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Medical Writing Associate Director

Role overview

Qualifications

  • Life-science degree
  • At least eight years of medical writing experience
  • Three years of line management experience
  • Deep knowledge of protocols, clinical study reports, and CTDs

Responsibilities

  • Lead the preparation and review of clinical trial and regulatory documents
  • Manage project deliverables, client interactions, timelines, quality, scope, and profitability
  • Supervise and develop team members while maintaining high engagement
  • Collaborate with sales on proposals and build strong cross-departmental relationships

Key facts

Hard skills

Other skills

  • Leadership
  • Multitasking
  • Quality Assurance
  • Team Building
  • Negotiation

About the company

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) logo

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

  • Staffing & Recruiting
  • TPE
  • 11–50
➡️ HERE IS WHAT WE DO We specialize in searching for and recruiting top talent in the Pharmaceutical and Medical Device Industry in Japan (JPAC) and Asia (APAC) via our Japan and Singapore offices. ➡️ HOW DO WE GET THINGS DONE With nearly two decades of recruitment experience in the Pharmaceutical Industry in Japan and Asia, we have the client-relationship expertise, knowledge, persistence, dedication, and diligence to ensure even the most challenging recruitment searches are successful. ➡️ FOR HIRING MANAGERS Through our extensive contacts with the best, brightest, and most well-prepared candidates in the market, combined with the ability to fully understand our clients' needs, we can quickly provide the perfect solution to your requirements. ➡️ FOR JOB SEEKERS We take the time to listen, understand and present opportunities to you when you are ready. ➡️ WHERE HAVE YOU SEEN US Since 2006, Philip has been writing a monthly column for Pharma Japan. He has also been published in Life Science Leader, The Fordyce Letter and Biosimilar Development. ➡️ WHAT OTHERS SAY "Philip has exceptional knowledge of the Japanese Pharmaceutical Industry. Philip is also dedicated to advancing global business leaders’ knowledge and applied skills through his insightful articles. I have found the articles beneficial in both the business environment and as excellent discussion topics as part of the International Management course I teach at the University of Texas. I highly recommend Philip to support a company's efforts to advance their firm with a "Global Mindset" staff and practices". Scott Manning, Lecturer at San Diego State University and former Country Manager of Alcon Japan "Philip is extremely knowledgeable of the Japanese Pharma Industry and his articles are always very intriguing. He is certainly a person that can identify talent and professionals that could grow and add value to the hiring company" Masaki Nakanishi, Director of Business Development at AnGes, Inc.

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Job description

This role leads the preparation and review of clinical trial and regulatory documents as a senior/lead medical writer. It manages project deliverables, client interactions, timelines, quality, scope, and profitability, while supervising and developing team members and maintaining high engagement. The position also collaborates with sales on proposals and builds strong cross-departmental relationships. Candidates should have a life-science degree, at least eight years of medical writing experience with three years of line management, deep knowledge of protocols, clinical study reports and CTDs, the ability to review statistical plans and outputs, integrate and interpret data from multiple sources, and strong leadership, project management, business, and financial skills.

Requirements

Experienced medical writing leader with a life-science degree, over eight years of medical writing and at least three years of line management. Possesses deep expertise in clinical trial documentation, reviewing statistical analysis plans, and integrating data from multiple sources. Brings strong leadership, project management, and multitasking skills, along with sound judgment, negotiation, business acumen, and financial/budget planning capability.





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