Offer summary

Qualifications:

At least 4 - 8 years of experience in Regulatory publishing., Bachelor’s or Master’s degree in Pharmacy, Pharma, Medical, or a related scientific discipline., Expertise with industry-standard electronic document management systems., Experience in project management and leading teams..

Key responsabilities:

Collaborate with submission managers to oversee the production of high-quality submission assemblies.

Ensure submission assemblies comply with internal and external electronic submission standards.

Lead and mentor internal and external publishing staff through training and guidance.

Track and report departmental metrics, including project status and publishing discrepancies.

➡️ 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.

Job description

Collaborate with submission managers to oversee the production of high-quality submission assemblies (eCTD, NeeS, Paper) using submission-ready documents that comply with internal and external electronic submission standards.
Ensure that submission assemblies maintain the required technical integrity to pass health authority validation checks.
Lead and mentor both internal and external publishing staff through training and guidance.
Support submission project teams by identifying submission-ready content requirements and ensuring adherence to timeline milestones for error-free submission assemblies.
Proactively identify, evaluate, and address potential risks or issues that may affect the successful completion of regulatory submissions, escalating when necessary.
Track and report departmental metrics, including project status, daily production activities, and publishing discrepancies.
Administrative Support
Take the lead in developing and maintaining publishing processes and documentation, including conducting user acceptance testing for new or updated publishing tools, and delegate related tasks to team members as needed.
Serve as a subject matter expert (SME) for specific functions or processes, providing mentorship within the department and liaising with external stakeholders.
Assess current activities and business processes to identify areas for improvement and lead initiatives to explore potential solutions or alternative approaches.

Requirements

Skills Required:

At least 4 - 8 years of experience in Regulatory publishing.
Bachelor’s / Master’s in Pharmacy / Pharma / Medical or other associated scientific discipline
Expertise with industry standard electronic document management system
Experience with project management and leading teams