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- Tasks: Coordinate and manage the upload of Clinical Pharmacology documents with precision.
- Company: Join IQVIA, a leader in clinical research and healthcare intelligence.
- Benefits: Enjoy flexible work options and a dynamic corporate culture.
- Why this job: Make a real impact on patient outcomes while developing your skills in a supportive environment.
- Qualifications: BA/BS in health, science, or computer science; experience in Pharma or CRO preferred.
- Other info: Ideal for those passionate about scientific writing and document quality control.
The predicted salary is between 36000 - 60000 £ per year.
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 Johnson & Johnson 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.
PK/PD Documentation Specialist employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land PK/PD Documentation Specialist
✨Tip Number 1
Familiarise yourself with the latest guidelines and regulations in Clinical Pharmacology & Pharmacometrics. This knowledge will not only help you understand the role better but also demonstrate your commitment to staying updated in this specialised field.
✨Tip Number 2
Network with professionals in the pharmaceutical and CRO industries. Attend relevant conferences or webinars, and connect with people on platforms like LinkedIn. Building relationships can often lead to job opportunities that aren't advertised.
✨Tip Number 3
Showcase your project management skills by discussing specific examples of how you've successfully managed multiple projects in the past. Highlighting your ability to prioritise and deliver on time will make you stand out as a candidate.
✨Tip Number 4
Prepare for potential interviews by practising answers to common questions related to document quality control and scientific writing. Being articulate about your experiences and how they relate to the role will boost your confidence and impress interviewers.
We think you need these skills to ace PK/PD Documentation Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the PK/PD Documentation Specialist position. Familiarise yourself with Clinical Pharmacology & Pharmacometrics terminology and processes.
Tailor Your CV: Highlight your relevant experience in the pharmaceutical or CRO industry, especially any work related to scientific report writing and document quality control. Make sure to emphasise your project management skills and proficiency with document formatting.
Craft a Compelling Cover Letter: In your cover letter, explain why you're a great fit for this role. Discuss your experience with population PK/PD report writing and how your skills align with the job requirements. Be sure to convey your effective communication skills and ability to collaborate with teams.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that your documents are clear, concise, and free of typos, as attention to detail is crucial for this role.
How to prepare for a job interview at IQVIA
✨Showcase Your Document Management Skills
Be prepared to discuss your experience with document management, particularly in the context of Clinical Pharmacology & Pharmacometrics. Highlight specific examples where you've successfully coordinated document uploads or maintained quality control processes.
✨Demonstrate Strong Communication Abilities
Since clear communication is key for this role, practice articulating your thoughts clearly and concisely. Be ready to provide examples of how you've effectively communicated with team members or stakeholders in previous roles.
✨Familiarise Yourself with Regulatory Requirements
Research the relevant regulatory guidelines that pertain to PK/PD documentation. Showing that you understand these requirements will demonstrate your commitment to compliance and readiness for the role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to manage multiple projects. Prepare scenarios from your past experiences where you had to prioritise tasks or resolve conflicts within a team.
