Senior Specialist, Medical Writing

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

📋 Description

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

• Oversee the negotiation of deliverables and timelines, addressing project-related challenges with cross-functional stakeholders

• Perform literature searches and reviews, formulate search strategies, manage relevant documentation, and compile literature summaries

• Represent the medical writing department in core team meetings regarding reporting plans and regulatory submissions for clinical trials

• Lead and contribute to complex cross-functional deliverables, which include risk management reviews, IFUs, and SSEDs

• Offer leadership, training, guidance, and mentorship to junior medical writers

• Identify, suggest, and support the implementation of continuous improvements in medical writing processes

⛳️ Requirements

• Bachelor's Degree in a related field with 5 years of relevant experience in medical writing, or equivalent work experience as per Edwards criteria

• A graduate degree in life sciences, engineering, or a related field is preferred

• Experience in developing clinical evaluation reports under MEDDEV 2.7/1 REV. 4 and/or EU MDR is preferred

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

• Familiarity with publication library software such as ENDNOTE and database systems like PubMed

• Exceptional written and verbal communication skills, encompassing customer negotiation and relationship management abilities

• Strong problem-solving, organizational, analytical, and critical thinking capabilities

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

• Effective leadership skills with the ability to influence change

• Meticulous attention to detail

• Proficient in interacting professionally with all levels of the organization

• Capacity to manage competing priorities in a fast-paced setting

• Ability to collaborate within a team environment, including inter-departmental teams and key organizational contacts on projects

🏝️ Benefits

• Competitive salaries

• Performance-based incentives

• A diverse array of benefits programs catering to the varied individual needs of employees and their families