Senior Specialist, Medical Writing

Edwards Lifesciences
Published
November 17, 2022
Location
United States
Category
Other  
Job Type
Work Setting
In-office

Description

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, with a rapidly growing portfolio of innovative and less invasive solutions.

The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.  The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post-market surveillance, leading clinical evidence in THV worldwide.

We have an outstanding, rewarding opportunity for you to join the THV Clinical Affairs team as a Sr Specialist, Medical Writing.  Acting as primary contact for medical writing projects, and working with other cross-functional Edwards departments, you will provide guidance, develop, and lead medical writing projects, timelines, and activities.   

Key Responsibilities

  • Develop complex medical writing documents/deliverables, and provide input on templates for assigned project(s)
  • Serve as the lead for negotiating deliverables, and timelines, and resolving project-related issues in collaboration with cross-functional stakeholders.
  • Conduct literature searches and reviews, including developing search strategies, managing associated documentation, and preparing literature summaries.
  • Act as representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies
  • Lead and provide input on other complex cross-functional deliverables (e.g., risk management review, IFUs, SSED) utilizing technical knowledge
  • Provide leadership, training, and guidance and act as a mentor to less experienced medical writers.
  • Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing
  • Other incidental duties assigned by Leadership
  • 10% travel

Minimum Requirements

  • Bachelor's Degree in a related field and 5 years of related experience in medical writing
  • Master's Degree in a related field and 3 years of related experience in medical writing

Preferred Qualifications

  • Cardiovascular medical device experience
  • Experience writing FDA PMA applications, IDE Progress Reports, and documents for PMA post-approval requirements;
  • Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements
  • Medical writing experience specific to regulations within regulatory affairs scope, in medical device

Additional Skills and General Expectations:

  • Proven expertise in Microsoft Office Suite, including Word, PowerPoint, Access, and Excel
  • Excellent written and verbal communication skills, including customer negotiating and relationship management skills
  • Excellent problem-solving, organizational, analytical, and critical thinking skills
  • Full knowledge and understanding of policies, procedures, and guidelines related to the development of scientific content
  • Full knowledge of medical writing
  • Good leadership skills and ability to influence change
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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