What you will do
Let s do this. Let s change the world. In this vital role you will the Project Management Coordinator will play a key role for the management of Research Documents controlled documents through helping to strengthen and advance Amgen s RD Quality Management System. This role contributes to implementing strategies and to ensure excellence in RD controlled document management.
Roles Responsibilities:
As an integral team member working globally with RD Quality team members and RD Business Process Owners to ensure compliance with GCP regulations and other requirements:
- Provide technical writing and editing expertise to support the generation of robust, well-written RD controlled documents.
- Coordinate workflows for RD documents (e. g. , SOPs) in controlled document management system.
- Oversee workflow completion, updates, tracking status, and follow-up activities.
- Perform Quality Checks and editing against RD templates.
- Assist PM/Quality Lead with writing support during project meetings.
- Follow step-by-step instructions and perform repetitive tasks accurately
- Communicate and educate clients on RD document processes, troubleshooting issues, and resolving complaints
- Supports Amgen s procedural framework so that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity.
- Coordinate workflows for RD documents (e. g. , SOPs) in controlled document management system
- Ensures that all procedures are written clearly for the execution of Amgen s GCP/GPvP/GLP research regulations within a diverse, complex, and cross-functional team of researchers.
- Supports the change control of business procedures in a timely manner with a focus on detail and the output of concisely written documentation.
- Supports incoming procedural change requests, including the assessment of changes (impact to the QMS, including traceability of changes across other document sets.
- Applies industry standard methodologies for optimal (standardized and lean) procedural documentation, and the use of technology to drive an efficient and effective GCP/GPvP/GLP quality management system
What we expect of you
Basic Qualifications and Experience:
- Master s degree and 1-3 years in Pharma and Biotechnology RD Quality OR
- Bachelor s degree and 3-5 years in Pharma and Biotechnology RD Quality.
- Diploma degree and 7-9 years in Pharma and Biotechnology RD Quality.
Functional Skills:
Must-Have Skills:
- Exceptional attention to detail and accuracy in all deliverables.
- Ability to work independently and proactively in a fast-paced environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e. g. , Teams, WebEx)
- Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse RD environment.
- Complex document management in the RD space with experience in GCP regulations.
- Effective communication, critical thinking and problem-solving
Good-to-Have Skills:
- Familiarity with project management tools and methodologies.
- Knowledge of GCP, GLP and/or GPvP.
- Experience working in a multinational environment with global teams.
- Experience within Biotech/pharmaceutical Research, including the application of Global Regulations.
- Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes.
- Independent and team work capabilities
- Operational and compliance-critical administrative support
Soft Skills:
- Excellent verbal and written communication skills.
- High degree of professionalism and interpersonal skills.
- Strong problem-solving abilities and adaptability to changing priorities.
- Collaborative attitude and ability to build positive relationships across diverse teams.
- Resilience, discretion, and the ability to thrive under pressure
Equal opportunity statement
- Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
- We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
What you can expect of us
- As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.
- In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
