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Associate Publishing Specialist, Regulatory Planning and Publishing (RPP)
Associate Publishing Specialist, Regulatory Planning and Publishing (RPP)-September 2024
Upper Gwynedd
Sep 23, 2024
ABOUT MERCK
Merck enables a safe, sustainable and healthy future for people and communities everywhere...
10,000+employees
Healthcare
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About Associate Publishing Specialist, Regulatory Planning and Publishing (RPP)

  Job Description

  Global Submissions 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 format, as well as our company's internal guidelines for electronic/hardcopy submissions.

  The incumbent will support global process; executing end-to-end document and/or submission assembly which includes formatting, document management system support, publishing, peer review, quality control verification, finalization, delivery, and archive, as applicable to the role. This requires collaborative interaction with component providers and submission planners to ensure quality, right first-time output, and timeliness. This can include providing content providers with formatting assistance as well as guidance with regards to submission standards and referencing processes.

  Additionally, the incumbent may be involved in assisting with developing administrative documentation, and involvement with the testing and implementation of new tools and processes.

  Required Experience & Skills:

  High school diploma or equivalent

  Demonstrated ability to work with others.

  Proficient with computer systems such as MS Word and Adobe Acrobat Professional, and adept at learning new systems and technology

  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 problems that arise within job responsibilities and expectations of this role.

  Effectively communicates situations both verbally and in writing with an appropriate sense of urgency.

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

  Desired Experience & Skills:

  Basic understanding of document management concepts and awareness of submission publishing process

  Exposure to a pharmaceutical/biotechnology industry or regulatory publishing environment.

  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.

  Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

  Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

  Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

  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) if you need an accommodation during the application or hiring process.

  We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

  EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

  EEOC GINA Supplement​

  Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.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.

  Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

  U.S. Hybrid Work Model

  Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

  Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

  Expected salary range:

  $68,400.00 - $107,700.00

  Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

  Search Firm Representatives Please Read Carefully

  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:

  No relocation

  VISA Sponsorship:

  No

  Travel Requirements:

  10%

  Flexible Work Arrangements:

  Hybrid

  Shift:

  1st - Day

  Valid Driving License:

  Yes

  Hazardous Material(s):

  N/A

  Requisition ID: R277656

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