Manager, Medical Writing, Regulatory Affairs

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.The Manager, Medical Writing will provide guidance, develop, and lead medical writing projects, timelines and activities.This role can be an onsite or a hybrid role based at the Irvine headquarters, or a remote role based in the U.S.How you will 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., Clinical Affairs, Quality, R&D, 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 a related field and 8 years of related scientific experience OR

Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in a related field and 6 years of related scientific experience

What else we look for (Preferred) :

Experience as a medical writer for a medical device company, cardiovascular medical device company highly preferred

Extensive experience authoring:

EU Clinical Evaluation Plans and Reports (CEP, CER, respectively) in compliance with applicable regulations/guidances (e.g., MDD 93/42/EEC as amended by 2007/47/EC, MED DEV 2.7/1, rev 4, MDR 2017/745, MDCG 2020-1, MDCG 2020-5, MDCG 2020-6)

Postmarket Clinical Follow-up Plans and Reports (e.g., MEDDEV 2.12/2, MDCG 2020-7, MDCG 2020-8),

Summary of Safety and Clinical Performance (MDCG 2019-9), etc.),

Any other applicable reports

Extensive knowledge on conducting focused searches within medical literature databases (e.g., PubMed, Medline)and ability to evaluate/summarize content

Ability to discuss complex scientific and technical subjects with stakeholders

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 prooing 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

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

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.The base pay range for this position is $120,000 to $170,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.