Senior Specialist, Nonclinical Medical Writing

Job Description

We are seeking an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group responsible for the generation of preclinical reports and submission modules to support development programs ranging from FIH to global marketing applications. This individual will partner with various research and regulatory functions to prepare high-quality scientific and regulatory documents that enable the advancement of therapeutic candidates across multiple disease areas and modalities. The successful candidate will independently manage multiple programs and document deliverables in parallel, effectively prioritize competing timelines, and drive project completion in alignment with key business objectives and regulatory milestones.

Key responsibilities:

Serve as a central coordinator for generating preclinical reports and regulatory submission modules, manage the overall scope and timeline, and guide the internal review/approval and submission processes, in collaboration with various research and regulatory functions.

Conduct extensive preclinical data collection and QC to ensure the integrity of data assembly in compliance with regulatory requirements

Analyze and synthesize nonclinical datasets, develop scientific narratives that integrate pharmacology, efficacy, and translational findings, and ensure consistency across documents.

Author, edit, format, and submit pharmacology study reports, integrated pharmacology summaries, and other regulatory documents to internal documentation and filing system.

Ensure all documents meet scientific, regulatory, and company quality standards, and maintain compliance with regulatory guidance and internal document management practices.

Contribute to the development of writing templates, best practices, guidelines, and standards.

Participate in the evaluation and adoption of new digital and AI tools to improve efficiency, quality, and scalability of scientific writing and document preparation.

Support document QC and transfer related to business development & licensing activities, in collaboration with internal and external partners

QUALIFICATIONS:

Education:

Bachelor's (with 7+ years), Master's (with 4+ years) or Ph.D. (with 1+ year) in biology, pharmacology or related scientific disciplines with relevant experience in medical writing and regulatory submission in a pharmaceutical or biotech setting.

Required Experience and Skills:

Familiar with the content of regulatory filings for nonclinical modules in the context of CTD, IND, CTA, IMPD, NDA/BLA/MAA.

Excellent scientific writing and editing skills for generating high quality study reports, IB, CTD components (Module 2 Nonclinical summaries), as well as scientific manuscripts or documents.

Solid understanding of the drug discovery and development processes, pharmacology principles, as well as standard laboratory operation for in vitro and in vivo data generation/collection.

Hands on experience supporting nonclinical drug discovery and early development programs.

Strong project management and organizational skills, with demonstrated ability to work with different stakeholders and balance competing priorities and evolving timelines in a fast-paced environment.

Strong computer skills, proficiency with Microsoft Office, data graphing and visualization tools, and document management software.

Strategic thinking and analytical skills, clear written and verbal communication.

Excellent attention to details and commitment to quality.

Preferred Experience and Skills:

Familiarity with therapeutic areas such as oncology, neuroscience, immunology, cardiovascular-metabolic, or infectious diseases.

Working knowledge of different therapeutic modalities (small molecules, biologics, drug conjugates, etc.) and/or vaccine development.

Experience with AI-enabled data retrieval, QC, and scientific writing tools.

American Medical Writers Association certificate.

#EligibleforERP

Required Skills:

Detail-Oriented, Drug Discovery Process, Medical Writing, Pharmacology, Regulatory Compliance, Regulatory Documents, Regulatory Filings, Regulatory Processes, Regulatory Research, Regulatory Submissions, Scientific Literacy, Scientific Writing, Study Reports, Technical Communication

Preferred Skills:

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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

The salary range for this role is

$131,400.00 - $206,800.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:  We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:  We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

09/30/2026 *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.

Requisition ID:R413595