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Manager, Medical Writing

3 weeks ago

Irvine, California, United States Edwards Lifesciences Full time

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you'll make an impact:

  • Plan, develop and lead the completion of complex medical writing projects in a fast-paced environment with accountability for successful completion within scope of project deliverables including negotiating deliverable timelines, and resolving project-related issues with cross-functional partners (e.g., Regulatory Affairs, Quality, Clinical, Biostatistics, etc.)
  • Act as a technical expert to key stakeholders to develop and lead the implementation of corporate, business unit, and departmental process updates and improvements (e.g., MDR compliance, etc)
  • Provide direction and guidance for executing medical writing projects and/or initiatives.
  • Provide mentoring and knowledge transfer for Medical Writing team members
  • Lead the identification, recommendation and implementation of continuous process improvements as it relates to medical writing
  • Other duties as assigned

What you'll need (Required):

  • Bachelor's Degree in related field, with 8 years experience of related scientific experience Required or equivalent work based on Edwards criteria
  • Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in related field, with 6 years experience of related scientific experience Required

What else we look for (Preferred):

  • Medical Device experience
  • Experience with Clinical Evaluation Plans and Report, Post-market Clinical Follow-up Plans and Reports, and Summary of Safety and Clinical Performance
  • Extensive knowledge of EU regulations/guidances (e.g., MDD 93/42/EEC, MEDDEV 2.7/1, rev 4, MDR 2017/745, MDCG 2020-1, MDCG 2020-5, MDCG

  • Experience as a medical writer for cardiovascular structural heart experience

  • Familiar with Distiller software system

  • Ability to discuss complex scientific and technical subjects with stakeholder
  • Ability to provide leadership and guidance; skilled in coaching and training techniques
  • Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote) and database systems (e.g., Medline or PubMed)
  • Extensive editing and proofreading skills
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
  • Extensive understanding of related aspects of the medical writing processes and/or systems
  • Extensive knowledge on conducting focused searches within medical literature databases (e.g., PubMed, Medline) and ability to evaluate/summarize content
  • Knowledge of biomedical statistics
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Ability to represent leadership on sections of projects within a specific area interfacing with project managers and cross-functional teams
  • Ability to consult in a project setting within specific sections
    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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $123,000 to $174,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.