Regulatory Writer (Content Manager with eCOA experience)

One CoreDev IT Inc.; Manila; On-site; PHP 446,400 - 781,200; Full time

Benefits offered by this job

13th Month Pay

Paid Holidays

HMO Health & Wellness

Company Social Events

Job summary

One CoreDev IT Inc. in Manila is seeking a Regulatory Writer (Content Manager) with eCOA experience to oversee end-to-end content management for clinical trials. You will translate, adapt, and publish content across platforms while ensuring regulatory alignment and quality.

You will collaborate with project managers, developers, and clients to tailor content to study requirements, maintain version control, and drive process improvements in a fast-paced health-tech environment.

Qualifications

• 3 years of experience in content management within regulated industries such as life sciences, pharmaceuticals, or clinical trials.
• Amenable to work onsite, mid shift/night shift or shifting schedules.
• Hands-on experience with Electronic Clinical Outcome Assessment (eCOA) systems and Content Management Systems (CMS).
• Understanding of clinical trial processes, particularly document and data collection.
• Familiarity with life sciences compliance, including regulations such as GxP, 21 CFR Part 11, or other relevant standards.
• Excellent interpersonal and communication skills, with the ability to engage with both technical and non-technical stakeholders.
• Proven ability to manage content across teams and adapt to changing requirements.
• High attention to detail, with a strong focus on quality and compliance.
• Effective problem-solving skills with the ability to manage multiple priorities and deadlines in a fast-paced environment.

Responsibilities

• Content Strategy & Management: Oversee the end-to-end content management process for clinical trials, including content adaptation, translation, and version control, ensuring alignment with client needs and regulatory requirements.
• Collaboration with Project Managers: Work directly with project managers to ensure content aligns with the timelines and objectives of clinical trial platform adaptations, ensuring seamless integration with existing systems.
• Cross-functional Collaboration: Partner with internal development team and external clients to ensure content fits within the platform's parameters and addresses study-specific requirements during implementation.
• Quality Assurance & Compliance: Ensure all content is accurate, consistent, and compliant with life sciences regulations, managing updates and revisions as needed.
• Content Maintenance & Support: Proactively manage content-related requests, updates, and bug fixes, providing support to clinical teams throughout the study lifecycle.
• Process Improvement: Drive initiatives to enhance content management practices, leveraging feedback and lessons learned from past studies to optimize workflows and project outcomes.
• Client & Stakeholder Engagement: Maintain clear and consistent communication with internal teams and clients, ensuring content management activities are aligned with broader project goals.

Skills

Content management

Regulatory compliance

Cross-functional collaboration

Attention to detail

Stakeholder engagement

Education

Bachelor's degree

Tools

CMS

eCOA systems

Job description

Regulatory Writer (Content Manager with eCOA experience)

On-site - Manila 3-5 Yrs Exp Bachelor Full-time

Job Description

Government Mandated Benefits

13th Month Pay, Paid Holidays

Insurance Health & Wellness

HMO

Others

Company Social Events

As a Regulatory Writer (Content Manager), you will play a key role in managing content across the implementation and adaptation stages of our digital health solutions. You'll collaborate with cross-functional teams, ensuring that content is effectively processed, translated, and published, while adhering to industry standards and supporting the ongoing improvement of our digital products for clinical trials.

The Content Manager reports to Technical Project Management Team Lead, Life Sciences.

What you'll do:

• Content Strategy & Management: Oversee the end-to-end content management process for clinical trials, including content adaptation, translation, and version control, ensuring alignment with client needs and regulatory requirements.
• Collaboration with Project Managers: Work directly with project managers to ensure content aligns with the timelines and objectives of clinical trial platform adaptations, ensuring seamless integration with existing systems.
• Cross-functional Collaboration: Partner with internal development team and external clients to ensure content fits within the platform's parameters and addresses study-specific requirements during implementation.
• Quality Assurance & Compliance: Ensure all content is accurate, consistent, and compliant with life sciences regulations, managing updates and revisions as needed.
• Content Maintenance & Support: Proactively manage content-related requests, updates, and bug fixes, providing support to clinical teams throughout the study lifecycle.
• Process Improvement: Drive initiatives to enhance content management practices, leveraging feedback and lessons learned from past studies to optimize workflows and project outcomes.
• Client & Stakeholder Engagement: Maintain clear and consistent communication with internal teams and clients, ensuring content management activities are aligned with broader project goals.
• Other duties and responsibilities as required.

Who you are:

• 3 years of experience in content management within regulated industries such as life sciences, pharmaceuticals, or clinical trials.
• Amenable to work onsite, mid shift/night shift or shifting schedules.
• Hands-on experience with Electronic Clinical Outcome Assessment (eCOA) systems and Content Management Systems (CMS).
• Understanding of clinical trial processes, particularly document and data collection.
• Familiarity with life sciences compliance, including regulations such as GxP, 21 CFR Part 11, or other relevant standards.
• Excellent interpersonal and communication skills, with the ability to engage with both technical and non-technical stakeholders.
• Proven ability to manage content across teams and adapt to changing requirements.
• High attention to detail, with a strong focus on quality and compliance.
• Effective problem-solving skills with the ability to manage multiple priorities and deadlines in a fast-paced environment.

Working Location

16th Floor, The Peak Tower, Salcedo Village,, 107 L.P. Leviste Street, Makati, 1227 Metro Manila, Philippines