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Publishing Support Specialist Fellowship

3 months ago

Arvada, Colorado, United States Merk Full time
Job Requirements

We are excited to be a sponsor of Hiring our Heroes and proud to offer transitioning service members a unique opportunity to gain valuable professional experience through our 12-week fellowship program.

During your fellowship with our company, you will have the chance to collaborate with our Veterans Leadership Network and receive support from various stakeholders within the organization. To ensure your success, each fellow is paired with a buddy who will provide guidance, mentorship, and different perspectives. Additionally, you will have access to a career development advisor who will offer support and guidance in managing your career.

As a fellow, you will be part of a Cohort consisting of other transitioning service members. This will enable you to engage in weekly touchpoints, attend educational sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to provide you with mentoring, networking opportunities, and exposure to help facilitate a successful transition into a full-time position within our company.

With our generous military-friendly policies, we've received accolades from several organizations such as GI Jobs, Military Times EDGE, and Employer Support of the Guard and Reserve (ESGR). Consider a future with us and discover an employer who will foster your best work as you continue to strive for the well-being of others.

Who we are ...

We are known as Merck & Co., Inc., in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your integrity, knowledge, imagination, skill, and teamwork to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Overview:

Global Regulatory Affairs and Clinical Safety – Operations, Processes and Systems (GRACS O.P.S.) is a global organization that drives core business operations and capabilities across our organization. The team is keenly focused on innovative business approaches and leveraging state of the art information management tools to enable effective and efficient execution of our processes. The team leverages its diverse skillsets to identify challenges across the operations of GRACS business and collaborates with the various functions to drive to resolution.

Successful candidates will be able to work independently as well as proactively collaborate with colleagues. Primary responsibilities will include assisting the Health Registrations Management team with the delivery of the new eCTD publishing software solution. The candidate will be an active team participant, attend team meetings and will complete Merck and vendor-based trainings on how to utilize and support the software solution effectively and compliantly. This candidate may be responsible for report creation that will help aid in making more efficient system-based decisions. The candidate may interact with internal and external stakeholders (SMEs, IT, vendors, sponsors, etc..) in support of successful project delivery.

You will be part of a diverse, cross-functional team of individuals who are responsible for delivering and supporting Crown Jewel, Mission Critical systems that directly aid in getting and keeping Merck products on the market, while adhering to Regulatory mandates for each respective, region around the world. The Fellowship will include progressive on-the-job training and operational project assignments under the direction of the Publishing Business System Owner.

Your Fellowship Project

You will partner with HRM team members to train on systems and tools to complete tasks and deliverables critical in the successful delivery of the new Submission Publishing system.

The fellowship intends to:

· Develop an understanding of the eCTD submission process (technical and regulatory fundamentals)

· Develop an understanding of the Regulatory Information Management evolving ecosystem

· Participate in team meetings to develop an understanding of the stakeholders and cross-functional team critical to the successful submission of Health Authority sequence

· Eventual mastery of publishing system

· Assistance with training and documentation

Benefits of Fellowship

· Mentoring & networking opportunities within and beyond GRACS OPS

· Exposure to Senior level positions within the Regulatory Affairs and partner functional areas

· Hands-on experience in the compilation and submission of Health Authority Regulatory drug submissions

· Development of critical analysis, hands-on/technical, and project management skills

Work Experience

Experience/Skills We are Looking for:

· Bachelor's +1 year of experience in life sciences setting Degree in information sciences, preferred

· Strong communication abilities, including written, verbal, and interpersonal

· Collaboration, project management, and organizational skills

· Ability to work with minimal supervision, prioritize activities and manage multiple tasks within deadlines

· Work experience in a results-driven environment

· Strategic/critical thinking

· Experience working on cross-functional teams

· Working knowledge of Adobe Acrobat, Microsoft Word, SharePoint, Excel, and PowerPoint

Primary Work Site/Schedule:

· On-site work location: Upper Gwynedd, PA; Hybrid schedule

· Monday-Thursday (Core hours: 9:00 am – 4:40 pm, flexible start and stop)

Requirement: Transitioning Service Member who is participating in the Hiring Our Heroes Corporate Fellowship Program

Fellowship Company Transition Opportunities: This Fellowship will be geared towards a Specialist position and does not align to a full time transition opportunity

Requisition ID:P-100836