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

Within Clinical Regulatory Writing, we provide expert communications leadership to drug projects and author strategically important clinical-regulatory documents that 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 strategic communication excellence to achieve successful submissions and approvals.

We are currently looking for a Clinical Regulatory Writing Operations Manager to join our team.

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

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 submits 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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.