Scientific Writing Manager - BPD
Functions as a member of the Biopharmaceutical Development (BPD) Scientific Writing (SW) team and, independently with limited guidance, manages the preparation and review process of regulatory documents for the quality (CMC) modules for global submissions across early and late stage of biologics development. As a member of the SW team, coordinates and consults on regulatory filings, writing processes, and initiatives to advance the AstraZeneca pipeline and support marketed products.
Major Duties and Responsibilities:
Independently with limited guidance performs the following tasks:
Prepare and manage
- CMC sections for clinical trial applications (CTAs), investigator brochures, clinical study protocols
- CTA amendments
- Responses to questions from regulatory agencies
- Briefing books
May lead preparation of BLA/MAA sections with one or more BPD function
May lead template and procedure preparations including stakeholder management
Lead the process of critical review of development and regulatory documents and incorporating multiple internal and external reviews into quality documents
Manage submission preparation activities for multiple projects at different development stages
Coordinate and manage work streams within and across departments and across the company
Actively participate in project CMC teams and provide the interface between the team and the SW group
May have direct supervisory responsibilities over service providers and junior staff
Manage preparation and editing documents prepared by junior staff and service providers
Provides guidance to staff on regulatory submissions and development reports
Education: PhD, Master's or Bachelor's in a relevant technical discipline such as cell culture, purification, analytical biochemistry, formulation, device, drug delivery, etc.
Experience: PhD with 1+ years or Master's with 3+ years or Bachelor's with 5+ years of biopharmaceutical industry experience. Experience with electronic submission systems, editing and reviewing large documents is required. Technical writing experience is desirable, while experience preparing CMC regulatory documents and manuscripts is preferred. Experience working in a matrix environment is preferred. RAC or PMP certification is desirable.
- Background in biologics such as monoclonal antibodies and/or vaccines.
- Must have strong written and oral communication skills.
- Must have strong interpersonal skills.
- Must be able to work on multiple projects.
- Must be proficient in Microsoft Office.
- Knowledge and understanding of FDA regulatory requirements and ICH guidelines.
- Experience in working with Style Guides or Authoring Tools and electronic submission systems.
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 authorisation and employment eligibility verification requirements.