Team Leader Regulatory Editor
hace 2 semanas
**Join us on our exciting journey**
We are looking for a **Team Leader Regulatory Editor**, this could be your chance to start a new adventure in a company with the best Regulatory Talents.
In this role you will be joining part of a new team of experienced regulatory intelligence analysts during a period of strong growth. Working in a team that creates intelligence for one of the leading regulatory teams in the industry.
**POSITION PURPOSE**:
Proactive monitoring and surveillance on changes in the global regulatory landscape covering the drug development lifecycle starting from preclinical through commercialization as well as the medical devices from concept stage to market. This position will provide broad support on clinical, pharmacovigilance and manufacturing quality activities and requests.
**MAIN RESPONSABILITIES**:
**Managerial Skills**:
- Support project objectives.
- Provide direction, support and feedback within the Business Analysis team.
- Perform team lead duties including scheduling, reporting to management, supervising analysts, delegating and prioritizing workloads.
- Resolve issues within and across teams.
**Editorial Skills**:
- Monitor and analyse the changes and evolution of the local regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders for both drug and medical devices.
- Assess regulatory intelligence information for relevance and impact to industry’s internal processes, drug development projects and/or regulatory strategies to create and enrich the IQVIA proprietary documents.
- Monitoring agency and professional websites, local specialized press, conferences and selecting documents to be integrated in line with the IQVIA scope, editorial and intelligence management processes
- Identify business critical aspects and communicate effectively to internal and external stakeholders. This includes regular updates on new information that could impact clinical trial execution, pharmacovigilance activities, manufacturing quality as well as other ad hoc requests.
- Synthesize information from regulatory documentation as well as interaction with local country experts as needed.
- Share/Input data into systems or tools to enable effective knowledge management of country level operational intelligence data.
- Develop and refine regulatory intelligence processes and procedures to build efficiencies
- Scientific degree in pharmacy, chemistry, pharmacology, biology
- Proficient in proof reading and editing in English language
- Proficient in at least one more language other than English
- Capability to work remotely with peers in an international environment
- Good understanding of the drug development and commercialization process
- Ability to research, analyse and extrapolate critical regulatory information
- Highly organized and able to work independently to meet deliverable on time and on target
- Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization and externally
- Attentive to details and focused on quality output
- Effective communicatorboth written and oral - in a multi-discipline team environment
- Proficient in the navigation of intelligence database(s)
- IQVIA is an **equal opportunity employer**. We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status.“
**We invite you to join IQVIA**
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, **we invite you to reimagine healthcare with us**. You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there
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