Submit The Documentation Specified Jobs

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Submit Docs Spec roles are booming as companies accelerate digital compliance and adopt AI‑powered submission tools. The shift toward cloud‑based eCTD portals and real‑time audit trails has created a surge in demand for specialists who can navigate evolving regulatory landscapes.

Positions range from Documentation Specialist and Regulatory Affairs Coordinator to Technical Writer and Compliance Analyst. Core duties include drafting and reviewing eCTD dossiers, maintaining ISO 9001 and ISO 13485 documentation in MasterControl or SharePoint, managing audit evidence, and liaising with regulatory agencies via portals such as FDA’s 21 CFR Part 11 or EMA’s portal.

Salary transparency in this niche is critical because it highlights the premium paid for expertise in GxP, data privacy, and audit readiness. Clear pay data empowers professionals to assess the true value of their certifications and seek roles that match their skill level.

Staff AI Product Engineer

Company: Modern Health

Location: USA

Posted Dec 19, 2025

This job description seeks an AI Product Engineer with expertise in AI technologies and full-stack development, emphasizing collaboration, problem-solving, and comprehensive benefits including healthcare and flexible work arrangements.

Production Engineer - Langflow

Company: IBM

Location: Markham, CA

Posted Dec 19, 2025

This job description highlights a role at IBM Software focusing on Kubernetes management, automation, and cloud infrastructure. It emphasizes innovation, career growth, and collaboration with cross-functional teams to deliver impactful solutions. The position requires expertise in container orchestration, monitoring tools, and security practices, while offering opportunities to contribute to global technological advancements.

Talent Acquistion Manager

Company: IBM

Location: Giza, EG

Posted Dec 19, 2025

This text describes IBM's role in driving innovation and collaboration, highlighting a positive work culture and opportunities for career growth. It outlines responsibilities related to talent acquisition and team development in Egypt, emphasizing expertise in recruitment and stakeholder management.

Engineering Lead - Test

Company: ScienceLogic

Location: USA

Posted Dec 19, 2025

The QA Lead role involves leading test automation for an AI product, managing a distributed team, and ensuring quality standards. The position offers benefits like flexible time off, comprehensive healthcare, and a supportive work environment.

Lead Medical Writer Medical Communications

Company: Avalere Health

Location: Remote

Posted Dec 19, 2025

Avalere Health emphasizes its mission to serve every patient through inclusive culture, flexible work arrangements, and employee empowerment. The role highlights leadership in medical writing, client collaboration, and professional growth opportunities, alongside comprehensive benefits like flexible working and family support policies.

Oracle AMS PM

Company: IBM

Location: Tokyo, JP

Posted Dec 19, 2025

The role involves managing Oracle Cloud ERPHCM projects, supporting clients, and collaborating with teams. Requires 5+ years of Oracle EBS/ERP Cloud HCM experience. Emphasizes career growth, innovation, and cross-functional teamwork in a dynamic environment.

Senior Product Manager - AI Agents

Company: Apollo.io

Location: USA

Posted Dec 19, 2025

The text describes a senior AI product manager role at Apollo, emphasizing the impact of AI on sales teams, the company's growth metrics, and the responsibilities involving AI research, messaging, and quality assurance. It highlights the importance of trust in AI adoption and the need for domain expertise over technical complexity.

Talent Acquisition Coordinator

Company: IBM

Location: BANGALORE, IN

Posted Dec 19, 2025

This text describes a role at IBM's Talent Acquisition team focusing on managing the offer process with emphasis on collaboration, communication, and career growth. It highlights the importance of teamwork, innovation, and organizational skills in a fast-paced environment while showcasing IBM's commitment to excellence and global impact.

Senior Technical Sourcer

Company: Hightouch

Location: USA

Posted Dec 19, 2025

This job posting highlights a Technical Sourcer role with high visibility, significant impact, and a competitive salary range of $130,000-$180,000 USD. It emphasizes opportunities for growth, equity compensation, and data-driven approaches to sourcing candidates.

Application Developer - Cloud FullStack - New South Wales - 17 Months FTH

Company: IBM

Location: SYDNEY, AU

Posted Dec 19, 2025

IBM is a leader in global transformation, offering career opportunities in tech innovation. The role involves developing applications and collaborating with teams to drive digital reinvention and competitive advantage.

Sr. Marketer - Growth

Company: Blackbaud

Location: Remote

Posted Dec 19, 2025

This job posting seeks a Sr Growth Marketer to lead growth marketing efforts for nonprofit fundraising, focusing on innovative programs, data-driven strategies, and cross-functional collaboration. The role emphasizes generating qualified pipeline, analyzing market trends, and working in a remote-first environment with competitive compensation and benefits.

Software Engineer

Company: Field Nation

Location: Dhaka

Posted Dec 19, 2025

This job posting highlights Field Nation's commitment to a dynamic work environment, competitive benefits, and professional growth opportunities. The role involves developing cutting-edge SaaS solutions and collaborating with cross-functional teams, while the company emphasizes a supportive culture with perks like gym memberships, medical insurance, and flexible work arrangements.

Frequently Asked Questions

What are typical salary ranges by seniority in Submit Docs Spec roles?
Entry‑level Documentation Specialists earn $55,000–$70,000 annually. Mid‑level Coordinators and Technical Writers command $75,000–$95,000, while senior Regulatory Affairs Managers and Compliance Directors often reach $110,000–$140,000, depending on industry and geographic location.
Which skills and certifications are required?
Key skills include eCTD submission, ISO 9001/13485 documentation, GxP audit readiness, MasterControl or Sparta compliance software, and strong technical writing. Certifications such as Certified Regulatory Affairs Professional (CRA), Certified Quality Auditor (CQA), ISO 9001 Lead Auditor, and Six Sigma Green/Black Belt give candidates a competitive edge.
Is remote work available for Submit Docs Spec positions?
Yes, many employers support fully remote or hybrid models for documentation specialists and regulatory coordinators. Remote roles often rely on secure cloud platforms (e.g., SharePoint, Confluence, MasterControl) and virtual audit tools to maintain compliance.
What career progression paths exist?
Typical progression starts with Documentation Specialist → Regulatory Affairs Coordinator → Technical Writer → Regulatory Affairs Manager → Director of Compliance or Regulatory Affairs. Advancement often requires additional certifications and proven success managing multi‑regulatory submissions.
What are current industry trends affecting Submit Docs Spec roles?
Trends include AI‑driven document review for faster submission cycles, blockchain for immutable audit trails, regulatory sandboxes for digital health and medical devices, and increased focus on data privacy regulations like GDPR and CCPA. Professionals who stay current with these technologies will command higher salaries.

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