Quality Control and Medical Writing Manager
Posted Mar 28, 2022
TFS is currently supporting Pharmetheus with their recruitment to find their next Quality Control (QC) Medical Writer (MW) Manager.
As a QC/MW Manager, you will be responsible for the day-to-day operations in the QC/MW team, including scoping of tasks, resource allocations, and line management of assigned staff (4-6 QC/MWs). You will also take an active role in developing and implementing business related strategies and processes.
The role also entails working as a QC reviewer and medical writer. This may include QC review of analyses, and reports and by providing medical writing support for reports and publications.
As Manager for the QC/MW-team, you will report to Pharmetheus Quality Assurance Officer.
Training will be provided in the QC methodology applied at Pharmetheus. Depending on your background, training in pharmacokinetics and pharmacometrics may also be provided.
Pharmetheus is a well-recognized provider of consulting services focused on pharmacometric analyses (modelling and simulation) in support of drug development decisions. Our highly skilled and enthusiastic team brings considerable value to clients and partners, with the ultimate aim to change patients' lives. We are a motivated, dedicated and growing group of close to 70 people. The company has a mix of academic experts and experienced consultants, with a warm, friendly workplace environment where every person’s idea and opinion matter. Your future colleagues are all driven and highly devoted to pushing the limits within the area. Pharmetheus is currently undergoing exciting developments and is looking to expand its capacities and capabilities in quality control review and medical writing.
- Life Science Master’s degree or PhD
- Several years of experience in medical/scientific writing combined with scientific and regulatory knowledge
- Several years of experience from drug development gained in the pharmaceutical industry, regulatory environment or in academia
- Several years of line/project management experience
- Experience in interpreting clinical data
It will be considered an advantage if you have:
- Experience with quality control review/analysis review
- Knowledge in pharmacokinetics and pharmacometrics
- Experience with the software environment for statistical computing and graphics, R
- Excellent written and spoken scientific English
- Strong interpersonal and communication skills and a personal engagement
- Strong leadership skills with a proven ability to develop and manage team performance and to work effectively
- Highly developed analytic mindset with the eye for details
- Used to keep deadlines
- Used to manage a diverse and time-sensitive workload
- Good IT skills and use of standard office tool
If you have any questions about this opportunity please e-mail Claudia.JorgensenRankine@tfscro.com.
Interviews will be held on a ongoing basis.
Looking forward to receiving your application!Apply for this job