Principal Medical Writer - Remote

About the position 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 Apply To this Job