Specialist License Management At Merck. Interested candidates can check the details below and apply online.
Job role: Specialist License Management
Job ID: 265268
Location: Electronic City Phase 1 – Bangalore
Working time model: full-time
About Us:
As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference in millions of people’s lives. Discover how Merck uses science to drive human progress!
Role: of Specialist License Management At Merck
The Specialist License Management prepares dossiers and execute actions that support the license security and product compliance on the markets, and that meet company’s and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach.
Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to work on complex tasks and to propose solutions and strategies as part of their day to day work.
Experience:
- Minimum 4 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role.
- Minimum 3 years of Regulatory affairs experience.
Education: Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
Career Level: D – Professional (4-9 years)
Job Specific Competencies & Skills:
- Ability to contribute to the dossier content and to perform content and quality review on regulatory documentation
- Ability to develop and prepare successful regulatory strategies and dossiers
- Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations
- Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
- Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirements
- In Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc.) and LCM strategies
- Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request
- Strong project management and documentation skills, proactive communication approach
- Ability to execute appropriate risk assessment and mitigation in cooperation with line manager /team lead
- Ability to provide Regulatory expertise into the planning and execution of projects and tasks
- Ability to work within a matrix organisation, build relationships with internal or external stakeholder
- Contributor level experience with Veeva Vault Registration module and EDMS RA applications
- Excellent written and spoken communication skills and English language knowledge
We have several openings for License Management roles for various levels and profiles
Expectations and scope of responsibilities provided in this Job posting are for Specialist level
The exact designation to be offered will depend on applicants’ experience and knowledge confirmed during the screening process
What we offer:
- We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
- We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.
- We are committed to creating access and opportunities for all to develop and grow at your own pace.
- Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.
Here are few interview questions with answers to do good at the interview for the role of Specialist License Management At Merck:
1.Can you explain your experience in preparing regulatory strategies and dossiers for license management? Provide an example of a successful regulatory strategy you developed.
Answer:
In my previous role as a Regulatory Affairs Specialist, I was responsible for preparing regulatory strategies and dossiers for license management. One example of a successful regulatory strategy I developed was for a new product application in the European market. I conducted a thorough analysis of the regulatory requirements, including the applicable guidelines and regulations. Based on this analysis, I identified key milestones, submission timelines, and the necessary documentation for the application. I collaborated closely with cross-functional teams, including R&D, quality assurance, and clinical affairs, to gather the required data and ensure its accuracy and completeness. By implementing a proactive communication approach and utilizing my project management skills, I successfully executed the regulatory strategy, resulting in the timely approval of the license.
2.How do you stay updated with country-specific and international regulatory guidelines, policies, and regulations? Give an example of how you used this knowledge to generate submission-ready deliverables.
Answer:
To stay updated with country-specific and international regulatory guidelines, policies, and regulations, I regularly participate in industry conferences, workshops, and training programs. I also subscribe to regulatory newsletters and publications, and actively engage in online forums and discussion groups related to regulatory affairs. Additionally, I maintain close connections with regulatory authorities and industry experts to gather insights into upcoming changes and requirements.
3.Describe your experience in working within a matrix organization and building relationships with internal and external stakeholders. How did you ensure effective collaboration and communication?
Answer:
Throughout my career, I have gained extensive experience in working within a matrix organization and building relationships with stakeholders from various functions, both internal and external. To ensure effective collaboration and communication, I employ the following strategies:
1. Establishing clear lines of communication: I proactively reach out to relevant stakeholders, ensuring everyone is informed about the project’s progress, timelines, and any changes or updates. I leverage various communication channels such as emails, meetings, and collaborative platforms to foster transparent and efficient communication.
2. Building rapport: I invest time in building rapport and trust with stakeholders by actively listening to their perspectives, acknowledging their expertise, and demonstrating a collaborative mindset. This approach fosters a positive working relationship, encourages open dialogue, and promotes shared decision-making.
3. Understanding stakeholder needs: I make an effort to understand the needs and priorities of each stakeholder group involved in the license management process. By aligning our goals and finding common ground, I facilitate smoother collaboration and ensure that everyone’s perspectives are considered.
4. Resolving conflicts: In a matrix organization, conflicts may arise due to competing priorities or differing opinions. I address conflicts by facilitating constructive discussions, seeking win-win solutions, and leveraging my interpersonal skills to encourage compromise and consensus.
4.Describe your experience with Veeva Vault Registration module and EDMS RA applications. How have you utilized these tools in your previous roles?
Answer:
In my previous roles, I have gained hands-on experience with the Veeva Vault Registration module and EDMS RA applications. These tools have been instrumental in streamlining regulatory affairs processes and enhancing document management efficiency. With the Veeva Vault Registration module, I have utilized its features to manage and track regulatory submissions, milestones, and documentation. I have leveraged its capabilities to compile and organize submission-ready dossiers, ensuring the accurate inclusion of all required information.
Specialist License Management At Merck
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