Manager, Medical Writing (Remote, USA) Surgical

Manager, Medical Writing (Remote, USA) SurgicalStructural Heart

Edwards Lifesciences has an exciting opportunity with in our Regulatory Affairs team of our Surgical Structural Heart group, focused on transforming patients' lives by advancing surgical structural heart innovations.

The Manager of Medical Writing will provide guidance, develop, and lead medical writing projects, timelines and activities. The current primary goal is authoring or supporting CERs (Clinical Evaluation Report and associated methods), and supporting EU MDR clinical requirements.

Key Responsibilities:

• Plan, develop and lead the completion of complex medical writing projects PMAs (Pre Market Approvals), MDRs timelines and activities 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.)

• 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 smaller projects to execute tactical medical writing projects and/or initiatives. Provide mentoring and knowledge transfer for Medical Writing team members

• Other duties as assigned

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 as a medical writer for a cardiovascular / Class III implantable medical device company

• Experience authoring or supporting CERs (Clinical Evaluation Report and associated methods)

• Experience with EU MDD and EU MDR

Additional Skills:

• 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)

• 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 knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques

• Extensive understanding of related aspects of the medical writing processes and/or systems

• Extensive knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)

• Extensive editing and proofreading skills

• Extensive knowledge of biomedical statistics

• Extensive knowledge of US FDA and EU Medical Device Regulation requirements for the submission of pre- and post- market clinical trial data and reports.

• Strict attention to detail

• Strong results orientation and adherence to confidentiality

• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

• Ability to manage competing priorities in a fast paced environment

• Ability to discuss complex scientific and technical subjects with Investigators and KOLs

• Ability to provide leadership and guidance; skilled in coaching and training techniques

• Ability to represent leadership on sections of projects within a specific area interfacing with project managers and product development team

• Ability to consult in project setting within specific sections of clinical trial design, methods and data dissemination

• Ability provide project specific leadership to outsourcing partners on a task level

• Adhere to all EHS rules and requirements 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

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

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.