Senior Clinical Evaluation Medical Writer
3 weeks ago
Job Title: Senior Clinical Evaluation Medical Writer
Job Location: Hyderabad, Telangana, India
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life
The medical writer combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the MEDDEV 2.7/1 Rev 4 and EU Regulation 2017/745. The medical writer will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit profile of a device or devices. Moreover, the writer may be requested to contribute to other activities such as drafting of clinical summaries of literature articles and interacting with regulatory agencies' representatives as needed.
Responsibilities may include the following and other duties may be assigned:
- Independently creates and maintains Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), Post Market Clinical Follow Up Reports (PMCFR) and Summary of Safety and Clinical Performance [SSCP] for medical devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance documents and applicable Medtronic procedures and templates.
- Identifies, evaluates, appraises, analyzes, summarizes and synthesize clinical evidence including data from sources such as preclinical studies, clinical investigations, literature, and other post-market surveillance sources. Analyzes results in preparation for product applications and submissions.
- Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence. Review and summarize scientific literature (e.g. screens articles against inclusion/exclusion criteria, analyzes and appraises the quality, suitability and relevance of the included studies, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports).
- Reports instances of complaints/adverse events from literature to GCH.
- Create responses for audit/submission queries.
- Maintains database of peer-reviewed literature.
- Develop state of the art on product family for its intended purpose.
- Review/approve other documentation for device development.
- Reviews IFUs, Risk Management files and other cross-functional documents to ensure alignment of risk information.
- Knowledge of regulatory agencies' guidelines on clinical evaluation requirements.
- Clearly and timely communicates timelines, required inputs for projects, project risks, etc. with cross-functional stakeholders.
- Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
- May have broad knowledge of project management.
- Requires a Baccalaureate degree and total 8 years of experience with minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
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.
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.
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 90,000+ 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
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/65810fbc22ef54c3e27aa0cddc05d62d
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