The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
We have an outstanding, rewarding opportunity for you to join Edwards as an Associate Manager, Medical Writer . You will provide guidance, develop, and lead medical writing projects, timelines and activities.
This position is remote and can be located anywhere in the United States.
Responsibilities include, but not limited to:
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.)
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 medical writing projects and/or initiatives.
Provide mentoring and knowledge transfer for Medical Writing team members
Act as a representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies
Bachelor's Degree in related field with 8 years of related scientific experience OR Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in related field with 6 years of related scientific experience;
Experience as a medical writer
Experience with CERs (Clinical Evaluation Reports) - EU preferred
Demonstrated ability to discuss complex scientific and technical subjects with stakeholders
Demonstrated ability to provide leadership and guidance; skilled in coaching and training techniques
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)
Extensive editing and proofreading skills
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Experience with PMAs (Pre Market Approvals) - FDA
Experience as a medical writer for cardiovascular or medical device company preferred
Additional Talents and General Expectations:
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 $117 000 to $137 000.
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences Corp