Medical Writing Assistant Jobs in Kentucky (NOW HIRING)

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinicalevidence to demonstrate the effectiveness and safety of our innovations and how our productstransform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity andpassion for evaluating data to increase access to pioneering technologies for patients in need. In closepartnership with principal investigators, dedicated medical professionals, patient advocacy groups, andregulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR)pioneered an innovative, life-changing solution for patients by offering heart valve replacement withoutthe need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partnerwith cardiologists and clinical teams to transform patient care with devices supported by clinicalevidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of ourinspiring journey.

The Senior Specialist, Medical Writing will 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 and timelines and resolving project-related issues in collaboration with cross-functional stakeholders

• Conduct literature searches and reviews, including developing search strategy, managing associated documentation, and preparing literature summaries.

• Act as representative in core team meetings in the development of reporting plans and regulatory submissions (US, EU, and international) for clinical studies

• Lead and provide input on other complex cross-functional deliverables (e.g., risk management review, IFU, 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

• Bachelor's Degree in related field with 5 years of previous related experience in medical writing or equivalent work experience based on Edwards criteria

• Graduate degree (e.g., MS PhD) in life science, engineering, or related field

• Experience with clinical evaluation report (CER) development under MEDDEV 2.7/1 REV. 4 and/or the European Union Medical Device Regulation (EU MDR)

• Proven expertise in Microsoft Office Suite, including Word, Excel and PowerPoint, and publication library software (e.g., ENDNOTE) and database systems (e.g., PubMed)

• 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 and 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 contacts representing the organization on projects

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 $108,000 to $153,000 in total (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.