Manager, Medical Writer/Clinical Science (Remote, USA) TMTT

Manager, Medical Writer/Clinical Science (Remote, USA) TMTT

We are seeking talented and passionate professionals to join this fast-paced, dynamic team to play a pivotal role in the development of new therapies and devices, from concept through to human use.

The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization.

As a key member of the Clinical Science, Medical Affairs team, the Manager is responsible for providing scientific expertise throughout the development and implementation of clinical evaluations and/or clinical studies for a dynamic portfolio of products across TMTT. The Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.

Note: This position is internally titled as a Manager, Medical Affairs and is an individual contributor (SME) role.

Essential Job Functions/Key Responsibilities:

* 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 Project Managers, Clinical Data Management, Biostatistics, etc.).
* Author clinical evaluation plans (CEPs), clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) plans and reports, pre- and post-market clinical trial protocols, study reports (e.g., annual progress reports, clinical study reports), regulatory responses, and other scientific documents.
* Partner with TMTT R&D, Clinical Affairs, Safety, Regulatory Affairs, QA, Biometrics, GHER (Global Health Economics & Reimbursement) and other subject matter experts to create documents and that effectively and clearly describe research results, product use, and other medical information.
* Provide scientific support by interpreting safety and effectiveness results data, including data mining, compiling, analyzing, and summarizing data from all applicable sources.
* Independently review and collaborate with cross-functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting.
* Act as a Clinical Science representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies.
* Provide training and guidance and act as a mentor to less experienced medical writers.
* Identify, recommend, and assist in the implementation of continuous process improvements related to medical writing.
* Summarize key clinical evidence from published literature and provide updates to internal stakeholders (as appropriate)
* Correctly analyze clinical data/results and interpret outcomes to propose appropriate follow-up.

Minimum Requirements:

* Bachelor's Degree with 8 years of medical writing or related scientific experience OR
* Master's with 6 years of medical writing or related scientific experience OR
* Doctorate with 4 years of medical writing or related scientific experience

Preferred Qualifications

* Experience in industry Class III medical device medical writing
* Familiarity with the coronary interventional and structural heart fields and current treatment options or have other clinical and/or clinical trial experience.
* Experienced in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations.
* Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously
* Demonstrated experience with maintaining current, in-depth product knowledge including current developments, clinical literature reviews, as well as therapeutic and product operation knowledge
* Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations is highly desirable.
* Experienced with literature reviews and various publication databases including PubMed and Embase.
* Ability to manage competing priorities in a fast-paced environment.
* Experience working in a cross functional, collaborative environment.
* Ability to interact professionally with all organizational levels.
* Excellent written and verbal communication skills, including negotiating and relationship management skills.
* Excellent problem solving, organizational, and analytical critical thinking skills.
* Good leadership skills and ability to influence change.
* Strict attention to detail.
* Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat.
* Strong analytical, problem-solving, and scientific writing skills.

Additional Talents and General Expectations:

* Ensure documents comply with regulatory guidelines.
* Direction tends to be high level and focused on end results with means of accomplishment left to the individual contributor.
* Up to 15% travel to conferences/physician meetings.

For Colorado Residents Only:

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 $132,000 to $154,000.

Additional information can be found through the link below:

https://www.edwards.com/careers/benefits

#LI-REMOTE

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

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.