Manager, Scientific Affairs




ID 2021-3323
Job Locations US-CA-Redwood City
Job Post Information* : Posted Date 13 hours ago
Category Clinical & Regulatory


More information about this job:

About Nevro
Nevro (NYSE: NVRO) is a public multinational medical technology company headquartered in Redwood City, California. We have developed HF10 therapy, an innovative, evidence-based neuromodulation platform.

We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has impacted the lives of over 28,000 patients around the world.

The Nevro Senza SCS System received CE mark in 2010, TGA approval in 2011, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States.

Job Summary & Responsibilities
This position will be responsible for leading Nevro's publication strategy and supporting clinical research initiatives. This role shall manage the medical writing needs for peer reviewed publications, regulatory deliverables and scientific communications. Focus on developing, managing and executing publication pipeline for Nevro therapy, supporting design of clinical studies analyzing and disseminating the generated evidence.

Role Requirements
Publications/Medical Writing
  • Lead Nevro's scientific publications strategy, key initiatives/global evidence communications and develop annual publication plans in collaboration with key global stakeholders
  • Lead tactical execution of publication plans (ie, clinical manuscripts, abstracts, posters, and oral presentations), meeting established timelines and budgets.
  • Manage and supervise medical writers (internal/external) including contractual aspects, onboarding and engagement.
  • Collaborate with clinical, regulatory and commercial organizations to support scientific publications and regulatory deliverables.
  • Support the upkeep of the clinical research reference library including developing structure for indexing
  • Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments
  • Support the marketing team to curate competitive intelligence, to create social media assets and support distribution of published evidence
  • Lead collaborations with KOLs and medical experts to plan and execute strategic/technical publications
Clinical Research
  • Organize and analyze data from clinical research studies.
  • Plan for, and participate in clinical research meetings.
  • Collaborate with clinical project/program managers and data management team.
  • Participate in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate.
  • Represent Nevro at conferences and present clinical data.
  • Provide feedback and support regulatory submissions for US/OUS market access, especially technical documentation including Clinical Evaluation Reports (CER), Post Market Clinical Follow Up (PMCF) plans etc.
  • Communicating with internal and external collaborators on executing scientific proposals including sponsored studies, investigator-initiated studies etc.
  • Interact with internal /external audit stakeholders, regulatory agencies' representatives etc. as needed.


Skills and Knowledge
  • MS. or Ph.D. Degree in science/health/engineering (e.g., Neuroscience, and/or Biomedical Engineering preferred).
  • 5+ years' experience in clinical/scientific research, medical devices/pharmaceutical clinical trials, plus 2+ years' experience working in medical writing.
  • Strong data analysis skills including proficient use of Excel, statistics tools, Adobe Illustrator.
  • Good understanding of the medical concepts, terminology and spinal cord stimulation.
  • Understanding of US/OUS regulatory affairs. RAC certification is a plus.
  • Understanding of research methodology, medical device regulations (US/OUS) and guidelines (ISO14155; MEDDEV 2.7/1 Rev 4 etc.), and product knowledge, to support technical documentation for CE Marking.
  • Experience managing KOL relationships




Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.



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PI145144603



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Company
Nevro
Posted
08/29/2021
Location
Redwood City, CA 94061, US