Job Title

• Medical Writer III - PSUR
  

Position Description

• The Medical Writer III is responsible for the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update reports (PSURs), and other ad hoc safety documents for submission to regulatory agencies around the world. The Medical Writer III is also a team leader providing guidance in safety writing procedures and training.
  

Position Responsibilities

• Assist in the management of safety writing report timelines, resources, and project workload
• Assist in the training of safety writing team members, providing functional expertise and guidance 
• Write and prepare standalone postmarketing aggregate safety documents for regulatory submission, such as PSURs and associated documents, and PADERs 
• 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
• Facilitate document review by other contributors
• Assist with the creation and maintenance of standardized departmental procedures concerning the writing of Safety reports and processing of the reports for regulatory submission
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas 
• Collaborate with medical reviewers, epidemiology, and risk management concerning safety issues relative to safety writing activities
• Interface with other functional groups such as Regulatory Affairs, Quality, Information Technology, business units, as needed 
• Lead or participate in project teams and committees as assigned 
• Act as therapeutic area team leader
• Demonstrated leadership in a team environment
• Experience preparing postmarketing safety regulatory documents such as PSURs and associated documents, and PADERs
• Knowledge of global postmarketing safety reporting regulations and guidances 
• Experience with coding dictionaries such as MedDRA
• Excellent scientific writing skills
   
  

Position Requirements

• Bachelor’s degree in a medical / scientific field plus at least four (4) years pharmacovigilance experience, or a Master’s degree plus at least two (2) years pharmacovigilance experience
• Previous experience writing PADERs and/or PSURs 
• Exposure to a working relationship with FDA and other regulatory authoritiesmeeting expectations of regulatory authorities for aggregate safety reports
• Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus
• Proficiency for the following competencies are key to success in the Risk Management Group.
• Scientific and Technical Analysis – 
• Provide Guidance to internal project teams in the area of design and analysis for more complex or high risk projects
• Submission Project Mgmt – Provide direction and guidance to more junior staff in response to complex AE reporting and content, documents, timeline
• Product/Process Quality Standards - Oversee the education of internal stakeholders on implications of regulations
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance