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Specialist, Medical Writer

Req # JR - 069687 Location San Ġwann tal-Għargħar, San Ġwann, Malta Job Category GST Operations Date posted 08/19/2022

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.

The Job

Summary:

The healthcare industry requires that we abide by regulations from all around the world. Part of the requirements is to produce documents which describe the safety and efficacy of our products. We are looking for individuals to write the clinical section of these documents. The ideal candidates must have a scientific background and be fluent in English (both writing and speaking).

Essential Duties and Responsibilities:

1)  With oversight, develops high quality clinical documents ensuring scientific excellence. The development process includes writing, interpreting and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines. Clinical documents may include investigator brochures, protocols, clinical study reports, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations

2)  Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable).

3)  Work closely with cross functional team members and serve as MW representative at study team meetings.

4)  Prepare document timelines, with guidance from manager.

5)  Develop deep knowledge of specific therapeutic areas.

Who You Are:

Qualifications:

The Medical Writer must demonstrate:

·      Experience in scientific and/or medical writing

·      Experience in the analytical evaluation of scientific data

·      Strong organizational skills and meticulous attention to detail

·      Familiarity with clinical trial-related and regulatory clinical submission templates

The Medical Writer must be able to:

·      Apply global regulatory authority regulations and/or guidance

·      Manage multiple projects with competing priorities

·      Work in a team environment

·      Demonstrate good communication skills

The Medical Writer also should possess knowledge of computer software Microsoft Word and Adobe Acrobat products; Microsoft Project and Visio are a plus.

Education and/or Experience:

The Medical Writer must have a BS or MS in scientific discipline (Biology, Biochemistry, Chemistry) with excellent writing skills.

At least 2 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred.

Reasonable Accommodations

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 [email protected] and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

069687

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