Medical Writer – Scientific and Regulatory Documents

MNC JOBS INFO; Singapore; Hybrid; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Remote or hybrid working options

Professional development opportunities

Competitive compensation

Insurance and employment entitlements

Job summary

MNC JOBS INFO is seeking a detail-oriented Medical Writer – Scientific and Regulatory Documents to produce and maintain high-quality clinical and regulatory documentation for healthcare professionals, researchers, and authorities.

The role involves translating complex clinical data into clear, accurate content, ensuring regulatory compliance, and collaborating with clinical teams, statisticians, and QA across the study lifecycle.

Qualifications

• Bachelor’s degree or higher in Life Sciences or related field.
• Masters/PharmD/PhD may be preferred for certain positions.
• Certification/training in medical writing or regulatory affairs is valuable.
• Understanding of ICH‑GCP and clinical documentation is desirable.

Responsibilities

• Prepare, draft, review, and edit scientific, medical, and regulatory documents.
• Develop protocols, reports, brochures, informed consent forms, and regulatory submissions.
• Write scientific summaries and literature reviews with evidence-based content.
• Ensure accuracy and consistency with data, sources, and templates.
• Maintain version control and document traceability throughout studies.

Skills

Excellent written English

Scientific terminology

Document structuring/editing

Templates and style guides

Reference management

Reviewer feedback incorporation

Education

Bachelor's degree in Life Sciences or related

Master's degree / PharmD / PhD preferred

Medical writing/regulatory training advantageous

ICH‑GCP familiarity desirable

Tools

Microsoft Word

Excel

PowerPoint

EndNote / Zotero / Mendeley

Job description

1. Job Summary

MNC JOBS INFO is seeking a detail-oriented, scientifically minded, and highly organized Medical Writer – Scientific and Regulatory Documents to support the preparation, development, review, and maintenance of high-quality scientific and regulatory documentation. The successful candidate will translate complex medical, clinical, and scientific information into clear, accurate, consistent, and well-structured documents for healthcare professionals, researchers, regulatory authorities, and other relevant stakeholders.

This role involves working with clinical research teams, medical professionals, biostatisticians, regulatory affairs specialists, pharmacovigilance professionals, and quality assurance teams to develop documentation that meets applicable regulatory expectations, scientific standards, and organizational requirements.

The ideal candidate will have excellent scientific writing abilities, a strong understanding of medical terminology, and the ability to interpret clinical data and research findings accurately. Responsibilities may include preparing clinical study reports, clinical study protocols, informed consent documents, investigator brochures, scientific summaries, regulatory submission materials, manuscripts, literature reviews, and other medical communication documents.

The Medical Writer will also contribute to document quality through evidence verification, reference management, editorial review, consistency checks, and compliance with established writing standards. Candidates who demonstrate scientific curiosity, strong analytical thinking, attention to detail, and a commitment to ethical scientific communication are encouraged to apply.

2. Key Responsibilities

Scientific and Regulatory Document Development

• Prepare, draft, review, and edit scientific, medical, and regulatory documents in accordance with approved templates, project requirements, and applicable guidelines.
• Develop clinical study protocols, clinical study reports, investigator brochures, informed consent forms, and supporting clinical documentation as assigned.
• Assist with the preparation of regulatory submission documents for relevant health authorities.
• Write scientific summaries, clinical evidence reports, medical information documents, and research-based technical content.
• Support the preparation of clinical trial documentation throughout the study lifecycle, from study planning to final reporting.
• Convert complex clinical findings, statistical results, and scientific evidence into clear and understandable written content.
• Ensure that all documents accurately reflect the available clinical data, research findings, and approved source materials.

Clinical Research and Data Interpretation

• Review clinical study data, statistical tables, figures, listings, and other study outputs to ensure accurate representation in written reports.
• Collaborate with clinical operations, data management, biostatistics, and medical teams to clarify study findings and resolve documentation questions.
• Interpret scientific literature, clinical evidence, and research outcomes to support evidence-based document development.
• Verify that conclusions and interpretations are supported by the available data and are not misleading or overstated.
• Identify inconsistencies between source information, tables, figures, and narrative sections and coordinate appropriate corrections.

Regulatory Compliance and Quality Assurance

• Follow applicable regulatory requirements, organizational procedures, and recognized medical writing standards.
• Support the preparation of documentation aligned with relevant International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and applicable regional regulatory expectations.
• Maintain consistency in terminology, formatting, abbreviations, references, tables, figures, and document structure.
• Conduct quality control reviews to identify factual inaccuracies, missing information, grammatical errors, and inconsistencies.
• Incorporate feedback from medical reviewers, regulatory specialists, subject matter experts, and quality assurance personnel.
• Maintain appropriate version control, document traceability, review records, and approval documentation.
• Handle confidential clinical trial information and sensitive research data responsibly.

