Clinical Evaluation Medical Writer
Clinical Evaluation Medical Writer
Medtronic
Job description
Interested in a career in clinical evaluation and regulatory medical writing? Explore the Clinical Evaluation Medical Writer position at Medtronic in Nanakramguda, Hyderabad.
About the Company
Medtronic is a healthcare technology firm innovating to treat more people, in more ways, than ever before. Its purpose is to relieve pain, restore health and prolong life. The company operates in more than 150 countries and creates solutions to help patients and improve healthcare results.
Job Description
This is a full time position situated out of Nanakramguda, Hyderabad with flexible work arrangement. The position entails the development of Clinical Evaluation Plans and Reports, Summary of Safety and Clinical Performance reports, Periodic Safety Update Reports and other clinical and regulatory documentation. This also includes evaluation of clinical evidence, literature searches, regulatory tracking and supporting paperwork for Class III, implantable, Class IIb and Class IIa medical devices.
Main duties
Prepare, evaluate and modify key clinical and regulatory papers e.g. Clinical Evaluation Reports, clinical trial reports or summaries, SSCP reports, PSURs and responses to Notified Body queries;
Respond in a timely and correct manner to inquiries relating to audit and regulatory submissions.
Perform thorough scientific literature searches and critically appraise clinical evidence from available sources.
Analyze, summarize and discuss clinical data for use in clinical evaluation documentation.
Maintain databases of relevant peer-reviewed research and clinical evidence
Develop state-of-the-art assessments for assigned product groups based on planned use.
Prepare and edit papers, abstracts, scientific reports, monographs, comprehensive reviews, scientific exhibitions and other medical communication materials as needed.
Work with cross-functional teams to gather and analyse information relevant to medical device safety and performance and provide solution-oriented recommendations.
Keep abreast of changes in safety rules, guidance documents and industry expectations to promote ongoing compliance.
Apply necessary regulations and standards including ISO 13485, ISO 14971, EU MDR and applicable product specific industry norms.
Independently find, evaluate, and interpret clinical information from scientific papers and other credible sources.
Education Qualification
Candidates must have one of the following essential qualifications:
B.Pharm/ M.Pharm
MSc in Pure or Applied sciences
Other related Post Graduate Qualifications in Life Science
Skills
Medical and regulatory writing for clinical documentation
Familiarity with US and EU Quality Systems regulations
Knowledge of ISO 13485 and ISO 14971
Knowledge of 21 CFR Part 820 & 21 CFR Part 11
Knowledge of EU MDR and relevant product specific requirements
Scientific literature search and critical appraisal of clinical evidence
Excellent written and verbal communication abilities
Well organized and good planning skills
Strong eye for detail
Ability to manage multiple priorities in time sensitive deadlines
Experience working with multinational, cross-functional teams is a plus.
Relevant medical writing certification is preferred for this role.
Salary
The average income of a Medical Writer Clinical Evaluation in India is ₹10 Lakhs -18 Lakhs per year.
Career Development
It can enhance skills in clinical evaluation, regulatory medical writing, scientific evidence assessment, and medical device regulations. Experience with global standards and cross-functional teams can help with development into broader clinical, regulatory or medical writing roles.
Application Process
Check out our employment portal for the Clinical Evaluation Medical Writer role
Open the listing to get the full job information and eligibility conditions.
Fill in your details and upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.