Senior Medical Writer (Project Mgt exp)

We are seeking a Senior Medical Writer with a strong background in project management to lead and mentor a team. This role requires a professional who can independently manage medical writing activities for individual studies, ensuring projects are completed on time and on budget. The ideal candidate will be a leader who can effectively coordinate with various departments and stakeholders, while also maintaining high standards for documentation and compliance.

Roles & Responsibilities

• Project & Team Leadership:
• Serve as a project lead for assigned writing projects, with overall accountability for deliverables.
• Manage medical writing activities across and within departments with minimal supervision.
• Mentor and lead less-experienced medical writers on complex projects.
• Manage and handle a team effectively, providing guidance and oversight.
• Content Creation & Compliance:
• Compile, write, and edit medical writing deliverables, including operating guidance documents, SOPs, and training guides.
• Create process maps from provided technical material or client inputs, with hands-on experience using MS Visio or similar tools.
• Adhere to established regulatory standards, company SOPs, and client templates.
• Collaboration & Quality Assurance:
• Act as a peer reviewer for the internal team, providing feedback on draft and final documents.
• Review statistical analysis plans and table/figure/listing specifications for appropriate content and consistency.
• Interact with staff in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Problem-Solving & Administration:
• Identify and propose solutions to resolve issues and questions that arise during the writing process.
• Maintain familiarity with current industry practices and regulatory requirements.
• Stay aware of budget specifications for assigned projects and communicate changes to leadership.
• Complete required administrative tasks within specified timeframes.

Skills & Qualifications

• Project management experience is a must.
• Excellent communication skills and proficiency in Microsoft Office.
• Prior team handling experience.
• Ability to create process maps and use tools like MS Visio.
• Strong knowledge of industry practices and regulatory guidelines.
• Proven ability to manage multiple projects and stakeholders effectively.