Senior Medical Writer - Regulatory Documentation

Placements24; Riverton (UT); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Fully remote

Competitive salary

Bonus program

Health insurance

Retirement planning

Paid time off

Job summary

Placements24 seeks a Senior Medical Writer to join a global pharmaceutical leader. This fully remote role supports regulatory documentation from anywhere within the country, contributing to CSRs, IBs, and CTD modules.

You will collaborate with clinical operations, biostatistics, regulatory affairs to ensure content accuracy, alignment with ICH, FDA, EMA, and SAHPRA guidelines, and timely delivery. Applicants should have 6–8 years of regulatory writing experience, an advanced life-science degree,

Qualifications

• Advanced degree (Master's or Ph.D.) in a life science or related field.
• 6–8 years of experience as a Medical Writer in pharma/biotech focusing on regulatory docs.
• Proven ability to author complex regulatory documents for global submissions.
• Strong understanding of ICH guidelines and submission requirements.
• Excellent writing, editing, proofreading, and data interpretation skills.

Responsibilities

• Author, edit, and review CSR, IBs, protocols, and CTD modules.
• Ensure documents comply with ICH, FDA, EMA, SAHPRA guidelines.
• Collaborate with clinical ops, biostatistics, and regulatory affairs to gather content.
• Manage multiple writing projects with timelines.
• Develop and implement departmental templates, style guides, and SOPs.
• Maintain knowledge of therapeutic areas and drug development processes.
• Review documents produced by teammates or external vendors.
• Ensure consistency in messaging and terminology across documents.
• Participate in team meetings and departmental initiatives.
• Stay updated on evolving regulatory requirements and best practices.

Skills

Regulatory writing

Medical writing

Project management

ICH guidelines

Independent work

Education

Master's or Ph.D. in life sciences

Job description

About the Role

Our client, a global leader in pharmaceutical research and development, is seeking a highly skilled Senior Medical Writer to join their expanding team. This position is fully remote, offering flexibility and the opportunity to contribute to critical regulatory documentation from anywhere within South Africa . You will be responsible for preparing clear, concise, and scientifically accurate documents required for regulatory submissions, clinical study reports, and publications. This role demands exceptional writing skills, a deep understanding of pharmaceutical development, and the ability to work collaboratively with cross-functional teams. We are looking for an experienced professional who can manage complex writing projects and ensure compliance with all relevant guidelines and standards, supporting the timely advancement of innovative therapies through the regulatory process.

Key Responsibilities

• Author, edit, and review a variety of regulatory documents, including Clinical Study Reports (CSRs), Investigator's Brochures (IBs), protocols, and Common Technical Document (CTD) modules.
• Ensure all documents are scientifically accurate, clear, concise, and compliant with applicable regulatory guidelines (e.g., ICH, FDA, EMA, SAHPRA).
• Collaborate closely with clinical operations, biostatistics, regulatory affairs, and other subject matter experts to gather information and ensure the accuracy of content.
• Manage multiple writing projects simultaneously, ensuring timely completion and adherence to project timelines.
• Contribute to the development and implementation of departmental templates, style guides, and standard operating procedures (SOPs).
• Maintain a thorough understanding of therapeutic areas, drug development processes, and relevant scientific literature.
• Review and provide feedback on documents authored by other team members or external vendors.
• Ensure consistency in messaging and terminology across all submitted documents.
• Participate in team meetings and contribute to departmental initiatives.
• Stay updated on evolving regulatory requirements and medical writing best practices.

Requirements

• Advanced degree (Master's or Ph.D.) in a life science, health science, or related field.
• A minimum of 6-8 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry, with a strong focus on regulatory documentation.
• Demonstrated expertise in authoring complex regulatory documents for global submissions.
• Thorough understanding of ICH guidelines and regulatory submission requirements.
• Excellent scientific understanding, writing, editing, and proofreading skills.
• Proficiency in data interpretation and presentation.
• Strong project management skills with the ability to manage timelines and priorities effectively.
• Ability to work independently and collaboratively in a fully remote setting.
• Exceptional communication and interpersonal skills.
• Proficiency with document management systems and relevant software is an advantage.

Benefits

• This fully remote position offers significant flexibility and work-life balance.
• Our client provides a highly competitive salary, performance bonuses, and a comprehensive benefits package including health insurance, retirement planning, and paid time off.
• We are committed to employee development through continuous learning opportunities, training programs, and conference attendance.
• You will have the opportunity to work on impactful global projects and contribute to the success of a leading pharmaceutical organization.
• Our client fosters a collaborative and supportive remote work culture, ensuring you have the resources needed to excel in your role from anywhere in South Africa .