Medical Writer
Salary undisclosed
Apply on
Original
Simplified
Minneapolis, MN, USA Req #403
Tuesday, October 1, 2024
At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world’s largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients’ lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.
Position Title: Medical Writer
Additional Info: Locations: Remote
A Day In The Life
In this exciting role as a Medical Writer on the Clinical and Medical Affairs Team, you will primarily focus on creating and maintaining Clinical Evaluation Plans and Reports (CEP, CER), Periodic Safety Update Reports (PSUR), and Summary of Safety and Clinical Performance (SSCP) Reports. In this role, you will be part of a collaborative team to author these deliverables via providing clinical expertise in technical writing. This is a dynamic opportunity that will provide exposure to varied Clinical evidence opportunities and cross-functional interactions with regulatory, quality, marketing and other functions.
Responsibilities
Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life.
It’s essential our team members feel valued, supported and empowered too. That’s why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work – helping you reach your potential and enjoy a career full of life-changing possibilities.
Physical Job Requirements
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)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this the position you were waiting for? Apply here!
Other details
Tuesday, October 1, 2024
At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world’s largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients’ lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.
Position Title: Medical Writer
Additional Info: Locations: Remote
A Day In The Life
In this exciting role as a Medical Writer on the Clinical and Medical Affairs Team, you will primarily focus on creating and maintaining Clinical Evaluation Plans and Reports (CEP, CER), Periodic Safety Update Reports (PSUR), and Summary of Safety and Clinical Performance (SSCP) Reports. In this role, you will be part of a collaborative team to author these deliverables via providing clinical expertise in technical writing. This is a dynamic opportunity that will provide exposure to varied Clinical evidence opportunities and cross-functional interactions with regulatory, quality, marketing and other functions.
Responsibilities
- Reports instances of complaints/adverse events from literature to GCH.
- Create responses for audit/submission queries.
- Maintains database of peer-reviewed literature.
- Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
- Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
- Develop state of the art on product family for its intended purpose.
- Create & maintain plans and reports for regulatory authorities.
- Review/approve other documentation for device development.
- Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
- Bachelor degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
- Advanced degree (PhD, PharmD, MD or MS)
- Medical writing and/or clinical research experience within a medical device industry
- Experience with European Union Medical Device Regulations (EU MDR); Proficiency in MEDDEV
- Experience conducting literature searches and literature reviews
- Experience in functions such as clinical, regulatory, medical affairs, quality, research, and medical safety
- Ability to critically analyze and interpret scientific data (clinical and preclinical).
- Experience with medical writing tools and database (e.g., Endnote, Cite-While-You-Write) and technical publication tools (i.e., Adobe Acrobat, Publisher, MS Project)
- Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint)
Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life.
It’s essential our team members feel valued, supported and empowered too. That’s why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work – helping you reach your potential and enjoy a career full of life-changing possibilities.
Physical Job Requirements
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)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this the position you were waiting for? Apply here!
Other details
- Job Family Medical Writing
- Job Function Clinical
- Pay Type Salary
- Employment Indicator Regular
- Min Hiring Rate $69,375.00
- Max Hiring Rate $115,625.00
- Required Education Bachelor’s Degree
Similar Jobs
