- 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.
- JOB RESPONSIBILITIES
- 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
- BASIC QUALIFICATIONS
- 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.
- Contributes to improvements in templates, procedures, job aids, and onboarding and training materials for function.
- 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 information 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).
- PREFERRED QUALIFICATIONS
- 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.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.PHYSICAL/MENTAL REQUIREMENTS
NoneNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work Location Assignment: Remote
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. 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.