Analyst, Medical Affairs

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Your Role at Baxter

This is where your work saves lives. The work we do in developing, coordinating and maintaining EU MDR-compliant clinical deliverables helps to improve outcomes for patients around the world. As an EU MDR Deliverables Project Lead at Baxter, your work contributes directly to making a significant impact on others. It's challenging work—and you're not on your own. Our teams collaborate cross-functionally and lead by influence.

This is where your desire to make a meaningful difference in others' lives can come to reality. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.

When you join Baxter as an Analyst, Medical Affairs, you'll drive successful execution within established budgets and timelines while ensuring consistency with regulations, quality standards, commitments, and goals. Agile and willing to take action, you stay calm under pressure.

Your Team

While everyone at Baxter has a shared passion for our mission, this team plays a critical role in our ability to save and sustain lives.

We courage teamwork and collaboration and prioritize building relationships with each other. It's easy to do because we all share common traits of reliability, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable.

Baxter understands that learning and development are important. Whether it's training, striving toward a promotion, or gaining experience with other portfolios or business units, Baxter leaders frequently speak with their teams about how employees are trying to grow and how they can support those efforts. With the ability to chart your own path, the development opportunities are endless.

What you'll be doing

• Manages the schedule for their assigned MDR/MDD deliverable projects to comply with deadlines as provided by project management.
• Reports out to project management and leadership (as needed) on the status of their projects.
• Coordinates provision of latest issued and effective internal reference documents and supporting data to Medical Writer.
• Facilitates communication between Medical Writer and internal subject matter experts to resolve questions during the deliverable drafting process.
• Liaises with other functional units (Engineering, Marketing, Quality, Regulatory, Medical Affairs, Global Patient Safety, and Marketing) to facilitate timely and appropriate reviews of MDR/MDD deliverables.
• Escalates project roadblocks to leadership appropriately.
• Routes documents for approval and release within the quality management system.
• Ultimately responsible for driving the effort in successfully delivering the required documents by the required timelines. If anything places that delivery at risk, collaborates with cross-functional business partners to mitigate that risk. Anticipates potential deliverable schedule conflicts and challenges for proactive solutions and manages deliverable schedule. Ensures escalation of any unresolved deliverable delays to leadership within WWM, as well as SME Leadership Team.
• Implements an effective communication model with cross-functional team members that provides deliverable status updates and supports timely completion of deliverables.
• Performs other duties and projects as assigned.

What you'll bring

• Bachelors degree in a related field.
• Ability to review and assess quality of documents against requirements outlined in established procedures.
• Proficient in Excel, Word, Outlook, PowerPoint, & SharePoint.
• Strong project management skills with ability to multi-task and manage multiple projects in parallel.
• Ability to communicate directly with internal stakeholders including cross functional leadership.
• Strong interpersonal skills; demonstrated success partnering with individuals to build relationships with stakeholders.
• Knowledge of EU MDR/MDD requirements, preferred

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Additional qualifications include:

• Expertise in project leadership
• Excellent oral and written communication skills
• Review all deliverables for compliance to SOPs
• Strong organizational skills, attention to detail, and business acumen
• Must possess knowledge and expertise in Microsoft Word, Microsoft Excel,
• Microsoft Project, and Adobe Acrobat products. Knowledge in Microsoft Visio
• is a plus.
• Must have a flexible mindset, able to work in a fast-changing environment
• with competing priorities
• Able to problem solve and resolve issues/obstacles to success
• Facilitates communication between the WWM-Strategy & Delivery Team, product teams (SMEs), and the Medical Writer (internal or external vendor) to ensure successful, on-time completion of the following deliverables owned by WWM that are required for CE-marking in the EU and Rest of World (ROW).
• Clinical Evaluation Plans (CEP)
• Clinical Evaluation Reports (CER)
• Post-Market Clinical Follow-up Plans (PMCFP)
• Periodic Safety Update Reports (PSUR)
• Post-market surveillance Plan (PMSP)
• Post-market surveillance Report (PMSR)
• Summary of Safety & Clinical Performance (SSCP), when applicable.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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