ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
Position Purpose: The Senior Medical Writer (Sr MW) will support regulatory filings and authoring of other regulatory documents (Late Stage).
- Reports to ExecuPharm (EP) Line Management with day-to-day direction from Client
- Liaises with cross-functional lines/vendors as appropriate
- With minimal guidance from senior members of writing staff, prepares clinical study reports, protocols, investigator brochures submission data summaries and other regulatory documents on investigational drugs in various stages of clinical development
- Circulates documents for team review and quality control/quality assurance and for addressing the reviewers’/auditors’ comments under aggressive timelines.
- Active member of cross-functional teams
- Conducts appropriate literature searches
- Pursues relevant training opportunities and additional project assignments with the goal of assuming increasing autonomy in the execution of responsibilities
- Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
- Adheres to EP and Client SOPs and processes
Skills and Education:
- B.A./B.S. preferred
- 5-8 years experience in regulatory filing and authoring clinical documents/summarizing clinical study results, including Clinical Study reports (CSRs), submission data summaries and other regulatory documents
- Oncology and/or Infectious Disease/Vaccines experience highly desired.
- Strong analytical skills
- Ability to organize large amounts of clinical data and make data driven decisions
- Demonstrated leadership skills with ability to work in cross-functional teams, multitask and perform under aggressive timelines
- Must be able to effectively collaborate with internal/external individuals and effectively manage resolution of scientific issues
- Must have understanding of clinical research process from program planning to submission, including clinical trial design
- Must have excellent oral (including presentation) and written communication, project management and computer/database management skills
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination or have an approved religious or medical exemption.