Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.
The Principal Medical Writing Scientist is recognized as a scientific contributor and subject matter expert for clinical regulatory documentation. The Principal Medical Writer will perform all designated writing activities for the medical devices under their responsibility, including clinical evaluation documents, clinical investigation documents, potential publications, and ad hoc regulatory responsibilities. The position is expected to provide leadership and direction to cross-functional teams as well as fellow medical writing colleagues. The Principal Medical Writer will interact closely with the Clinical Strategy, Data Analytics, and Operations teams to ensure that all clinical evidence for selected devices is appropriately communicated.
Impact patient outcomes. Come for a job, stay for a career.
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
Within RTG, the Cranial and Spinal Technologies (CST) division of RTG shapes surgery for the better; delivering cranial, spinal, and orthopedic solutions. We are a leader in therapeutic biologics. We partner with other healthcare stakeholders to accelerate ground-breaking innovations that can improve surgical efficiencies and help create better outcomes for more patients
Responsibilities may include the following and other duties may be assigned.
- Writes and edits manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication.
- Compiles, analyzes, and summarizes additional data from other sources as needed.
- Prepares literature for new products, and revises existing literature.
- Writes and maintains files on informative journal abstracts according to current or estimated future needs.
- Composes medical papers from outlines provided by doctors for presentations.
- May prepare responses regarding company products, drugs, or diseases and refers in-depth technical inquiries to medical personnel.
- Requires knowledge of product areas, current developments, and keeping abreast of current literature.
To be considered for this role, the minimum requirements must be evident on your resume.
- Bachelor’s Degree with a minimum of 7 years of medical/clinical writing/research experience (i.e., developing regulatory documentation and/or scientific/clinical publications or reports) or advanced degree with a minimum 5 years of medical/clinical writing/research experience (i.e., developing regulatory documentation and/or scientific/clinical publications or reports)
Nice to Have (Preferred Qualifications):
- Advanced degree (PhD, PharmD, MD, or MS)
- Experience in medical writing within the medical device, bio-tech and pharmaceutical industry in a related area such as quality, regulatory, clinical research, or product support/R&D.
- Experience and/or working knowledge of cranial and spinal therapies
- Experience performing literature searches in Embase, PubMed and other relevant platforms, with superior ability to appraise and accurately present relevant data/information
- Highly proficient in the use of Microsoft Office suite (Microsoft Word, PowerPoint, Excel), Adobe software (Photoshop, Illustrator), and EndNote Reference Software. Experience with Quosa and/or Distiller preferred..
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).