Senior Specialist, Regional Dossier Publisher - #1159071
Join us and be part of our purposeful journey of invention!
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
The Regional Dossier Publisher (RDP) will work within the our company Global Regulatory Affairs and Clinical Safety organization, in the Regulatory Affairs Operations Latin America department. Also, is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by our decentralized publishing team who are working on dossiers for the region. And will have a good knowledge of the regulatory procedures and requirements in the region and be able to apply this to the publishing processes and tools to ensure that the submissions delivered to the Country Regulatory Affairs groups meet their specific needs.
The Regional Dossier Publisher will also be involved with supporting Country Regulatory Affairs teams with their local publishing and submission transmission needs and ensure they can meet their submission deadlines. In addition, will also work with colleagues from the Head Quarters publishing functions to assist in the development of the tools and procedures that support our submission planning and publishing procedures.
- Bachelor’s Degree in Life Sciences, Pharmacy, Engineering or IT.
- Minimum of three (3) years of regulatory and/or pharmaceutical experience.
- Knowledge of Liquent Insight Publisher or other publishing tools will be considered as a plus.
- Strong analytical and customer service skills with the ability to work with varying grade levels, educational background and departments.
- Excellent interpersonal skills and oral and written communication skills.
- Demonstrated ability to work under tight deadlines.
- Proven attention to detail and ability to work with a variety of technical applications.
- Proficiency in English and Spanish, in oral and written.
- Willing to travel 10% of the time.
- Working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum, etc.)
- Knowledge of publishing requirements in the LATAM region.
- Knowledge of the regulatory registration procedures in the LATAM region will be considered as a plus.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:Remote Work
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