Principal/Senior Medical Editor – Publications Documents

This is a fully remote position, open to applicants in United States, +1 more state.

📋 Description

• Maintain an understanding of FDA, EU, and other pertinent guidelines and industry standards to ensure that documents align with sponsor and regulatory expectations.

• Act as a representative of the editorial team in medical writing, study teams, and cross-functional project groups.

• Oversee timelines and budgets for assigned projects, escalating risks related to deliverables as necessary.

• Offer technical support and expertise.

• Conduct training sessions and mentor staff involved in medical editing.

• Provide guidance to medical writers, medical editors, and study teams regarding quality review, compilation, and editorial standards.

• Train members of the global medical writing team.

• Lead the creation of deliverables for intricate and/or large-scale medical writing projects.

• Organize and facilitate internal project-specific team meetings.

• Structure project requirements and ensure that information is communicated to and acted upon by the editorial team.

• Participate as a medical writing team member for projects that require medical writing deliverables.

• Offer constructive feedback to the lead medical writer regarding editorial progress.

• Edit assigned documents for grammar, punctuation, spelling, style, adherence to the AMA Manual of Style, custom style guidelines, checklists, and best practices.

• Conduct quality reviews of assigned documents to ensure accuracy.

• Contribute to the development of process improvement tools and internal policies and procedures.

• Manage assigned projects in accordance with medical writing SOPs and client standards, ensuring timely and budget-compliant delivery.

• Compile medical writing deliverables as necessary.

⛳️ Requirements

• Strong knowledge of FDA, EU, and other relevant guidelines and industry standards.

• Capability to ensure that documents meet or surpass sponsor and regulatory requirements.

• Expertise in medical editing, including copyediting and quality review.

• Familiarity with grammar, punctuation, spelling, and style conventions.

• Proficient in the AMA Manual of Style and custom style guidelines.

• Knowledge of medical writing internal checklists and best practices.

• Ability to lead complex and/or large medical writing projects.

• Competence in monitoring project timelines and budgets.

• Capability to provide technical support and training.

• Ability to mentor medical editing staff and advise medical writers, medical editors, and study teams.

• Experience in managing projects according to medical writing standard operating procedures and client standards.

• Equivalent experience, skills, and/or education may be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Company vehicle or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions or bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick leave provisions.

• Reasonable accommodations provided when appropriate.