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Job Title : Medical WriterJob Description

The Medical Writer is responsible for independently planning, preparing, writing, reviewing, editing, formatting, and finalizing clinical and regulatory documents. This role requires effective collaboration with various departments, critical thinking in presenting scientific concepts, and ensuring compliance with regulations and internal guidelines.

Responsibilities

• Plan, prepare, write, review, edit, format, and finalize clinical and regulatory documents such as clinical protocols, clinical study reports, investigator's brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, and regulatory responses.
• Coordinate the internal review and approval of documents.
• Collaborate effectively with Clinical Research and Development colleagues and other departments including regulatory, safety, biostatistics, clinical operations, medical affairs, and the commercial group.
• Demonstrate critical thinking in the presentation of scientific concepts and objectives.
• Assist with gathering documents required for completing submissions, such as signatures and appendices, by liaising with cross-functional departments.
• Represent Medical Writing on project teams, advising teams on content and format requirements for various documents and coordinating writing activities for document development, including timelines and review / revision responsibilities.
• Coordinate deliverables with external vendors, if needed.
• Manage and work with external teams on joint venture / partnered projects, including the review of documents.
• Stay informed of regulations and developments in medical writing and maintain knowledge of product areas, current trends, and current literature.

Essential Skills

Additional Skills & Qualifications

Work Environment

The work environment involves collaborating cross-functionally with various departments, managing and coordinating document deliverables, and ensuring compliance with regulatory standards. The role requires staying informed about current trends and literature in the field, and working effectively in a team setting.

Pay and Benefits

The pay range for this position is $80.00 - $120.00 / hr.

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Dec 10, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through :

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.