Global Submissions Publishing Specialist (Regulatory Affairs)

Job Description

Position Title

Specialist, Global Submissions Publishing (GSP)

Department

Regulatory Planning and Publishing (RPP)

Brief Description of Position

Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions.

Submission Publishing is responsible for assembling, linking, and delivering high-quality regulatory dossiers to health authorities, facilitating expeditious agency reviews that align with industry cycle times.

Key Responsibilities of Submission Publishing:

- Submission Activities Support : Execute the comprehensive publishing process, including quality control, verification, finalization, delivery of submission dossiers and archiving to ensure compliance with industry standards and regulatory requirements.

- Timely Completion of Submission Assemblies : Ensure that all dossiers are finalized and submitted by the specified deadlines to uphold project schedules and achieve organizational objectives.

Shared Responsibilities:

- Collaboration : Collaborate with authors, contributors and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success.

- Testing and Implementation of New Tools and Processes : Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness.

- Development of Administrative Documentation : Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines and training materials to support publishing processes.

- Continuous Learning and Development : Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences.

- Risk Management and Issue Resolution : Identify, assess, and actively resolve or escalate any risks or issues that could impact the successful completion of submissions. Collaborate with cross-functional teams to ensure timely identification and mitigation of potential challenges.

- Mentoring : Provide mentoring to inter-departmental and external stakeholders to enhance understanding and compliance with regulatory requirements.

Qualifications, Skills & Experience

Education Minimum Requirement:

- Bachelor’s Degree plus 5 years of relevant experience
- Fluent- Full English Porcifiency
- Publishing experience
- Familiarity with tools like, with tools such as: Veeva, Insight Publisher, Lorenz Docubridge
- Computer Systems Aptitude

Required Experience:

- Interpersonal Skills : Ability to work collaboratively with others and communicate effectively, both verbally and in writing.

- Technical Proficiency : Proficient in computer programs such as MS Word and Adobe Acrobat Professional, with a demonstrated ability to learn new systems and technologies quickly.

- Time Management : Strong organizational skills to manage multiple time-sensitive assignments efficiently.

- Adaptability : Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures.

- Cultural Sensitivity : Good interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages.

- Quality and Compliance Awareness : Demonstrates an understanding and executes the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables.

- Problem Solving and Critical Thinking : Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges.

Required Skills:
Adaptability, Adaptability, Compliance Activities, Conceptual Thinking, Continuous Development, Critical Thinking, Detail-Oriented, Documentation Preparation, Document Management, Efficiency Improvements, Electronic Common Technical Document (eCTD), Employee Training Programs, Lateral Thinking, Microsoft Word, Multitasking, Operational Efficiency, Performance Improvements, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Problem Identification, Process Improvements, Product Delivery, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications {+ 9 more}

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

Employee Status:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
10/23/2026
*A job posting is effective until 11:59:59PM on the day BEFORE  the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.