- The Medical Writer (Senior Manager/Associate Director) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
- Understands the principles of scientific writing; writing with the audience in mind and conveying messages in a clear and concise manner.
- Analyzes, interprets, and distills data and other information to create documents.
- Applies advanced knowledge of relevant regulatory requirements and corporate policies as well as work experience to assess document requirements and identify information gaps or other potential issues. Takes appropriate risks to resolve any identified issues.
- Is facile with innovative problem solving and peer influence.
- Independently authors complex documents that are compliant with relevant internal processes and standards as well as external regulatory guidance.
- Manages all aspects of document development process and leads project teams through process.
- Collaborates with project teams, subject matter experts, and quality lines to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Drives decision making about data presentation strategies to support advance planning of documents.
- Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
- Develops and maintains project timelines.
- Delivers assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality.
- Communicates Medical Writing’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
- Aligns with department management to set strategy for meeting department goals.
- Identifies potential areas for process improvements and possible solutions and communicates these to line management or appropriate functional line.
- If assigned by manager, serves as the Medical Writing ‘point of contact’ for all document issues for a given asset or set of assets.
- Produces documents in conjunction with vendors as needed.
- Bachelor’s degree, preferably in a life science discipline.
- BS/BA +7 years, MS/MA +5 years, PhD +2 years of experience in medical writing or related field
- Understanding of the role of each member of cross-functional team.
- Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
- Ability to manage documents of greater complexity and/or variety.
- Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
- Adapts to change as needed.
- Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones.
- Ability to identify complex problems that require management or cross-functional input for resolution in timely manner.
- Develops innovative options to resolve complex problems that impact project completion.
- Ability to mentor more junior colleagues.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
- Ability to collaborate with cross-functional peers across therapeutic areas for improving a process, not limited to medical writing.
- Extensive knowledge of the Pfizer Global Style Guide and all relevant SOPs (associated forms and work instructions) and process training that relate to medical writing deliverables and quality review of deliverables.
- Contributes to improvements in templates, procedures, job aids, and onboarding and training materials for function.
- Demonstrates knowledge of Pfizer business divisions and interrelationships between them.
- Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing.
- Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data
- Comprehensive understanding of the drug development process and how medical writing documents support development at different stages.
- Comprehensive understanding of medical concepts of the disease and current standard treatments.
- Analytic skills.
- Ability to examine data and formulate reasonable hypotheses.
- Oral presentation skills. Strong oral presentation skills, including ability to present and explain data analyses.
- Language skills. High fluency in spoken and written English.
- Knowledge of how to use publicly available databases (eg, PubMed, DailyMed, FDA and EMA sources and guidelines) for literature and informatio,n mining to support document content and how to cite such information appropriately.
- Able to interpret analyses of data supporting regulatory/clinical documents and to summarize in clearly written text with minimal guidance from team members.
- Participates in discussions of benefit/risk assessment and regulatory impact of documents and analyses.
- Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, with guidance.
- Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel).
- Advanced degree (MS/MA/PhD) is preferred.
- Prior experience with document management systems and collaboration software (including cloud-based systems) and co-authoring principles is preferred.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Some travel (~5%) across GPD sites for face to face meetings, if necessary.
- Depending on location may need to accommodate global teleconference calls across different time zones.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.