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Senior Specialist, Non-clinical Pharmacology Document Writing (Hybrid)

Merck & Co., Inc.

$113,400 - $178,400 / year
Apply before: August 31, 2024
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  • Date posted
    May 1, 2024
  • Location
  • Salary
    $113,400 - $178,400 / year
  • Apply before
    August 31, 2024
  • Career Level

Job Description

Job Description


  • Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support the development of therapeutic agents and vaccines.

  • This includes but is not limited to scientific writing, data verification, and formatting, ‘ghost-writing’ reports. Interact with colleagues from multiple areas, including discovery, regulatory affairs, project teams, and development functions.

  • Partner with scientists and management to produce and edit nonclinical pharmacology reports and submission documents.

  • Create documents that effectively and clearly describe research results, product candidates, and other information required for regulatory submissions.

  • Ensure documents comply with regulatory and business guidelines in terms of content, format, style, and structure.

  • Assist in managing document authors/reviewers interface with our Company’s document system.


  • Strong computer skills, especially MS Word

  • Excellent writing skills

  • Ability to accept and integrate input from diverse sources and work effectively across multi-disciplinary work teams

  • Good understanding of scientific/biology terminology

  • Enjoy working in a fast-paced environment

  • Good communication skills

  • Good organizational skills

Education Minimum Requirement:

  • PhD in biology, pharmacology, medicine, or related fields with 2+ years’ experience, OR, MD degree with 2+ years’ experience, OR MS with 5+ years’ experience, OR BA/BS with 8+ years’ experience.

Required Experience and Skills:

  • Strong writing skills and experience drafting study reports, scientific manuscripts, or scientific documents

  • Strong computer skills, especially MS Word

Preferred Experience and Skills:

  • A good understanding of therapeutic (small molecules, biologics, etc.) and/or vaccine development, including an understanding of the nonclinical aspects, e.g., pharmacology.

  • A good understanding of the content of regulatory filings for nonclinical pharmacology in the context of CTD, IND, IMPD, NDA/BLA/MAA.

  • American Medical Writers Association certification


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 separationpackage, 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

Current Contingent Workers apply HERE

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 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

EEOC GINA Supplement

Pay Transparency Nondiscrimination

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

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:

$113,400.00 – $178,400.00

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.

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: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: 1st – Day

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date:

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.

Requisition ID:R292717