PK Medical Writer

Purpose: Deliver high quality relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g. population PK/PD data transfer plans, population PK/PD analysis plans and population PK/PD reports), as well as CSRs, protocols, and other documents, within the required regulatory system per global aligned procedures of the client.

Documents that the writer will be doing include:

• CSRs for phase 1 healthy volunteer trials and clinical pharmacology trials. 

• Protocols for healthy volunteer studies.

• Module 2.7.1 and 2.7.2

Expectations:

• Write clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents

• Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers.

• Provide scientific and medical writing consultancy to project teams, as requested.

Deliverables:

• Services rendered will adhere to applicable client’s SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc. 

• Clear communication with clinical pharmacology & pharmacometrics leaders and other team members.

• Ensure deliverables are inspection ready and compliant with relevant requirements.

• Maintain the central planning of population PK/PD document writing and QC deliverables.

Your profile

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.

• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills, and the ability to communicate scientific concepts to diverse audiences.

• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process.

• Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables.

• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes.