Medical Writer – Contractor

• Create documents for pre-marketing and post-marketing clinical trials, medical affairs, safety data, product development, license application, and post-marketing maintenance
• Analyze, review, and interpret non-clinical and clinical safety data and other relevant sources
• Author and review aggregate reports, including PSURs/PBRERs, PADERs/Annual Reports/ACO/DSUR
• Author and review Risk Management Plans
• Author and review Clinical Study Reports and Protocols
• Perform qualitative and quantitative signal assessment
• Perform literature searches and present relevant articles for aggregate reports
• Manage and reconcile relevant process trackers
• Serve as a subject matter expert and train and mentor individuals
• Generate Periodic Safety Line Listings (PSLL) from safety databases
• Handle regulatory agency and Pharmacovigilance Risk Assessment Committee (PRAC) inquiries
• Provide support for high-priority ad-hoc activities
• Ensure client deliverables comply with relevant regulatory requirements and meet agreed timelines
• Collaborate with Regulatory Affairs on reporting pharmacovigilance and drug safety information to regulatory agencies and prescriber communities
• Train and mentor Pharmacovigilance associates

• Minimum 2 years of experience in Medical Writing
• Degree in Life Science/Pharma or Equivalent
• Proficient computer knowledge and computer keyboarding skills
• Proficient with Microsoft Office Suite (Outlook, Word, Excel)
• Strong verbal, written and interpersonal communication skills
• Strong organization and prioritization skills; able to multitask
• Flexibility to adapt and meet fluctuating business priorities
• Able to occasionally work extended and/or flexible schedule to meet client requirements
• Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders
• Excellent verbal, written and presentation skills
• Innovative, collaborative, initiative-taker

• Hourly rate commensurate with Drug Safety medical writing experience level
• Contract, as-needed agreement to be extended in the form of a Scope of Work consulting document