The primary responsibilities may include, but are not limited to the following:
Management of R&D process documentation per required process (e.g. Standard Operating Procedure [SOP] on SOPs) in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
Development and facilitation of the creation and/or revision of materials such as SOPs, manuals, and related business process documentation in conjunction with Subject Matter Experts. Note: these activities will usually take place virtually and across different time zones.
Liaison with other members of the QCA group (e.g. Business Process Modelers) and also the business (e.g. Business Process Owner, Document Owner, Authors, Subject Matter Experts).
Management of documents via the established R&D Document Review process using the electronic document repository (Vault Quality).
Track and provide regular updates to process project inventory tool and to key Points of Contact
Working with limited supervision, the successful candidate will be responsible for developing high quality, scientifically rigorous resources that adhere to internal guidelines, SOPs, policies and industry regulations within the oncology therapeutic area.
This will include, but not limited to:
Reviewing field-based promotional and educational materials for scientific accuracy as part of the Material Approval and Compliance (MAC)
Responding to escalations from the US call center to help address external customer questions regarding Amgen products and pipeline molecules
Developing de novo US Medical Content to be used in regional medical communications and/or regionalizing global GCC resources for Medical Information and Regional Medical Liaisons
Executing regional congress deliverables, disease state education programs and developing/adapting scientific content for online resources (e.g. websites, microsites, virtual congresses)
This role requires the ability to collaborate in a dynamic environment with multiple global and regional cross-functional teams, as well as to manage external providers and project-associated budgets.
Master’s degree and 3 years of clinical, academic, or industry experience
Bachelor’s degree and 5 years of clinical, academic, or industry experience
Associate’s degree and 10 years of clinical, academic, or industry experience
High school diploma / GED and 12 years of clinical, academic, or industry experience
Doctorate degree (PharmD, PhD, MD, DO) with one or more years of cumulative experience in Medical/Scientific Affairs, Clinical Development, Clinical Research, patient care, and/or basic research.
Prior experience in Medical Affairs or Clinical Development within the biopharmaceutical industry (or clinical experience) in the Hematology/Oncology disease area
Understanding of Scientific Communications projects including disease state education programs, advisory boards, congress/publication plans, and RML resources
Understanding of Medical Information capabilities, literature surveillance, adverse event and product complaints requirements
Experience with marketed products and late-stage pipeline products
Excellent written, oral, and presentation skills and the ability to critically analyze the scientific literature to form logical opinions and communicate key business and clinical information at multiple levels
An understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products
The ability to work in teams and interface in a dynamic environment across corporate functions
Prior experience managing consultants and vendors is desired.
"This posting is for Contingent Worker, not an FTE"