Literature Research and Reference Management

• Conduct structured literature searches using reliable scientific databases and approved research resources.
• Review published studies, clinical guidelines, peer-reviewed journals, and other credible scientific sources.
• Evaluate the relevance and quality of scientific evidence before incorporating findings into documents.
• Maintain accurate citations, bibliographies, and reference lists using approved reference management tools.
• Verify that cited information supports the statements and conclusions presented in the document.
• Avoid plagiarism and ensure compliance with applicable publication ethics and scientific integrity standards.

Cross-Functional Collaboration

• Work closely with clinical research associates, clinical scientists, medical monitors, biostatisticians, regulatory affairs teams, and other stakeholders.
• Participate in document planning meetings, review discussions, and project status updates.
• Clarify scientific questions and obtain missing information from appropriate subject matter experts.
• Coordinate document reviews and revisions to meet agreed project timelines.
• Communicate project progress, potential risks, and documentation challenges to relevant team members.
• Contribute to the continuous improvement of writing templates, standard operating procedures, and document development workflows.

Documentation Management and Continuous Improvement

• Maintain organized records of drafts, revisions, approvals, and supporting source materials.
• Manage multiple writing assignments while prioritizing tasks according to deadlines and project requirements.
• Stay informed about changes in medical writing practices, clinical research standards, regulatory expectations, and scientific communication.
• Identify opportunities to improve document clarity, efficiency, consistency, and quality.
• Participate in relevant training sessions and professional development activities.

3. Required Skills and Qualifications

Educational Qualifications

• A bachelors degree or higher in a relevant discipline, such as Life Sciences, Pharmacy, Medicine, Biotechnology, Biochemistry, Nursing, Biomedical Sciences, or a related scientific field.
• A masters degree, PharmD, PhD, MBBS, or another relevant advanced qualification may be preferred for certain positions.
• A certification or formal training in medical writing, clinical research, regulatory affairs, or scientific communication is an advantage.
• Relevant professional training in ICH‑GCP and clinical research documentation is desirable.

Technical Writing Skills

• Excellent written English, including grammar, spelling, punctuation, and scientific terminology.
• Ability to communicate complex scientific concepts clearly, accurately, and logically.
• Strong skills in document structuring, editing, proofreading, and scientific narrative development.
• Ability to follow document templates, style guides, and terminology conventions.
• Familiarity with scientific referencing styles and reference management software.
• Ability to incorporate reviewer feedback while preserving scientific accuracy and consistency.

Scientific and Clinical Knowledge

• Understanding of clinical research principles, clinical trial design, and study documentation.
• Familiarity with clinical endpoints, safety reporting, efficacy assessments, and statistical terminology.
• Basic understanding of clinical data interpretation and evidence-based scientific communication.
• Awareness of research ethics, patient confidentiality, and responsible publication practices.
• Familiarity with regulatory documentation requirements and clinical research terminology.

Software and Digital Skills

• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to use document formatting tools, tracked changes, comments, and collaborative review features.
• Familiarity with scientific databases such as PubMed and other relevant literature research platforms.
• Experience with reference management tools such as EndNote, Zotero, or Mendeley is beneficial.
• Knowledge of document management systems, electronic document workflows, and clinical trial management systems is an advantage.
• Familiarity with clinical data visualization, statistical tables, and document quality control tools is desirable.

4. Experience

• The experience requirements will depend on the level of the position and the complexity of the assigned projects.
• Entry‑Level Candidates: Recent graduates with a relevant scientific degree, strong writing skills, and a demonstrated interest in medical writing may be considered for junior or trainee opportunities, where available. Academic research projects, dissertations, literature reviews, and scientific presentations can demonstrate relevant capabilities.
• Early‑Career Candidates: Approximately 1–3 years of experience in medical writing, clinical research, scientific communication, regulatory documentation, or a related role is advantageous.
• Experienced Candidates: Approximately 3–5 years or more of relevant experience may be preferred for positions involving independent document ownership, complex clinical study reports, regulatory submissions, or coordination with multiple stakeholders.
• Candidates with experience preparing clinical study reports, clinical protocols, investigator brochures, regulatory submission documents, or scientific manuscripts will have an advantage.
• Experience in pharmaceutical companies, biotechnology organizations, contract research organizations (CROs), medical communications agencies, or academic research institutions is desirable.
• Applicants should be able to demonstrate their ability to produce accurate, evidence-based documents, manage competing deadlines, and maintain high standards of scientific integrity.

