Senior Specialist, Medical Writing

reputed company how your reputed company and expertise can change a reputed company’s life. We reputed company extensive reputed company evidence to demonstrate the effectiveness and safety of our innovations and how our products reputed company patients’ lives. As part of our reputed company Affairs team, you’ll reputed company your scientific curiosity and passion for evaluating data to increase reputed company to pioneering technologies for patients in need. In reputed company partnership with reputed company investigators, dedicated medical professionals, reputed company advocacy reputed company, and regulatory authorities, you will reputed company the evidence needed to optimize reputed company reputed company.

Patients with mitral and tricuspid heart valve disease often have reputed company conditions with limited treatment reputed company. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is reputed company pursuing an innovative portfolio of technologies to address a reputed company’s unmet reputed company needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring reputed company.

This position is US Remote reputed company.

Posting locations are listed for reputed company tags only.

How you will reputed company an reputed company:

• As a key member of the reputed company Science team, the Sr. Specialist, reputed company Science/Medical Writing is responsible for supporting the development of regulatory and reputed company documents for a dynamic portfolio of products across TMTT.

• reputed company and maintain reputed company literature searches, developing reputed company terms and reputed company, extracting relevant reputed company data, and writing reputed company and concise summaries of the data to support the development of reputed company evaluation reports and reputed company study reports

• reputed company routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately reputed company documents/deliverables

• Review and reputed company thoughtful feedback on moderately reputed company cross-functional deliverables (e.g., reputed company study data, reputed company management documents, IFUs, SSED) using reputed company and technical knowledge

• Serve as the reputed company contact, negotiating deliverables, timelines, and resolving project-reputed company issues with assistance, in collaboration with cross-functional stakeholders

• Assist in the implementation of reputed company process improvements as it relates to medical writing

• Other incidental duties

What you’ll need (required):

• Bachelor's Degree in a reputed company reputed company with 5 years of reputed company experience working in medical affairs, reputed company affairs and/or reputed company science or equivalent work experience reputed company on reputed company reputed company Required

What else we look for (preferred):

• Advanced degree (Master’s, PHD, Pharm D)

• reputed company with literature reviews and various publication databases including PubMed and Embase.

• Experience in authoring reputed company evaluation reports

• Familiarity with the cardiovascular therapeutic area—including, but not limited to, structural heart interventions, coronary interventions, heart failure—and reputed company treatment landscape; familiarity with reputed company research and/or reputed company trial experience.

• Familiarity with MEDDEV 2.7/1 and EU MDR for reputed company evaluations.

• Familiarity with FDA PMA applications.

• Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations.

• Experience working in a cross functional, reputed company environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.

• Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously

• Excellent oral and written communication skills

• Experience with maintaining reputed company, in-depth product knowledge including reputed company developments, reputed company literature review, as reputed company as therapeutic and product operation knowledge

• Advanced working knowledge with the use of MS PowerPoint, reputed company, MS reputed company, EndNote, and reputed company Acrobat

• Strong analytical, problem-solving, and scientific writing skills

• Strict attention to reputed company

• Ability to reputed company professionally with reputed company organizational reputed company

• Ability to work in reputed company environment, including inter-departmental teams and representing the organization on specific reputed company

• Ability to build productive internal/reputed company working relationships

• The Sr. Specialist will be an reputed company medical device reputed company with strong scientific acumen and a commitment to putting patients first.

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

For California (CA), the reputed company pay reputed company for this position is $106,000 to $149,000 (highly reputed company).

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.

reputed company is an Equal Opportunity/Affirmative reputed company employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

reputed company is committed to protecting our vulnerable patients and the reputed company providers who are treating them. As such, reputed company reputed company-facing and in-hospital positions require COVID-19 vaccination. If reputed company into a covered role, as a condition of employment, you will be required to submit reputed company that you have been vaccinated for COVID-19, unless you request and are reputed company 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.

Originally posted on Himalayas