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- Tasks: Coordinate and manage Clinical Pharmacology documents for regulatory compliance.
- Company: IQVIA is a global leader in clinical research and healthcare intelligence.
- Benefits: Enjoy a full-time role with opportunities for professional growth and development.
- Why this job: Join a dynamic team making a real impact on patient outcomes worldwide.
- Qualifications: BA/BS in health, science, or computer science; experience in pharmaceutical industry preferred.
- Other info: This role is not eligible for UK visa sponsorship.
The predicted salary is between 36000 - 60000 £ per year.
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Deliver high quality coordination of the centralized support by the document service management group for upload of relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g. population PK/PD data transfer plans, population PK/PD analysis plans and population PK/PD reports) within the required regulatory system per global aligned procedures of client. Perform memo and report strawman support, document quality control (QC), prepare Clinical Pharmacology & Pharmacometrics documents for submission or health authority interactions, provide writing support, implement QC process refinement as defined by the Clinical Pharmacology & Pharmacometrics organization, and track the operational progress amongst stakeholders. Services are delivered by applying organizational and scientific writing skills to support document writing and QC in line with applicable guidelines and regulations.
Responsibilities
- Clear communication with clinical pharmacology & pharmacometric 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.
- Provide advice/recommendation on process improvements in support of interactions between Clinical Pharmacology & Pharmacometrics and the document service management group.
- Drive the PK/PD document shell writing, document QC process, management of deliverable timelines; receive, and review documents (e.g. reports), compile comments and edits; follow up on comment resolution in close collaboration with the team.
- Provide PK/PD document QC of reports and manage the review process, documentation within QC checklist, including comment resolution follow up, within projected timelines, in line with the analysis plan and internal guidelines.
- Support the development of CPP reporting templates, analysis plans, data transfer plans, as required in close partnership with the document service management group.
Education and Experience Requirements/Qualifications:
- Minimum degree: BA/BS Degree in a health, science, or computer science related field.
- Strong experience working in Pharmaceutical or CRO Industry
- Proficient with word templates and document formatting.
- Experienced in scientific report writing and document QC procedures.
- Project Management and organizational skills, ability to prioritize multiple projects.
- Proficient in speaking and writing in English. Effective communication skills, oral and written.
- Experience in population PK/PD report writing and review is preferred.
This role is not eligible for UK visa sponsorship
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Administrative
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Industries
Pharmaceutical Manufacturing
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Frankfurt am Main, Hesse, Germany 1 day ago
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PK/PD Documentation Specialist (m/w/d) employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land PK/PD Documentation Specialist (m/w/d)
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements and guidelines related to Clinical Pharmacology and Pharmacometrics. Understanding these will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the pharmaceutical and CRO industries, especially those who have experience in PK/PD documentation. Engaging in conversations can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Brush up on your project management skills, as this role requires the ability to manage multiple deliverables. Consider using tools like Trello or Asana to showcase your organisational capabilities during discussions.
✨Tip Number 4
Prepare to discuss your experience with document quality control processes in detail. Be ready to share examples of how you've improved QC procedures in past roles, as this will highlight your proactive approach.
We think you need these skills to ace PK/PD Documentation Specialist (m/w/d)
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the PK/PD Documentation Specialist role. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in the pharmaceutical or CRO industry, particularly any work related to population PK/PD report writing and document quality control procedures.
Showcase Your Skills: Clearly demonstrate your project management and organisational skills in your application. Provide examples of how you have prioritised multiple projects and ensured compliance with relevant requirements in past roles.
Craft a Strong Cover Letter: Write a compelling cover letter that not only outlines your qualifications but also explains why you are passionate about the role and how you can contribute to the team at IQVIA. Make sure to address specific aspects of the job description.
How to prepare for a job interview at IQVIA
✨Understand the Role
Make sure you have a clear understanding of the PK/PD Documentation Specialist role. Familiarise yourself with clinical pharmacology and pharmacometrics concepts, as well as the specific responsibilities mentioned in the job description.
✨Showcase Your Writing Skills
Since the role involves scientific report writing and document quality control, be prepared to discuss your previous writing experiences. Bring examples of documents you've worked on, and be ready to explain your approach to ensuring compliance and quality.
✨Demonstrate Project Management Abilities
Highlight your project management skills during the interview. Discuss how you prioritise tasks, manage timelines, and coordinate with team members to ensure deliverables are met on time and to a high standard.
✨Prepare for Technical Questions
Expect technical questions related to document formatting, QC procedures, and population PK/PD report writing. Brush up on relevant guidelines and regulations to demonstrate your expertise and readiness for the role.