[Remote] Publications Lead

Work set-up: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

4 to 8 years of experience in regulatory publishing., Proficiency in Lorenz docuBridge, Liquent InSight Publisher, and global publishing systems., Strong skills in electronic document management systems., Fluency in English and Japanese..

Key responsibilities:

  • Lead the preparation of regulatory submission packages ensuring compliance.
  • Train and mentor internal teams and external partners.
  • Support content requirements and timeline alignment for submissions.
  • Identify and resolve risks or issues affecting submission completion.

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) logo
Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) Human Resources, Staffing & Recruiting TPE https://www.morunda.com/
11 - 50 Employees
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Job description

  • Collaborate closely with submission managers to lead the preparation of high-quality regulatory submission packages (eCTD, NeeS, or paper), ensuring all documents meet internal standards and regulatory guidelines.
  • Guarantee that submission packages meet the necessary technical standards for validation by health authorities.
  • Take a leadership role in training and mentoring both internal teams and external publishing partners.
  • Support submission teams in defining content requirements and aligning timelines to ensure accurate and timely submissions.
  • Proactively identify and resolve or escalate any risks or issues that may hinder successful submission completion.
  • Monitor project progress, daily publishing tasks, and address any irregularities, contributing to departmental metrics tracking.
  • Provide general administrative support as needed.
  • Lead the creation and maintenance of publishing procedures and documentation, including user acceptance testing for new or updated tools, and delegate tasks as appropriate.
  • Serve as a subject matter expert for specific processes or functions, offering guidance and support to team members and external partners.
  • Analyze workflows and business practices, identify opportunities for improvement, and drive implementation of enhanced processes.

Requirements
  • 4 to 8 years of hands-on experience in regulatory publishing.
  • Proficient in Lorenz docuBridge, Liquent InSight Publisher, and global publishing systems.
  • Skilled in using electronic document management systems commonly used in the industry.
  • Demonstrated experience in project leadership and team coordination.
  • Fluency in both English and Japanese is required.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
EnglishJapanese
Check out the description to know which languages are mandatory.

Other Skills

  • Team Management
  • Collaboration
  • Training And Development
  • Mentorship
  • Problem Solving

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