Senior Specialist, Medical Writing

This is a fully remote position, open to applicants in Mississippi.

📋 Description

• Create intricate medical writing documents and deliverables while providing input on templates for designated projects.

• Act as the primary negotiator for deliverables and timelines, addressing project-related issues with cross-functional stakeholders.

• Perform literature searches and reviews, including the development of search strategies, management of relevant documentation, and preparation of literature summaries.

• Represent the team in essential meetings concerning reporting plans and regulatory submissions for clinical studies in the US, EU, and globally.

• Lead and contribute to intricate cross-functional deliverables, such as risk management reviews, Instructions for Use (IFUs), and Summary of Safety and Effectiveness Data (SSEDs).

• Offer leadership, training, guidance, and mentoring to junior medical writers.

• Identify, suggest, and aid in implementing ongoing improvements to medical writing processes.

• Serve as the primary point of contact for medical writing projects and manage timelines for internal and external deliverables in collaboration with Edwards departments and clients.

⛳️ Requirements

• Bachelor's Degree in a related field with 5 years of relevant experience in medical writing or equivalent work experience according to Edwards standards.

• Proficient in developing clinical evaluation reports (CERs) in accordance with MEDDEV 2.7/1 REV. 4 and/or the European Union Medical Device Regulation (EU MDR).

• Demonstrated proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.

• Familiarity with publication library software (e.g., ENDNOTE) and database systems (e.g., PubMed).

• Exceptional written and verbal communication skills, along with strong customer negotiation and relationship management abilities.

• Strong problem-solving, organizational, analytical, and critical thinking skills.

• Comprehensive knowledge and understanding of policies, procedures, and guidelines related to the creation of scientific content and medical writing.

• Effective leadership skills with the capability to influence change.

• High attention to detail.

• Ability to engage professionally with all levels within the organization.

• Capacity to manage competing priorities in a dynamic environment.

• Capability to collaborate within a team setting, including inter-departmental teams and key contacts representing the organization on projects.

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

• A diverse range of benefits programs tailored to meet the unique needs of employees and their families.