At a Glance
- Tasks: Lead and oversee high-quality medical writing for clinical and regulatory documents.
- Company: Orion Pharma, a leader in oncology-focused drug development.
- Benefits: Competitive salary, professional growth opportunities, and a collaborative work environment.
- Other info: Join a dynamic team dedicated to scientific excellence and continuous improvement.
- Why this job: Make a significant impact in oncology by shaping clinical development strategies.
- Qualifications: Extensive experience in oncology drug development and strong leadership skills.
The predicted salary is between 80000 - 100000 £ per year.
Job Description Head of Medical Writing provides strategic, scientific, and operational leadership for the Medical Writing function and is accountable for delivering high‑quality clinical and regulatory documents across the entire development lifecycle, from First‑in‑Human studies through global registration and life‑cycle management activities.
The role combines functional leadership with direct program‑level contribution.
The incumbent serves as the Head of Medical Writing and primary author for one or more clinical development programs, while overseeing medical writing activities across all company‑sponsored studies and regulatory submissions.
The Head establishes and executes the global medical writing strategy, builds and leads internal and external medical writing capabilities, and ensures timely preparation of clear, scientifically robust, and regulatory‑compliant documentation in support of clinical development programs and global regulatory submissions.
Given the company’s oncology‑focused portfolio, the role requires extensive experience in oncology drug development and deep understanding of evolving regulatory expectations for innovative oncology therapies.
The Head also leads process optimization and continuous improvement efforts.
Main Responsibilities Functional Leadership Provide strategic leadership and oversight for the Medical Writing function.
Develop and implement the medical writing strategy to support clinical development, regulatory submissions, and corporate objectives.
Establish and maintain standards, processes, templates, and best practices to ensure consistency, efficiency, and quality across all medical writing activities.
Build, develop, mentor, and manage internal and external medical writing resources.
Lead resource planning, budgeting, and vendor oversight for medical writing activities.
Represent Medical Writing in operational planning, clinical development teams, and cross‑functional working groups, governance committees where applicable.
Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement.
Program Medical Writing
Head of Medical Writing, Global Clinical Operations, Orion Pharma employer: JobRx, Inc.
Orion Pharma is an exceptional employer that prioritises innovation and excellence in the field of oncology drug development. With a strong commitment to employee growth, we offer comprehensive training and mentorship opportunities, fostering a collaborative work culture that values scientific integrity and accountability. Located in a dynamic environment, our team enjoys the unique advantage of contributing to groundbreaking therapies while being supported by a robust framework for professional development.
