Associate Medical Writer
Location:
Bangalore, Karnataka, India
Requisition #:
21000TPQ
Post Date:
23 hours ago
Careers that Change Lives:
The Associate Medical Writer in our Medical Affairs organization supports the Global Neurovascular (NV) operating unit. This Writer will help support development of clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards.
A Day in the Life:
Support the development and completion of Clinical Evaluation Reports (CERs); as part of design validation for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs
Support Clinical Risk Benefit Analysis (CRBAs); to support risk management activities
Support clinical study reports (CSRs); provide support with submissions to regulatory agencies by drafting clinical sections of global submissions (eg, IDE, PMA)
Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies
Conduct literature searches and clinical evidence mapping, manage the literature database, and prepare literature reviews for external and internal stakeholders
Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders
Must Have: Minimum Requirements
Bachelors degree with minimum 1 years of experience in the medical device/pharmaceutical field
Nice to Have:
Experience in the development of clinical, scientific, and regulatory documents
Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
Demonstrated ability to meet project goals within a matrix environment; excellent project management, communication, and organizational skills
Understanding of global regulatory agencies and regulatory processes concerning medical devices
About Medtronic
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 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 Amer
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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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