English Language Manager
5 days ago
Pfizer Research and Development(PRD) supports clinical development across Pfizer Every year, PRD partners with thousands of global participants, health systems and HCPs in our work to bring new medicines to market for the patients that we serve.
In coordination with PRD and COE colleagues, provide consultative services (business solutions), project management - execution and delivery (e.g., project schedule, resources, budget, issues, and risks etc.), change management, and communication for PRD stakeholders.
This role will partner with Pfizer Global Product Development, Worldwide Research & Development, Digital and other support functions to ensure timely project execution and delivery.
The team is seeking candidates that have a proven track record of performing analytical activities, but also possess a passion for developing creative solutions to meet changing clinical development needs.
Strategy & Implementation
Provide consultative services (business solutions), project management - execution and delivery (e.g., project schedule, resources, budget, issues, and risks etc.), change management, and communication for PRD stakeholders.
Lead a variety of operational activities including, but not limited to, writing meeting agendas, capturing meeting minutes, facilitating meetings.
Content Management & Authoring
Provide expert level guidance on the use of generative AI, structured content authoring, and content management solutions
Implementation of authoring technologies
Support colleagues on use of SR templates, acts as SME for SR formatting, and supports all documentation needs during regulatory filings.
Manage systems workflows such as governance reviews, and quality reviews.
Create and maintain digital libraries for references
Bachelors degree in computer science, Information Systems, statistics, biostatistics, mathematics, or life sciences or related field.
Have an understanding of clinical data & its structure (e.g. Vendor and resource management experience
Knowledge of drug development process, clinical trial methodology, statistics, and pharmaceutical submission documents (such as regulatory, clinical and CMC docs)
Experience with content management systems, structured content authoring, and or working with Large Language Models, LLMs
Experience creating/consuming SDTM and ADaM data sets, Tables, Figures and Listings
Strong project management skills including the ability to define the project scope, establish a timeline, coordinate resources, communicate status, and manage the delivery of results.
Bachelors degree, preferably in a life science discipline.
Ability to lead medium technical and process implementation efforts
Experience or demonstrated willingness to learn usage patterns, implementation methodologies and development of prompts using LLM technologies
Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
Chooses between multiple options to resolve moderately complex problems that impact project completion.
shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing.
Basic understanding of medical concepts of the disease and approaches to current standard treatments.
Language skills. High fluency in spoken and written English.
Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel, Sharepoint, TEAMS).
Clinical, Clinical Operations, Clinical Pharmacology, Clinical Trial Disclosure, Portfolio & Project Management, Regulatory, Safety, Statistical Programming & Analysis
Work Location Assignment: On Premise (flexible working policy applies).
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