Director, Patient Safety Medical Writing

Director, Patient Safety Medical Writing

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart(R).

About the Role

We are seeking a Director, Patient Safety Medical Writing to join our team. As a Director, Patient Safety Medical Writing, you will provide operational leadership for your assigned area within the Patient Safety department, ensuring quality and compliance across operations, medical writing, project management, or quality pillars. This position plays a key role in managing team development, quality initiatives, compliance activities, and process improvements while collaborating across teams to maintain and enhance Patient Safety standards. You'll serve as a functional representative, implementing the vision and values of Parexel's Patient Safety organization.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic oversight of patient safety operations, driving quality excellence, and fostering a culture of continuous improvement. With diverse teams and continuous learning opportunities, the Director, Patient Safety Medical Writing can explore career paths and expand skills across clinical research and organizational leadership.

Key Responsibilities

• Lead and manage your assigned team and function within the respective Patient Safety pillar, including recruitment, performance management, career development, and succession planning

• Implement pillar-specific strategies aligned with Parexel's global Patient Safety objectives and contribute to operational plans, budget management, and resource allocation

• Maintain compliance with all applicable global and local regulations (ICH, CIOMS, GVP, and multi-region pharmacovigilance requirements) and implement Patient Safety Quality initiatives

• Develop, review, and oversee SOPs, metrics, and quality oversight systems including KPIs, audits, and CAPA processes to ensure safety data quality and document integrity

• Manage projects and client relationships, ensuring delivery on expected standards of productivity, quality, compliance, and revenue while overseeing efficient budgeting and financial monitoring

• Drive workflow enhancement projects and process excellence initiatives that streamline operations, accelerate delivery cycles, and leverage automation and AI to enhance safety workflow efficiency

• Lead cross-functional teams in the deployment and optimization of pharmacovigilance systems and digital solutions, establishing performance metrics to measure effectiveness and drive data-informed decisions

• Represent Patient Safety in functional forums, projects, and selected external interactions while supporting collaboration across Patient Safety pillars to ensure integrated, high-quality delivery

• Coach staff in Patient Safety best practices and quality standards, supporting ongoing professional education and participation in regulatory meetings, industry forums, and scientific conferences

You'll thrive in this role if you bring:

• Strong knowledge of clinical, scientific, and regulatory aspects of drug safety and patient safety

• Demonstrated ability in managing teams and supporting quality and compliance initiatives

• Effective operational and tactical skills including planning, budgeting, and influencing

• Strong communication, negotiation, and stakeholder management skills

• A patient-focused mindset and strong attention to detail

Required Qualifications

• Bachelor's degree or equivalent experience in health sciences or a related discipline

• Significant experience in pharmacovigilance, drug safety, medical writing, safety operations, project management, or quality management

• Proven experience as a team leader within Patient Safety or related fields

• Experience in project and client management, including support of audits and inspections

• Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes

• Strong communication, organization, and problem-solving skills

Preferred Qualifications

• Advanced degree in health sciences, clinical research, or a related discipline

• Experience with pharmacovigilance systems, CTMS, eTMF, or other clinical research technology platforms

• Familiarity with AI and automation initiatives in clinical research or safety operations

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be perfect fit, send them the link to apply!

Experience Level

Executive Level