Job Title Senior Medical Writer
Location: Minneapolis, MN, 55405, USA
Senior Medical Writer
Minneapolis, Minnesota, United States
Mar 27, 2018
**Careers that Change Lives**
**A Day in the Life**
This is a Medtronic medical writing position in Implantable Therapies Clinical Research for the Restorative Therapies Group. The Senior CER Specialist will have an in-depth knowledge of medical writing and will be responsible for developing Clinical Evaluation Reports (CERs) and assessing the need for product change CERs. This individual will have demonstrated expertise in partnering with clinical research, regulatory affairs, quality/reliability, product development, and biostatisticians to develop schedules and timely execute tasks. The individual will have demonstrated the ability to develop solutions to complex problems and ensures that solutions are consistent with objectives. The individual will have a broad expertise in collaborating on a number of clinical and regulatory documents. The role includes management of the clinical evidence report writing process to ensure compliance to regulations and expectations of Regulatory Bodies.
Responsibilities may include the following and other duties may be assigned.
Analyze and synthesize vast amount of pre-clinical data, risk management assessments, published literature, clinical investigation results and field performance data in order to evaluate product safety and performance.
Interface with key functional areas (eg. Product core teams, clinical team, EU and US regulatory, marketing and risk management group) to obtain necessary information and documents required for the development of CERs.
Develop therapeutic and device operation knowledge and apply this knowledge to clinical assessment and development of evaluation reports for corresponding product/s.
May participate and/or facilitate meetings with health care professionals, consultants and internal scientific or tactical committees.
Provide input and feedback to product core teams/members/teams in the determination of appropriate clinical evaluation strategy, and may provide input and direction to project teams in order to arrive at a sound clinical evaluation.
May interface with regulatory agencies to discuss details of the clinical evaluation report, including clinical assessment results
Collaborate with cross-functional team to assure high quality and successful completion of deliverables
Critically evaluate project progress and metrics. May collaborate with cross functional team to identify risks and mitigation plans
Manage project schedule, timelines and deliverables
May conduct literature review searches, ordering articles, conducting article reviews, and creating bibliographies
May maintain metrics for articles searches
Participate in process improvement initiatives
**Must Have: Minimum Requirements**
- 5 years experience (4 years with Masters or 3 with Doctorate, or Board Certified MD or DVM)
- Medical writing experience
**Nice to Have**
- Clinical Research experience
- Medical device experience
- Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)
- Advance degree in related field (i.e. systems, reliability, safety engineering)
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. Lets 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 Day in the Life 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 ************ is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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Website : http://www.medtronic.com/
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Groups products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.