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.

Senior Product Manager E Commerce

Company: Ollie

Location: Remote

Posted Dec 09, 2025

Ollie focuses on improving pets' lives through premium pet food and services. They offer a Senior Product Manager role with competitive benefits, emphasizing teamwork and innovation. The company values dogs, courage, and continuous improvement.

Senior Solution Architect - IBM Z Ecosystem

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

This text describes a job posting for a Senior Solution Architect role at IBM Z Ecosystem, emphasizing expertise in IBM Z Mainframe technologies, hybrid cloud, AI, DevOps, and collaboration with business partners to modernize enterprise applications. It outlines technical requirements, preferred qualifications, and responsibilities involving architectural design, client engagement, and technology adoption.

HubSpot Careers All Openings

Company: HubSpot

Location: Cambridge

Posted Dec 09, 2025

The text promotes job openings at HubSpot with application instructions, including specific tags for verification and mentions a beta feature to filter spam applicants.

Internship: SAP Consultant in Guadalajara, Mexico

Company: IBM

Location: GUADALAJARA, MX

Posted Dec 09, 2025

The text promotes an IBM Consulting internship program offering career growth, technical training, and opportunities to work with global clients. It highlights benefits like skill development, industry expertise, and collaboration with innovative companies, while outlining requirements such as academic performance, SAP knowledge, and language proficiency.

SAP Enterprise Service Management (ESM) Package Consultant

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This job description highlights a career in IBM Consulting focused on SAP ESM solutions, emphasizing collaboration with clients, technical expertise, and career growth opportunities. It outlines requirements for experience in SAP implementations, project leadership, and strong communication skills, while promoting a culture of innovation and professional development.

Benefits Analyst

Company: Bennie

Location: Remote

Posted Dec 09, 2025

Bennie is a benefits platform prioritizing employee well-being through technology and services. Core values include optimism, accountability, and work-life balance. The Benefits Analyst role requires Excel skills and a positive attitude.

Legal Technology Consulting Director Discovery and Data Management

Company: Harbor

Location: Remote, United States

Posted Dec 09, 2025

Harbor is hiring a Legal Technology Consulting Director for Discovery and Data Management, seeking candidates with eDiscovery expertise. The remote role offers opportunities to work with Fortune 500 companies and includes a beta feature requiring applicants to mention 'UNPARALLELED' and a specific tag to verify they read the job post.

SAP Enterprise Service Management (ESM) Package Consultant

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This job description outlines a consultant role at IBM requiring SAP ESM expertise, project delivery experience, and collaboration with cross-functional teams. It emphasizes technical skills, client success, and integration of ESM processes with SAP systems.

PeopleSoft HCM Administrator

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

The text describes a Senior PeopleSoft Administrator role at IBM Consulting, emphasizing long-term client relationships, career growth opportunities, and collaboration with industry visionaries. It highlights the importance of technical expertise in PeopleSoft, cloud technologies, and security compliance, while also showcasing a supportive work environment focused on innovation and professional development.

Application Architect – EHS, Quality & PLM Systems

Company: IBM

Location: No City, US

Posted Dec 09, 2025

This job description outlines an Application Architect role at IBM Consulting, focusing on designing and optimizing enterprise systems for regulated environments. The position offers remote work and collaboration with global clients, emphasizing innovation in hybrid cloud and AI solutions.

SAP Consultant (AIF & Interfaces)

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This text describes a senior SAP Consultant role at IBM Consulting, emphasizing collaboration with clients, innovation in hybrid cloud and AI, career growth opportunities, and technical expertise in SAP integration. It highlights the importance of strategic partnerships, technology platforms, and cross-functional teamwork in delivering impactful solutions.

Clinical Operations Specialist Quality & Safety

Company: Midi Health

Location: Remote

Posted Dec 09, 2025

This job posting highlights a Clinical Operations Specialist role focused on improving patient safety and quality through data analysis, workflow improvements, and collaborative team efforts. The position emphasizes meaningful impact, organizational growth, and supportive environments, with key responsibilities in quality improvement and data-driven insights.

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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