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.
How you'll make an impact:
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
What you'll need (Required):
What else we look for (Preferred):
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.
