Operations Manager (Document Quality Control [QC] and Literature References) – Clinical Regulatory Writing

Job Title: Operations Manager (Document Quality Control [QC] and Literature References) – Clinical Regulatory Writing

Career Level - D

The Clinical Regulatory Writing Operations Manager manages multiple operational aspects of the Clinical Regulatory Writing (CReW) group and is responsible for overseeing and managing planning, compliance, cross-functional collaborations, vendor management, and clinical-regulatory document quality control (QC) and documentation requirements.

The Operations Manager (Document QC and Literature References) supports two distinct activities: Clinical-regulatory document QC and literature references. The Operations Manager performs data, content, and style/formatting QC on clinical-regulatory documents, manages outsourcing of QC projects to vendors, and complies with QC documentation requirements. Additionally, the Operations Manager orders literature references documents with appropriate copyright permissions, ensures the documents meet standard publishing requirements, and submit the documents for publishing in the electronic data management system. The Operations Manager must complete the clinical-regulatory document QC and literature references projects within the required timelines, often with competing timelines. The position belongs to the CReW Business Planning, Operations and Vendor Management (CReW BOV) team.

Responsibilities include:

• Perform expedited business-critical QC requests
• Being able to QC documents according to AZ QC documentation requirements
• Project management of outsourced QC requests
• Handle literature references process (collection, copyright, and publishing)
• Collaborate cross-functionally and contribute to continuous improvement within CReW and across the organization

Essential for the role:

• High School Diploma (or equivalent) required
• Knowledge of structure of clinical regulatory documents and sources to author documents
• Excellent communication skills
• Attention to detail
• Good organization, project management and administration skills
• Ability to work to deadlines
• Problem-solving skills
• Proficiency in Microsoft Office
• Proficiency in English

Desirable for the role:

• Team player
• Experience of technology and systems (e.g. MS SharePoint skills)
• Experience of developing and delivering training material

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.

At AstraZeneca, we are pioneers in Oncology R&D, pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.

Ready to join us in our mission to eliminate cancer as a cause of death? Apply now!