5. Working Hours

Employment Schedule: Full-time or part-time, depending on the approved position.

Typical Full-Time Hours: Approximately 8 hours per day, 5 days per week, subject to the employers working schedule.

Working Days: Monday to Friday for standard office-based assignments, with variations depending on project requirements.

Work Arrangement: Remote, hybrid, or on‑site arrangements may be available depending on the specific vacancy.

Flexible Scheduling: Some flexibility may be possible when project deadlines, team coordination, and review meetings permit.

Project Deadlines: Employees must be able to organize their workload effectively and deliver documents within agreed timelines.

Meetings and Collaboration: Occasional meetings with international teams may require schedule adjustments across time zones.

The final working schedule, employment terms, and work location will be communicated during the recruitment process. No specific remote arrangement or flexible schedule is guaranteed unless confirmed in the formal job offer.

6. Knowledge, Skills, and Abilities

Scientific Knowledge

• Understanding of scientific research methods and evidence-based writing.
• Knowledge of clinical trial terminology, clinical study processes, and medical documentation.
• Awareness of applicable regulatory guidance and scientific publication standards.
• Ability to distinguish between established evidence, study limitations, and interpretations requiring further validation.

Analytical and Critical‑Thinking Skills

• Ability to analyze complex scientific information and identify inconsistencies.
• Strong attention to detail when reviewing data, references, and supporting documents.
• Ability to assess whether conclusions are appropriately supported by available evidence.
• Skill in identifying missing information, unclear statements, and potential documentation risks.

Communication and Collaboration

• Excellent written communication and professional interpersonal skills.
• Ability to communicate scientific questions clearly to subject matter experts.
• Confidence in participating in document review meetings and incorporating constructive feedback.
• Ability to work collaboratively with multidisciplinary and geographically distributed teams.

Organizational Abilities

• Strong time‑management, planning, and prioritization skills.
• Ability to manage multiple documents and review cycles simultaneously.
• Commitment to meeting deadlines without compromising scientific quality.
• Ability to maintain accurate records and follow established document control procedures.

Professional Ethics and Accountability

• Commitment to scientific accuracy, transparency, and research integrity.
• Respect for patient privacy, confidential information, and applicable data protection requirements.
• Understanding of plagiarism prevention and responsible use of scientific references.
• Willingness to acknowledge limitations in the available evidence and elevate unresolved scientific questions.
• Professional attitude, adaptability, reliability, and willingness to learn.

7. Benefits

• Competitive compensation aligned with qualifications, experience, and role responsibilities.
• Opportunities to work on scientific documentation and clinical research projects.
• Access to relevant medical writing, regulatory affairs, and clinical research training.
• Professional development opportunities to strengthen scientific communication and technical writing capabilities.
• Exposure to multidisciplinary teams and industry‑standard documentation practices.
• Opportunities to develop expertise in clinical study reports, regulatory submissions, and scientific publications.
• Potential remote or hybrid working options for eligible positions.
• Collaborative work environments that encourage knowledge sharing and continuous learning.
• Performance feedback and opportunities to expand responsibilities as skills develop.
• Potential career advancement into senior medical writing, regulatory writing, medical communications, or clinical documentation leadership roles.
• Benefits, compensation, paid leave, insurance, and other employment entitlements will depend on the actual vacancy, employment contract, and applicable company policies. Applicants should confirm the available benefits with the recruitment team.

8. Why Join MNC JOBS INFO?

Joining MNC JOBS INFO for a Medical Writer – Scientific and Regulatory Documents opportunity may be suitable for professionals who want to build a career at the intersection of science, clinical research, and technical communication.

This role offers the opportunity to apply scientific knowledge to meaningful documentation that supports the communication of clinical research findings and the preparation of accurate regulatory materials. Medical writers play an important role in ensuring that complex scientific information is communicated clearly, consistently, and responsibly.

Successful candidates can strengthen their scientific writing abilities, develop a deeper understanding of clinical research documentation, and gain experience collaborating with professionals from different scientific and regulatory disciplines.

The position may also provide a foundation for career growth in medical writing, regulatory affairs, clinical research, scientific publications, medical communications, and related fields.

MNC JOBS INFO aims to present this opportunity to candidates who value accuracy, professionalism, continuous learning, and evidence-based communication. Applicants are encouraged to verify the specific employer, role availability, work arrangement, compensation, and employment conditions before accepting an offer.