Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.The successful candidate will be a member of the Medical Writing team in the Global Pharmacovigilance organization. The Medical Writer II 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.
Responsibilities include, but are not limited to:
- 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 Baxter functional groups such as Regulatory Affairs, Quality, Information Technology, business units, as needed
- Lead or participate in project teams and committees as assigned
- Assist in the training of new safety writing team members
- Experience preparing postmarketing safety regulatory documents including 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
- 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
- Bachelor?s degree in a medical / scientific field plus at least two (2) years pharmaceutical industry experience
- Experience in pharmacovigilance, preferably writing PADERs and/or PSURs
- Exposure to meeting 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 ? Review analysis to validate the conclusions of safety studies and reports
Submission Project Mgmt ? Oversee the preparation, planning, coordination, execution, confirmation and ongoing maintenance of Adverse Event Reports
Product/Process Quality Standards ? Understand standards and communicate implications internally
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
