Sr Director, Global Regulatory Medical Writing & Data Transparency

About the position Responsibilities • Provide leadership and direction to a team of medical writers and electronic document specialists. • Ensure the production of high-quality clinical research documentation in compliance with regulatory guidelines. • Serve as a liaison among internal functional groups to optimize medical writing support for projects. • Mentor and develop manager-level direct reports in regulatory medical writing processes and standards. Requirements • PhD in life sciences or related field with a minimum of 10 years of experience in medical writing, or a Master's degree with a minimum of 15 years of experience. • Expertise in setting regulatory medical writing processes and technical standards. • In-depth knowledge of global regulations and guidelines for document submissions. • Proven experience in clinical drug development and regulatory medical writing. Nice-to-haves • Experience in a leadership role within a global function. • Strong communication and interpersonal skills to liaise with various stakeholders. Benefits • Comprehensive Health Insurance (Medical, Dental, Vision, and Prescription coverage). • 401(k) with employer match and annual Defined Contribution. • Paid Time Off including vacation, sick time, caretaker time, and paid holidays. • Company paid Life and Disability insurance. • Employee Assistance Program and Employee Stock Purchase Plan. • Tuition Assistance and Flexible Spending Accounts. • Paid Parental Leave and Family Building Benefits. • Virtual Physical Therapy and various insurance options. Apply tot his job Apply To this Job