System One Medical Writer (Senior Manager/Associate Director) in New York, New York
REMOTE SR. MEDICAL WRITER
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.
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.
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.
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.
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.
• Biostatistics, Clinical, Clinical Operations, Clinical Pharmacology, Clinical Trial Disclosure Data Management &
Monitoring, Portfolio & Project Management, Regulatory, Safety, Statistical Programming & Analysis
• COVID-19 Trial (preferred)
• Therapeutic-Antiviral Experience
• Extensive Module 2 (2.5, 2.7.3, 2.7.4)
• Anti-Infective (preferred)
• Emergency use authorization (preferred)
• All hands on Deck
• Ability to attend meetings, calls on an as need basis
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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