Senior Clinical Evaluation Medical Writer
Senior Clinical Evaluation Medical Writer
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Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
In this exciting role a Senior Medical Writer on the Clinical Evidence team will support General Surgical Technology business. The primary responsibilities are creating and maintaining Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance report (SSCP) and Periodic Safety Update Reports (PSUR) etc. that support the presentation publication regulatory clinical document submission needs of assigned therapeutic areas including class III and implantable medical devices). This is a dynamic opportunity that will provide exposure to clinical opportunities and cross-functional interactions. May write and edit manuscripts or abstracts 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. Collaborates with cross-functional team members daily with the ability to provide solution orientated recommendations.Our Surgical OU is one new powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. Led by Mike Marinaro and his new leadership team well approach the market with a unified approach from concept single strategy capitalize on our global commercial capabilities and prove the power of our combined portfolio.
Responsibilities may include the following and other duties may be assigned.
- This role predominantly focuses on writing editing and reviewing regulatory (e.g. Clinical Evaluation Reports/clinical study reports/summaries/Summary of Safety and Clinical Performance / Periodic Safety Update Report etc.) documents and responses to Notified Bodies.
- Post Market Surveillance activities (monthly literature review of our product)
- Conduct proofreading editing document formatting review comment integration and document completion / approval activities
- Collaborate with cross-functional team to assure high quality and successful project delivery
- Seek out and engage regularly with peers creating an environment of exchange and learning.
- Openly share successes and failures to promote the groups collective learning. Administration of the applicable databases for the activities related to the evaluation of clinical data Clinical Evaluation reports and Post Market surveillance reporting.
- Create and manage project schedules for each clinical evidence document.
- Compiles analyzes and summarizes additional data from other sources as needed.
- Prepares literature for new products and revises existing literature.
Must Have: Minimum Requirements
- Bachelors Degree with a minimum of 4 years of medical or clinical writing experience or a Masters degree with 2 years of medical or clinical writing experience.
Nice to Have
- Masters or PhD degree(s) in biomedical sciences or technical disciplines
- Experience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical Evaluation Reports and post market surveillance reporting.
- Clinical research experience.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
It 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Senior IC
Employment Type
Full-Time
