Project Management Coordinator–documentation Management

Career Category Operations Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our focus on four therapeutic areas -Oncology Inflammation General Medicine and Rare Disease- we reach millions of patients each year As a member of the Amgen team you ll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives Our award-winning culture is collaborative innovative and science based If you have a passion for challenges and the opportunities that lay within them you ll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career Project Management Coordinator-Documentation Management 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 R D Quality Management System This role contributes to implementing strategies and to ensure excellence in R D controlled document management Roles Responsibilities As an integral team member working globally with R D Quality team members and R D 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 R D controlled documents Coordinate workflows for R D 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 R D 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 R D 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 R D 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 R D Quality OR Bachelor s degree and 3-5 years in Pharma and Biotechnology R D Quality Diploma degree and 7-9 years in Pharma and Biotechnology R D 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 R D environment Complex document management in the R D 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 Apply now and make a lasting impact with the Amgen team careers amgen com As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients Together we compete in the fight against serious disease Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law We will ensure that individuals with disabilities are provided 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 accommodation