Director, Patient Safety Medical Writing

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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 22000 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. Youll serve as a functional representative implementing the vision and values of Parexels Patient Safety organization.

Youll 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 Parexels 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

Youll 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

• Bachelors 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 doesnt sound like the next step in your career but perhaps you know of someone whod be perfect fit send them the link to apply!