PK Medical Writer

Responsibilities

• Deliver high quality CPP documents such as population PK/PD data transfer plans, analysis plans and reports

• Write CSRs, protocols and other scientific documents

• Drive document preparation, review statistical output, and resolve reviewer comments

• Provide scientific and medical writing consultancy to project teams

• Ensure deliverables are inspection ready and compliant with SOPs and ICH-GCP

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

Requirements

• Advanced degree in Life Sciences, Pharmacy, Medicine or related field

• 3-5 years medical writing experience in pharma, biotech or CRO

• Ability to interpret and summarize clinical trial and statistical data

• Strong knowledge of ICH-GCP, FDA and EMA regulatory requirements

• Excellent writing, editing and proofreading skills

• Ability to manage multiple projects in a fast-paced environment

Preferred Qualifications

• Experience interacting with regulatory agencies during review and approval

Benefits

• Competitive base salary and performance related incentives

• Medical, dental and vision coverage where applicable

• Retirement and pension plans

• Life assurance and disability coverage

• Employee assistance programmes and learning opportunities

About the Company

• ICON is a world-class clinical research organisation and the largest FSP organisation, with over 90 sponsor partnerships.