Participant Narrative Medical Writer Fellowship (Remote) - Hiring Our Heroes

Job Requirements

We are honored to be a sponsor of Hiring Our Heroes and proud to offer transitioning service members this opportunity to gain professional experience in a 12-week fellowship program.

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 empathy, creativity, digital mastery, or scientific genius 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 Clinical Trail Operations (GCTO) is a global organization with over 3,800 people operating in 47 countries, responsible and accountable for the execution of our clinical research portfolio. The Medical Writing Department of the GCTO organization prepares various regulated documentation in support of the clinical development portfolio. Clinical Study Reports (CSR) and Safety Update Reports (SUR) are two document types written and delivered by Medical Writing. One of the regulatory content requirements for these two document types is participant narratives describing data-driven information on the specific adverse event(s) reported during a clinical trial.

This is an excellent opportunity to develop an understanding of the regulatory requirements for safety reporting and hone writing skills with a focus on safety in support of clinical trials. You will be part of a diverse, cross-functional team of individuals who execute our clinical trials. The Fellowship will include progressive on-the-job training and operational project assignments under the direction of Lead Safety Medical Writers to write and deliver participant narratives.

Your Fellowship Project

You will partner with team members to train on data structure, narrative content, and the tools used to support the delivery of the participant narrative. After the training, you will be incorporated into a team of narrative writers and assigned different projects to support the writing and delivery of the participant narrative.

The fellowship intends to:

• Develop an understanding of the content and structure of a Clinical Study Report (CSR) and the relationship to the participant narratives relevant to the CSR
• Develop an understanding of the ICH3 guidelines for what a participant narrative should describe
• Develop an understanding of the data collection tools and visualization of the source data to describe the adverse events(s) as required by the ICH3 guidelines
• Participate in project team meetings to develop an understanding of the different skills and expertise needed for the delivery of a CSR

Benefits of Fellowship

• Mentoring & networking opportunities within and beyond Medical Writing
• Exposure to Senior level positions within the clinical development forum
• Hands-on experience in reviewing data and writing participant narratives for adverse events of interest
• Opportunity to hone writing skills

Experience/Skills We are Looking for:

• Strong communication abilities, including written, verbal, and interpersonal
• Life Sciences, scientific, medical, or nursing education background
• 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 Microsoft Word, SharePoint, Excel, and PowerPoint

Primary Work Site/Schedule

• On-site locations Rahway, NJ; Upper Gwynedd, PA; Boston, MA; or Remote
• Monday-Thursday (Core hours: 9:00 am – 4:40 pm, flexible start and stop)

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

Requisition ID:P-100674