Medical Writer

This is a fully remote position, open to applicants in United Kingdom, +9 more countries.

📋 Description

• Oversee the formulation and implementation of medical writing strategies for clinical research initiatives.

• Produce high-quality Clinical Pharmacology & Pharmacometrics documentation, including plans for population PK/PD data transfer, analysis plans, and reports.

• Draft Clinical Study Reports (CSRs), protocols, study reports, and other scientific documents.

• Lead the document preparation process effectively.

• Receive and evaluate primary statistical outputs.

• Create and circulate documents for feedback and review.

• Integrate and address feedback from all reviewers.

• Offer scientific and medical writing consultancy to project teams.

• Comply with client Standard Operating Procedures (SOPs), Work Instructions (WIs), policies, local regulatory standards, and ICH-GCP guidelines.

• Maintain clear communication with clinical pharmacology and pharmacometrics leaders, as well as other team members.

• Ensure that deliverables are prepared for inspection and align with relevant requirements.

• Oversee the centralized planning of population PK/PD document writing and quality control deliverables.

⛳️ Requirements

• An advanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline.

• At least 3-5 years of medical writing experience within the pharmaceutical, biotechnology, or contract research organization (CRO) sectors.

• Expertise in interpreting and summarizing intricate clinical trial data, scientific findings, and statistical analyses.

• Exceptional writing, editing, and proofreading capabilities.

• Proficiency in conveying scientific concepts to varied audiences.

• Comprehensive understanding of regulatory standards, including ICH-GCP, FDA, and EMA, related to the preparation and submission of clinical documents and publications.

• Experience engaging with regulatory bodies during the review and approval stages.

• Ability to thrive in a fast-paced, deadline-oriented environment.

• Competence in managing multiple projects concurrently and prioritizing tasks according to project timelines and deliverables.

• Strong interpersonal and communication skills.

• Capability to collaborate effectively with cross-functional teams, foster relationships with key stakeholders, and influence decision-making processes.

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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