PK Medical Writer (Pharmacokinetics)
PK Medical Writer (Pharmacokinetics)
ICON
Job description
Looking to build a career in clinical pharmacology and pharmacometrics writing? Explore this PK Medical Writer role at ICON, based remotely in Bangalore.
Company Description
ICON is a world leader, in healthcare data and clinical research. The team is proud of creating a space that fuels real innovation and high quality. Together ICON works toward one shared goal of shaping the future of trials. ICON continues to grow helping bring new medicines and treatments to patients more quickly through strong teamwork and scientific skill.
Job Summary
This remote role focuses on writing clinical pharmacology and pharmacometrics documents for global clients. As a PK Medical Writer, you will prepare population PK and PD analysis plans, clinical study reports, protocols, and related regulatory documents. Your work will follow the client's global procedures and required regulatory standards. The role also involves close coordination with clinical pharmacology leaders and cross functional project teams.
Key Responsibilities
Write clinical study reports for phase one and clinical pharmacology trials.
Prepare protocols for healthy volunteer studies.
Draft Module 2.7.1 and 2.7.2 documents for regulatory submissions.
Write clear, concise reports, protocols, investigator brochures, and scientific documents.
Lead the document preparation process, from drafting to final review.
Review statistical output and resolve reviewer comments across each document.
Offer scientific and medical writing guidance to project teams, when needed.
Follow client SOPs, work instructions and regulatory requirements that are applicable.
Communicate clearly with the leaders of the pharmacology team and the leaders of the pharmacometrics team.
Keep all deliverables inspection ready and fully compliant at all times.
Maintain the planning schedule for population PK and PD writing work.
Educational Qualification
Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field.
Skills Required
3 - 5 years of experience in writing within pharma, biotech or a CRO.
Strong ability to interpret and summarize clinical trial data.
Excellent writing, editing and proofreading skills.
Good understanding of requirements including ICH GCP, FDA and EMA guidelines.
Having experience interacting with agencies during document review is a plus.
Being able to manage projects in a paced deadline driven environment is important.
Strong interpersonal skills help interpersonal skills work well with teams.
Salary Structure
The PK Medical Writer role at ICON with 3 to 5 years of experience generally pays between ₹5.5 lakh and ₹9.5 lakh per annum in India.
Career Development
This role offers hands on exposure to regulatory writing within a respected global research organization. ICON also supports long term growth through benefits wellbeing programs and opportunities to build a lasting career, in medical writing.
How to Apply
Visit our job portal and search for the PK Medical Writer role - ICON.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.