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.
- 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.
- Manages all aspects of document development process and leads project teams through process.
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.
- Analyzes, interprets, and distills data and other information to create documents.
- 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.
- Produces documents in conjunction with vendors as needed.
- 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.
- Independently authors complex documents that are compliant with relevant internal processes and standards as well as external regulatory guidance.
- 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.
- Develops and maintains project timelines.
- Drives decision making about data presentation strategies to support advance planning of documents.
- Understands the principles of scientific writing; writing with the audience in mind and conveying messages in a clear and concise manner.
- Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
- Aligns with department management to set strategy for meeting department goals.
- Is facile with innovative problem solving and peer influence.
- BS/BA +7 years, MS/MA +5 years, PhD +2 years of experience in medical writing or related field
- Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing.
- Ability to manage documents of greater complexity and/or variety.
- Ability to mentor more junior colleagues.
- Demonstrates knowledge of Pfizer business divisions and interrelationships between them.
- Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
- Ability to identify complex problems that require management or cross-functional input for resolution in timely manner.
- Ability to collaborate with cross-functional peers across therapeutic areas for improving a process, not limited to medical writing.
- Advanced degree (MS/MA/PhD) is preferred.
- Comprehensive understanding of medical concepts of the disease and current standard treatments.
- Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
- Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel).
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
- 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.
- Adapts to change as needed.
- Participates in discussions of benefit/risk assessment and regulatory impact of documents and analyses.
- Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones.
- Analytic skills.
- Oral presentation skills. Strong oral presentation skills, including ability to present and explain data analyses.
- Ability to examine data and formulate reasonable hypotheses.
- 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.
- Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data
- Language skills. High fluency in spoken and written English.
- Prior experience with document management systems and collaboration software (including cloud-based systems) and co-authoring principles is preferred.
- Contributes to improvements in templates, procedures, job aids, and onboarding and training materials for function.
- Understanding of the role of each member of cross-functional team.
- Comprehensive understanding of the drug development process and how medical writing documents support development at different stages.
- Develops innovative options to resolve complex problems that impact project completion.
- Able to interpret analyses of data supporting regulatory/clinical documents and to summarize in clearly written text with minimal guidance from team members.
- Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, with guidance.
- Bachelor’s degree, preferably in a life science discipline.
Vacancy Type: Full Time
Job Location: Toronto, Ontario, CA
Application Deadline: N/A