Senior Medical Writer
- Experience Level
- Experienced (non-manager)
We are experiencing exponential growth on a global scale in our Project-Based Services (PBS) team. You will support Phase I –IV clinical studies across a variety of therapeutic areas. If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with our team of High Achievers!
Summary of Job Responsibilities:
- Act as a functional lead for medical writing projects, and coordinating within and across departments.
- Manage all medical writing activities associated with individual projects and work independently on complex projects.
- Develops or supports a variety of documents including protocols, clinical study reports, patient narratives, IND submissions, integrated summary reports, annual reports, investigator brochures, clinical development plans, NDA and (e)CTD submissions, manuscripts, abstracts, client presentations. etc.
- Performs peer review / quality control (QC) of clinical study reports and other submissions written by other medical writers.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Identifies issues, and proposes solutions to resolve them during the writing process. Where required, escalate issues, as appropriate.
- Liaise with other functional groups (e.g. data management, statistical programming, biostatistics, project management, and publishing vendors) to ensure timely delivery and quality of writing deliverables.
- Keeps management informed on progress of documents and other project related activities, assist management in projecting efforts, and perform administrative duties as requested.
- Performs on-line clinical literature searches, as applicable.
- Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
- Formulates writing strategy for key documents, including organization, content, timelines, and resource requirements; ensures that needs (e.g. headcount, funding, time) are appropriately represented to relevant teams and management.
- Prepares documents for submission to FDA or other regulatory agencies, ensuring consistency of content within the assigned submission or project and adherence to regulatory requirements and Cytel requirements and processes.
Qualifications and Experience:
Minimum Education: Bachelor’s/Master’s degree in a Life Science or Medical science related discipline. Advanced degree (Master's, PhD, MD, or local equivalent) a strong plus.
Minimum Work Requirements: Minimum of 5 years of pharmaceuticals, biotech, or CRO medical writing experience.
- Working knowledge of drug development process, ICH and other regulatory guidelines.
- Broad knowledge of global pharmaceutical regulatory requirements, and experience in clinical research or other areas of the pharmaceutical industry.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet. and keen attention to detail also are required.
- Must have excellent verbal/written communication skills and excellent presentation skills
- Documents are to be completed within a period that supports project needs and deadlines.
- Experience in a medical content generation is preferred
- Excellent interpersonal and conflict resolution skills
- Ability to demonstrate a familiarity with principles of clinical research, and to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
Prefer this experience in a CRO environment and/or Pharmaceutical Company
- Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
- In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
- Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.