Senior Medical Writer - Clinical Documentation

Placements24; Roanoke (VA); Hybrid; USD 54,000 - 72,000; Full time

Benefits offered by this job

Competitive salary and benefits

Professional development opportunities

Hybrid work environment

Job summary

Our client, a prominent pharmaceutical research organization, seeks a Senior Medical Writer to join their team in East London, Eastern Cape. The role focuses on authoring regulatory and clinical documents ensuring compliance with ICH, FDA, EMA, and SAHPRA guidelines.

A hybrid work model is offered to support collaboration and timely delivery of high-quality documents. The ideal candidate holds a Life Sciences degree, 5+ years of medical writing experience in pharma/biotech, and strong

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field.
• A Master's or PhD is advantageous.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• In-depth knowledge of clinical trial processes and regulatory requirements for drug development.
• Proficiency in interpreting clinical data, statistical outputs, and regulatory guidelines.
• Exceptional written and verbal communication skills, with a keen eye for detail and grammatical accuracy.
• Strong organizational and project management skills, with the ability to manage multiple projects and deadlines.
• Ability to work independently and as part of a collaborative team in a Hybrid environment.
• Proficiency in Microsoft Office Suite, particularly Word, and familiarity with document management systems.
• Understanding of Good Clinical Practice (GCP) principles.
• Experience in specific therapeutic areas is a plus.

Responsibilities

• Author, edit, and review regulatory and clinical documents, including CTDs, IBs, CSRs, and SOPs.
• Ensure documents are scientifically accurate, clear, concise, and compliant with regulatory guidelines (ICH, FDA, EMA, SAHPRA).
• Collaborate with cross-functional teams to gather information and ensure accuracy of documentation.
• Manage document timelines and deliverables, proactively identifying and mitigating risks.
• Maintain understanding of therapeutic areas and protocols documented.
• Contribute to the development and maintenance of document templates and style guides.
• Review and provide input on documents authored by junior writers or external vendors.
• Stay updated on evolving regulatory requirements and industry best practices for medical writing.
• Ensure consistency in messaging and data presentation across related documents.
• Participate in internal and external meetings related to documentation development.

Skills

Regulatory writing

Clinical data interpretation

Documentation planning

Communication skills

Project management

Team collaboration

Education

Bachelor's in Life Sciences

Master's degree preferred

PhD advantageous

Tools

Microsoft Word

Document management systems

Job description

About the Role

Our client, a prominent pharmaceutical research organization, is seeking a meticulous and experienced Senior Medical Writer to contribute to their growing team in East London, Eastern Cape . This role is vital in ensuring clear, accurate, and compliant communication of clinical trial data and research findings. The Senior Medical Writer will be responsible for authoring a variety of essential regulatory and clinical documents, adhering to strict guidelines and timelines. This position offers a challenging yet rewarding career opportunity for individuals passionate about scientific communication within the pharmaceutical industry. The role operates under a Hybrid work model, allowing for flexibility while ensuring essential team collaboration.

Key Responsibilities

• Author, edit, and review a wide range of clinical and regulatory documents, including clinical study protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and Common Technical Document (CTD) modules.
• Ensure all documents are scientifically accurate, clear, concise, and compliant with relevant regulatory guidelines (e.g., ICH, FDA, EMA, SAHPRA).
• Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and medical affairs, to gather information and ensure the accuracy of documentation.
• Manage document timelines and deliverables, proactively identifying and mitigating potential risks.
• Maintain a thorough understanding of therapeutic areas and the specific protocols being documented.
• Contribute to the development and maintenance of document templates and style guides.
• Review and provide input on documents authored by junior writers or external vendors.
• Stay updated on evolving regulatory requirements and industry best practices for medical writing.
• Ensure consistency in messaging and data presentation across all related documents.
• Participate in internal and external meetings related to documentation development.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field.
• A Master's or PhD is advantageous.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry, with a strong track record of authoring complex clinical documents.
• In-depth knowledge of clinical trial processes and regulatory requirements for drug development.
• Proficiency in interpreting clinical data, statistical outputs, and regulatory guidelines.
• Exceptional written and verbal communication skills, with a keen eye for detail and grammatical accuracy.
• Strong organizational and project management skills, with the ability to manage multiple projects and deadlines.
• Ability to work independently and as part of a collaborative team in a Hybrid environment.
• Proficiency in Microsoft Office Suite, particularly Word, and familiarity with document management systems.
• Understanding of Good Clinical Practice (GCP) principles.
• Experience in specific therapeutic areas is a plus.

Benefits

• Our client offers a competitive salary package, comprehensive medical and dental insurance, a retirement savings plan, and generous paid time off.
• We are committed to professional development, providing access to training programs, workshops, and opportunities to attend relevant industry conferences.
• The hybrid work environment supports a good work-life balance.