South Dakota Veteran Jobs

South Dakota Department of Labor & Regulation
South Dakota Department of Labor & Regulation mobile logo

Job Information

Merck Submissions Sr. Specialist (Submission Publishing) in Pierre, South Dakota

Job Description

Submissions Publishing works closely with various stakeholders to ensure the timely completion of submission assemblies that adhere to both regulatory health authority and our company's guidelines for electronic/hardcopy submissions. The incumbent will support global process; executing end-to-end submission assembly which includes publishing, quality control verification, finalization and delivery. This requires collaborative interaction with component providers and submission managers to ensure quality, right first time output and timeliness. The incumbent will assume the role of lead publisher for larger, complex submissions (e.g. original marketing applications), which will include coordination of all publishing-related activities and delegation of activities to other publishers. Additionally, the incumbent will take the lead in the development of administrative documentation, provide inter-departmental and/or external stakeholder mentoring, and play an integral role in the testing and implementation of new systems, tools, and processes.

Primary responsibilities will include the following:

Publishing Support ( 60 %):

  • Work closely with submission managers to lead the production of high quality submission assemblies utilizing submission-ready documents that adhere to internal and external electronic submission guidelines

  • Ensure submission assemblies meet the level of technical integrity required for our company and health authority validation tools

  • Assume the lead for training/mentoring internal and external publishing staff

  • Assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right-first-time submission assemblies

  • Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions

  • Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies.

Administrative Support ( 40 %):

  • Assume the lead role in the development of publishing processes and documentation, including user acceptance testing for new and updated publishing tools. Delegation of these project activities to publishers within the department as needed.

  • Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders

  • Evaluate activities and business processes, identify areas in need of improvement and take the lead in investigating potential solutions or new ways of working

Qualifications

Education/Experience:

  • Required: Bachelor’s degree plus 5 years of regulatory publishing experience

  • Preferred: Bachelor’s degree plus 8 years of regulatory publishing experience

Required Experience:

  • In depth working knowledge of industry standard publishing systems and desktop applications including MS Word and Adobe Acrobat Professional

  • Expertise in eCTD publishing and other regulatory submissions standards

  • Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously

  • Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables

  • Demonstrates the ability to independently solve complex problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions

  • Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation

  • Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures

Preferred Experience:

  • Expertise with the Liquent InSight Publisher application

  • Expertise with industry standard electronic document management system

  • Experience with project management and leading teams

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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 …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA 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 …

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 .

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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.

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL [survey.sogosurvey.com]) if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

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.

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time, Remote Work

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R106694

DirectEmployers