Job Location: Chicago, IL

Regular FT Opportunity

Job Summary

The successful candidate will be a senior member of the Medical Writing team in the Global Pharmaceutical organization. The Medical Writer is responsible for the timely analysis of safety data for marketed products and summarization of the data in aggregate safety reports for submission to regulatory agencies around the world. The Medical Writer is also a team leader providing guidance in safety writing procedures and training.

Job Responsibilities

• Supervise safety writing projects for the Global Pharmaceutical  organization
• Assist in the management of safety writing report timelines, resources, and project workload
• Assist in the training of other safety writing team members, providing functional expertise and guidance
• Assist with creation and maintenance of standardized departmental procedures for safety writing and processing safety regulatory documents for submission (e.g., PSURs, PADERs) and other safety reports as required. MUST HAVE THE PADER exp.
• Write and prepare safety regulatory documents and submissions, including complex stand-alone documents and submissions
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
• Ensure data issues are addressed and resolved prior to document sign-off
• Assist in the facilitation of document review meetings and discussions
• Collaborate with regional country organizations in processing safety regulatory submission documents
• Oversee safety writing projects for designated therapeutic areas
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas
• Participate in surveillance activities with medical reviewers as applicable to safety writing activities
• Participate in risk management activities as applicable to safety writing activities
• Collaborate with safety and medical reviewers on safety-related issues relative to safety writing activities
• Interface with other groups as needed (e.g., Regulatory Affairs, Quality, Information Technology, business units)
• Collaborate with groups to compile safety data for presentation at internal, external and professional meetings
• Assist in the management of safety writing project teams as assigned
• Participate on project teams and committees as assigned
• Additional responsibilities and projects as assigned

Job Requirements

• Bachelor’s degree in a medical / science / nursing field or comparable experience; advanced degree preferred
• Previous pharmaceutical industry experience in medical / safety writing (minimum four (4) years)
• Previous experience working in Pharmaceutical  or clinical development
• Exposure to a working relationship with FDA and other regulatory authorities
• Demonstrated leadership in a team environment
• Experience preparing postmarketing safety regulatory documents (e.g., PSURs and related documents, PADERs, assessor report responses)
• Knowledge of safety reporting regulations (pre- and postmarketing)
• Experience with coding dictionaries (e.g., MedDRA)
• Excellent scientific writing skills
• Scientific / medical knowledge
• Excellent verbal and written communication skills
• Excellent analytical and problem-solving skills
• Excellent interpersonal skills
• Proficiency working in Microsoft Office applications and medical / scientific publication databases / resources
• Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus