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- Aufgaben: Lead a dynamic team in medical writing and safety reporting.
- Arbeitgeber: Join Product Life Group, a leader in medical information and vigilance.
- Mitarbeitervorteile: Enjoy remote work flexibility and a permanent contract.
- Warum dieser Job: Make an impact in patient safety while collaborating with experts.
- Gewünschte Qualifikationen: Bachelor's or Master's in Pharmacy or life sciences; 8+ years in pharmacovigilance.
- Andere Informationen: Experience with audits and inspections is a plus.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
Product Life Group is looking for Director-Medical Writing to join our dynamic PV team.
Responsibilities
- Experienced in handling the team and support in MW
- Working closely with QPPV and aware of QPPV role
- Periodic Safety Update Report (PSUR/PBRER/PADER)
- Addendum to Clinical Overview (ACO)
- Development safety update report (DSUR)
- Risk management plans (RMP)
- Signal Detection Reports
- Experienced in providing the responses of assessment reports from agencies
- Ability to attend customer facing remote meetings & F2F meetings and communication
- Analysis and assessment of benefit/risk profile of the products
- Ability to participate in clients audits and inspections
- Good interpersonal skills, support in utilization of the team members
- PSMF, SDEA and PV TA review and finalization
Required Education
Bachelor or Master of Pharmacy, life science, Medical degree
Required Experience
More than 8 years of experience in PV
Technical Skills
Knowledge of the relevant EU regulations and GVP Modules
Additional Experience
- Audits and Inspections experience would be an advantage
- Good interpersonal skills, team player and excellent communication skills
- Good team handling skills
Director-Medical Writing Arbeitgeber: ProductLife Group
Kontaktperson:
ProductLife Group HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Director-Medical Writing
✨Tip Number 1
Make sure to highlight your experience in handling teams and your familiarity with the role of QPPV. This will show that you have the leadership skills necessary for the Director-Medical Writing position.
✨Tip Number 2
Demonstrate your knowledge of relevant EU regulations and GVP Modules during interviews. Being well-versed in these areas is crucial for this role and will set you apart from other candidates.
✨Tip Number 3
Prepare to discuss your experience with audits and inspections, as this is a valuable asset for the position. Sharing specific examples can help illustrate your expertise.
✨Tip Number 4
Showcase your excellent interpersonal and communication skills. Since the role involves customer-facing meetings, being able to convey your ideas clearly and effectively is essential.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Director-Medical Writing
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly understand the responsibilities and requirements of the Director-Medical Writing position. Highlight your experience in handling teams, working with QPPV, and your familiarity with PSURs, DSURs, and risk management plans.
Tailor Your CV: Customize your CV to emphasize your relevant experience in pharmacovigilance and medical writing. Include specific examples of your work with safety update reports and your ability to analyze benefit/risk profiles.
Craft a Compelling Cover Letter: Write a cover letter that showcases your interpersonal skills and team handling abilities. Mention your experience with audits and inspections, as well as your capacity to participate in client-facing meetings.
Proofread Your Application: Before submitting, carefully proofread your application materials for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in medical writing.
Wie du dich auf ein Vorstellungsgespräch bei ProductLife Group vorbereitest
✨Showcase Your Leadership Skills
As a Director of Medical Writing, you'll be expected to handle a team effectively. Be prepared to discuss your previous experiences in team management and how you support your team members in achieving their goals.
✨Demonstrate Regulatory Knowledge
Familiarize yourself with EU regulations and GVP Modules relevant to medical writing. During the interview, highlight your understanding of these regulations and how you've applied them in past roles.
✨Prepare for Client Interactions
Since the role involves attending customer-facing meetings, practice articulating your thoughts clearly and confidently. Share examples of how you've successfully communicated complex information to clients in the past.
✨Discuss Audit and Inspection Experience
If you have experience with audits and inspections, be ready to discuss specific instances where you contributed to successful outcomes. This will demonstrate your preparedness for the responsibilities of the role.
