Use Your Power for Purpose
Our mission is straightforward: empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.
What You Will Achieve
In this role, you will:
1. Provide guidance to medical writing vendors and project teams on standard processes for preparing safety narratives, plain language study results summary (PLSRS) documents, and associated deliverables within scope of Medical Writing. Guidance is based on understanding and knowledge of the underlying operational principles of applicable processes.
2. Be responsible to directly use and leverage artificial intelligence (AI)-enabled tools, automation platforms, and document generation systems in the process of developing medical writing documents. Includes ability to communicate to stakeholders as a subject matter expert in automation/AI tools; lead tool assessments to improve technical solutions, user acceptance testing, and implementation efforts; harness prompt generation and application; and other relevant activities.
3. Plan and manage projects to ensure that vendors complete deliverables within agreed-upon timelines, follow processes, and meet quality expectations. Identify, communicate, and resolve issues affecting project timelines, processes, and/or quality.
4. Manage routine vendor interactions, including preparation of work requests, procurement of access to internal systems, and monitoring of training compliance. Attend regular operational governance meetings with vendors. Assist management with forecasting by generating and/or reviewing reports from internal systems.
5. Assist Business Process Owners (BPOs) in maintenance of standard operating procedures (SOPs), work instructions (WIs), and templates and development of narrative and PLSRS training. Suggest or identify modifications and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity; develop innovative options to resolve complex problems and improve operational efficiency of business processes.
6. Support continuous process improvement by collecting and reviewing key performance indicator metric data from vendors to identify trends or issues. Lead workstreams in collaboration with management to develop and implement remediation plans.
Here Is What You Need:
7. At minimum bachelor’s degree or equivalent in medical-related field or life science. BS/BA or MS/MA with strong experience of medical writing or vendor management in the pharmaceutical or biotech industry.
8. Experience with overseeing multiple medical writing deliverables at various stages across multiple project teams and vendors. Ability to work independently, multi-task, and work effectively under pressure; adapt to change as needed; ability to analyze and solve complex problems; and possess excellent project management and issue resolution skills.
9. Proficient in application of automation and AI in the development of medical writing documents, including the ability to expertly use automation/AI tools; to identify and escalate technical issues; to lead change management by guiding stakeholders through the adoption of new technologies; and demonstrate responsible AI practices, including risk management and ethical use.
10. A comprehensive understanding of the drug development process, including knowledge of ICH and other regulatory guidelines, and ability to interpret and apply guidelines.
11. Demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; and escalate complex issues appropriately.
12. Extensive knowledge of vendor processes and best practices in outsourcing.
13. Exceptional written and verbal communication skills. High level of attention to detail and organizational skills.
14. Experience with software commonly used to present and analyze data, such as Word, PowerPoint, and Excel.
Work Location Assignment: Remote
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Medical