements. The role requires expertise in medical writing and the ability to work independently while collaborating with cross-functional teams to deliver high-quality submissions. Responsibilities • Guide medical writing activities for key clinical and regulatory documents and regulatory submissions. • Lead the writing strategy providing expertise including organization, content, timelines, and resource requirements. • Provide advanced input for study designs, analysis plans, sections of INDs and marketing applications. • Coordinate activities of Takeda, contract employees, and vendors, ensuring resolution of issues. • Manage deliverables and preparation of documents for submission to FDA or other regulatory agencies. • Represent Medical Writing on cross-functional teams and task forces. • Serve as lead writer for important clinical and regulatory documents and key components of regulatory submissions. • Provide leadership on functional teams addressing requirements or issues related to document preparation. Requirements • Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor's degree is required. • At least 7 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required. • Experience as lead writer for key documents included in major US and/or international regulatory submissions required. • Clear understanding of clinical development phases, processes, and techniques used within a clinical development environment. • Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation. • Well-developed oral and written communication skills; ability to clearly present technical information. • Demonstrated problem-solving and interpersonal skills that facilitate effective interactions. Nice-to-haves • Experience managing writing activities for a major US or international regulatory submission preferred. • Knowledge of team dynamics and ability to function as a team leader. Benefits • Medical, dental, vision insurance • 401(k) plan and company match • Short-term and long-term disability coverage • Basic life insurance • Tuition reimbursement program • Paid volunteer time off • Company holidays • Well-being benefits • Sick time and paid vacation accrual. Apply tot his job

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