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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We're looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
The SPO Specialist will provide clinical expertise across the acute therapy portfolio via development and review of various documents describing the clinical use of the products and benefit and risk of the products. As a healthcare company Baxter is required to develop and submit various regulatory and safety document to regulators around the works. This position will create and/or review various documents such as annual reports for acute therapy products, risk management plans, and changes to documents related to manufacturing and design changes. This person will work with cross functional teams globally: including individuals within Clinical Operations, HEOR, Medical, Quality, Regulatory and Patient Safety departments.
Essential Duties and Responsibilities
Provide medical/clinical expertise related to acute therapies and related products including their clinical use and potential misuse to internal cross function teams
Prepare clinical response to government authorities, in conjunction with regulatory to ensure questions around acute therapies are interpreted correctly
Develops clinical documents ensuring scientific excellence. The development process includes writing, interpreting and/or summarizing clinical and non-clinical data, compiling information, leading team meetings, and ensuring delivery within timelines. Clinical documents may include Investigator brochures, clinical study reports, integrated reports, clinical investigation reports, new product submissions. May also include review of case reports and statistical analysis plans, product labels, and response to regulatory agency inquiries.
Maintain current familiarity with the published medical literature related to acute therapy product lines so that information can be incorporated onto various documents created with the organization in compliance with regulations around the world.
Possess an understating and maintain current knowledge of regulatory and quality requirements.
Develop/review annual safety documents (such as PBRER, PSUR, CER, RMP's) and labelling products.
Responsible for coordination, preparation, and/or completion of clinical sections of acute therapy related risk file updates, CCSI or label updates, and other documents as assigned.
Develop and review quality related documents as they pertain to acute therapy products.
Provide clinical support of complaint and adverse event analyses.
Assist Baxter Regulatory Affairs by providing clinical input in to evaluation and response of Ministry of Health (MOH) queries.
Develop expert knowledge of all Baxter Acute therapy products.
Interface with other Baxter function groups such as Clinical, HEOR, Regulatory Affairs, Quality and global business units, as needed.
Work with the team to define project deadlines and monitor project progress to ensure that documents required to support regulatory filings are submitted ion time to regulatory authorities.
Lead or participate in team projects and committees as assigned.
Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable). Includes collaborating with appropriate personnel to ensure documents are publication-ready across the functional teams.
medical, quality, and regulatory experience
Nursing Degree ICU
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to ~~~ and let us know the nature of your request along with your contact information.
Our products and therapies touch the lives of millions of people around the world every day, which is why we are focused on transformative innovations that bring smarter, more personalized care to all of us. For 87 years and counting, we have been at the critical intersection where the ideas that save and sustain lives meet the providers who make it all happen. And now, we are determined to realize our boldest opportunities to transform global healthcare for years to come.