JOB SUMMARY
- 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.
JOB RESPONSIBILITIES
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.
- Engage with colleagues to understand and document business processes and capture requirements.
- Possess an interest and ability to learn about new approaches and technologies.
Content Management & Authoring
- Provide expert level guidance on the use of generative AI, structured content authoring, and content management solutions
- Development of LLM prompts to support the development of document automation workflows
- Implementation of authoring technologies
- Provide real time support to authoring stakeholders across a broad variety of business areas
- Serve as SME for Submission-Ready (SR) initiatives, and submission formatting requirements.
- Support colleagues on use of SR templates, acts as SME for SR formatting, and supports all documentation needs during regulatory filings.
- including managing timelines for all assigned deliverables and ensuring that all documents assigned meet expected key milestone timelines and document publishing standards.
- Serve as technical subject matter expert for coauthoring platform including: Manage study team system access and permissions. Provide technical support to study team members in authoring role. Prepare document for study team collaborative review(s). Manage systems’ workflows such as governance reviews, and quality reviews.
- Create and maintain templates including but not limited to Clinical Study Protocols, Clinical Study Reports, Clinical Summary Documents.
- Create and maintain digital libraries for references
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- Bachelor’s degree in computer science, Information Systems, statistics, biostatistics, mathematics, or life sciences or related field.
- Proven/extensive relevant experience
- Have an understanding of clinical data & it’s structure (e.g. CDISC standards)
- Excellent analytical and problem-solving skills.
- Ability to communicate effectively with technical and non-technical stakeholders.
- Strong attention to detail and ability to manage multiple priorities effectively.
- Vendor and resource management experience
Preferred Requirements:
- 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.
QUALIFICATIONS / SKILLS
- Bachelor’s degree, preferably in a life science discipline.
- Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
- Ability to manage documents of simple complexity and/or limited variety.
- 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.
- Adapts to change as needed.
- Chooses between multiple options to resolve moderately complex problems that impact project completion.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
- Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing.
- Basic understanding of the drug development process.
- 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).
ORGANIZATIONAL RELATIONSHIPS
Clinical, Clinical Operations, Clinical Pharmacology, Clinical Trial Disclosure, Portfolio & Project Management, Regulatory, Safety, Statistical Programming & Analysis
The closing deadline for applications is October 27th.
All applicants must have the relevant authorisation to live and work in the UK or Greece as applicable.
Work Location Assignment: On Premise (flexible working policy applies). |
ORGANIZATIONAL RELATIONSHIPS
Clinical, Clinical Operations, Clinical Pharmacology, Clinical Trial Disclosure, Portfolio & Project Management, Regulatory, Safety, Statistical Programming & Analysis
The closing deadline for applications is October 27th.
All applicants must have the relevant authorisation to live and work in the UK or Greece as applicable.
Work Location Assignment: On Premise (flexible working policy applies). |
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