Baxter International Inc.

Deerfield, IL, 60015, USA

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 requirementsEnsure data issues are addressed and resolved prior to document sign-offFacilitate document review by other contributorsAssist with the creation and maintenance of standardized departmental procedures concerning the writing of safety reports and processing of the reports for regulatory submissionParticipate 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 activitiesInterface 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 membersExperience preparing postmarketing safety regulatory documents including PSURs and associated documents, and PADERsKnowledge of global postmarketing safety reporting regulations and guidances Experience with coding dictionaries such as MedDRAExcellent scientific writing skillsScientific / medical knowledgeExcellent verbal and written communication skillsExcellent analytical and problem-solving skillsExcellent interpersonal skillsProficiency working in Microsoft Office applications and medical / scientific publication databases / resourcesBachelor?s degree in a medical / scientific field plus at least two (2) years pharmaceutical industry experience Exper

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