Manager, Clinical Regulatory Writing

Job Title: Manager, Clinical Regulatory Writing

Career Level: D

Introduction to role

Role holders provide communications expertise by leading teams in the delivery of high-quality clinical regulatory documents. They work primarily at the document development level with occasional contributions to communication strategy development at a program level. They contribute to improvement projects.

Accountabilities

The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company’s core therapeutic areas in all phases of clinical development. Our vision is to be an industry-leading organization driving essential communication excellence to achieve successful submissions and approvals. The Clinical Regulatory Writing Manager is expected to:

• With limited guidance, lead author and ensure the timely delivery of high-quality clinical-regulatory documents.
• Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and standard methodology are applied.
• Have the ability to balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.
• Drive the clinical interpretation of data and information and condense it into clear, concise and accurate messages that address customer information requirements.
• Provide critical review of documents for correctness, clarity, completeness and compliance.
• Proactively collaborate with other functions during document development, including, as needed, with external service providers/contractors.
• As part of a clinical delivery team, provide communications support to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
• Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Clinical Regulatory Writing on drug and non-drug projects, as required.
• Work independently but with the guidance and support of more senior members of the group.

Essential Skills/Experience

• Life Sciences degree in an appropriate subject area.
• Experience in medical communications.
• Strong communication and leadership skills.
• Knowledge of the technical and regulatory requirements related to the role.

Desirable Skills/Experience

• Advanced degree in a scientific discipline (Ph.D).
• Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

A dedicated Oncology unit, this is the place to build a world-class career. Here we are always looking to learn more, welcoming the varied opportunities to expand our horizons or develop niche expertise. Embrace the unparalleled access to industry-leading research, technology and pipeline product launches with a footprint in every region. Coupled with our agility and sharp focus on talent development, there is an exciting opportunity to accelerate a rewarding and meaningful career.

Ready to make a difference? Apply now!