Sr Medical Writer

☞ Medtronic

View: 111

Update day: 30-05-2024

Location: Mumbai Maharashtra

Category: Health / Medical Care Pharmacist / Pharmaceutical representatives Science Labor

Industry: Pharmaceutical Biotechnology

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Job content

Careers that Change Lives

The Medical Writer in our Medical Affairs organization supports the Global Neurovascular (NV) operating unit. This Writer will develop clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards.



A Day in the Life:

Responsibilities may include the following and other duties may be assigned.

  • Lead 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
  • Collaborate with the Quality organization and perform Clinical Risk Benefit Analysis (CRBAs) to support risk management activities
  • Work in a cross-functional team and draft 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 agenciessubmissions (eg, IDE, PMA)
  • Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies
  • Collaborate with Regulatory Affairs and provide support to respond to questions from regulatory agencies
  • For all documents, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers
  • Conduct literature searches and clinical evidence mapping, manage the literature database, and prepare literature reviews for external and internal stake holders
  • 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:

  • Advanced degree in a scientific discipline (Ph.D., MD, or Pharm. D.) preferably with 7-10 years’ experience in the medical device/pharmaceutical field
  • 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 and organizational skills
  • Understanding of global regulatory agencies and regulatory processes concerning medical devices

Nice to Have:

  • Ability to understand and interpret results of published literature and clinical studies; working knowledge of statistics is required
  • Ability to summarize complex results and present in a clear, concise, and scientifically accurate manner to a wide-range of audiences
  • Excellent writing and editing skills, and a keen attention to detail
  • Strong verbal, written, and interpersonal communication skills
  • Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment
  • Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases

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. Let’s 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

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Deadline: 14-07-2024

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