Senior MW/PMW, clinical document writing

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

📋 Description

• Lead the precise and accurate execution of medical writing deliverables.

• Oversee medical writing tasks linked to individual studies and synchronize efforts across various departments.

• Facilitate the resolution of client feedback.

• Prepare clinical and regulatory documents, which include protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations.

• Implement ICH E3 guidelines, company protocols, client standards, templates, authorship requirements, and style guides.

• Organize quality and editorial reviews.

• Manage source documentation effectively.

• Lead team document evaluations and serve as a peer reviewer.

• Assess statistical analysis plans and specifications for tables, figures, and listings.

• Collaborate with clients as well as data management, biostatistics, regulatory affairs, and medical affairs teams.

• Conduct online clinical literature searches while adhering to copyright regulations.

• Identify and suggest solutions for issues, escalating them as necessary.

• Provide technical assistance, training, and consultation.

• Contribute to internal materials, presentations, processes, standard practices, and capabilities.

• Mentor and guide less experienced medical writers on complex projects.

• Cultivate expertise in industry-related topics and regulatory requirements impacting medical writing.

• Monitor assigned project budgets and communicate status updates and changes to medical writing leadership.

• Execute administrative tasks and other assigned responsibilities.

⛳️ Requirements

• Demonstrated strong experience in clinical document writing.

• Capability to lead medical writing deliverables with scientific precision and clarity.

• Competence in managing study-related medical writing tasks with minimal supervision.

• Familiarity with ICH E3 guidelines and relevant regulatory standards.

• Ability to adhere to company SOPs, client standards, approved templates, authorship requirements, and style guides.

• Background in coordinating quality and editorial reviews.

• Proficiency in reviewing statistical analysis plans and specifications for tables, figures, and listings.

• Skill in collaborating with clients and cross-functional teams, including data management, biostatistics, regulatory affairs, and medical affairs.

• Ability to perform clinical literature searches while complying with copyright regulations.

• Capability to provide technical support, training, and consultation.

• Proficiency in mentoring and guiding less experienced medical writers.

• Knowledge of industry topics and regulatory requirements relevant to medical writing.

• Ability to work within budgeted hours and communicate project status effectively.

• Limited travel availability may be necessary (less than 25%).

🏝️ 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 company culture.

• Provision of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO).

• Sick leave benefits.