Medical Writer II

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Oversee the preparation of medical writing documents, which includes coordinating assignments to writers, conducting reviews, and performing substantive editing.

• Take primary responsibility when required for critical regulatory response documents and materials that support significant regulatory submissions.

• Develop writing strategies, establish timelines, and evaluate resource needs for essential documents and regulatory submissions.

• Engage in relevant project teams and task forces.

• Offer functional and cross-functional guidance on document preparation, international regulatory standards, work requirements, and project or therapeutic area-specific advice.

• Direct writing strategies concerning organization, content, timelines, and resource allocation.

• Contribute advanced insights for study designs, analysis plans, sections of INDs, and marketing applications.

• Review and edit contributions substantially while ensuring the resolution of any issues.

• Manage deliverables and document preparation for submission to regulatory bodies.

• Ensure content consistency and compliance with regulatory and sponsor requirements across development initiatives.

• Represent Medical Writing on cross-functional teams and task forces.

• Serve as a primary Medical Point of contact regarding clinical regulatory strategy.

• Act as the lead writer for vital regulatory response documents and key elements of regulatory submissions.

• Provide leadership within functional teams addressing document preparation and production challenges or requirements.

• Execute medical writing tasks independently with minimal supervision as a Principal Medical Writer.

⛳️ Requirements

• A Bachelor’s degree in a science or health profession is required.

• A minimum of 3 years of experience in writing for the pharmaceutical or biotechnology industry is preferred.

• At least 3 years of experience with electronic documents and submissions is required.

• Experience in crafting key documents such as Clinical Study Reports, Investigator Brochures, and Protocols.

• A solid understanding of clinical development, including its phases, processes, and techniques from protocol design through regulatory submission and support for marketed products.

• Familiarity with international regulations, ICH guidelines, and relevant international regulatory processes related to document preparation and production (including CTDs).

• Highly developed oral and written communication skills.

• Ability to effectively present technical information within and across functional domains.

• Proven problem-solving and interpersonal abilities that foster effective interactions within functional and cross-functional teams and with external providers.

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs that include medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.