Sr Specialist, Medical Writing

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.

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.

How you'll make an impact:

• Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines.

• Develop complex medical writing documents/deliverables, and provide input on templates for assigned project(s)

• Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders

• Conduct literature searches and reviews, including developing search strategy, manage associated documentation, and prepare 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., Overall Benefit-Risk Assessment, IFUs, SSCP) 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

What you'll need (Required):

• Bachelor's Degree in related field Plus 5 years of previous related experience in medical writing Required Or

• Master's Degree in related field Plus 3 years of previous related experience in medical writing Required 

What else we look for (Preferred):

• 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

• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel

• 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

• Strict Attention to detail

• 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.

The base pay range for this position is $106,000 to $149,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.    

Edwards 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.