Medical Writer

This is a fully remote position, open to applicants in United Kingdom, +4 more states.

📋 Description

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

• Produce high-quality Clinical Pharmacology & Pharmacometrics documents, which encompass population PK/PD data transfer plans, analysis plans, and reports.

• Compose clinical study reports for phase 1 healthy volunteer and clinical pharmacology trials.

• Develop protocols for studies involving healthy volunteers.

• Prepare Module 2.7.1 and 2.7.2 documentation.

• Author study reports, protocols, investigator brochures, summary documents, and various other scientific materials.

• Facilitate document preparation, review primary statistical outputs, draft and circulate documents, and address or resolve reviewer feedback.

• Offer scientific and medical writing consultancy to project teams.

• Liaise with clinical pharmacology and pharmacometrics leaders as well as other team members.

• Ensure that deliverables are ready for inspection and comply with relevant standards.

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

⛳️ Requirements

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

• Have a minimum of 3–5 years of medical writing experience within the pharmaceutical, biotechnology, or contract research organization sectors.

• Demonstrate proficiency in interpreting and summarizing intricate clinical trial data, scientific research outcomes, and statistical analyses.

• Exhibit excellent writing, editing, and proofreading capabilities.

• Ability to convey scientific concepts to varied audiences effectively.

• Strong grasp of regulatory requirements, including ICH-GCP, FDA, and EMA guidelines.

• Experience in interacting with regulatory bodies throughout the review and approval stages.

• Capacity to thrive in a fast-paced, deadline-oriented setting.

• Skill in managing multiple projects concurrently and prioritizing tasks in alignment with project timelines and deliverables.

• Exceptional interpersonal and communication abilities.

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

• 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, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Learning and development opportunities through structured training and career pathways.

• An inclusive and accessible workplace.

• Reasonable accommodations provided during the recruitment process.

• A diverse company dedicated to sustainability and community support.