Senior Specialist, Nonclinical Medical Writing

Merck & Co.; South San Francisco (CA); Hybrid; USD 131,000 - 207,000; Full time

Benefits offered by this job

Hybrid work arrangement

Medical, dental, vision insurance

401(k) retirement benefits

Job summary

Merck & Co. is seeking an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. The role focuses on generating preclinical reports and submission modules to support development programs, with collaboration across research and regulatory functions.

The successful candidate will manage multiple programs, prioritize timelines, and ensure high-quality regulatory documents for CTD, IND, NDA/BLA/MAA submissions, while contributing to templates and adopting new AI tools.

Qualifications

• Bachelor's (7+ years), Master's (4+ years) or Ph.D. (1+ year) in biology, pharmacology or related scientific disciplines with relevant experience in medical writing and regulatory submission in a pharmaceutical or biotech setting.
• Familiar with regulatory filings for nonclinical modules in CTD, IND, CTA, IMPD, NDA/BLA/MAA.
• Excellent scientific writing and editing skills for study reports, IB, CTD components, and scientific manuscripts.
• Strong understanding of drug discovery and development processes and standard lab operations.
• Hands on experience supporting nonclinical drug discovery and early development programs.
• Strong project management and ability to balance stakeholders and timelines.

Responsibilities

• Serve as a central coordinator for generating preclinical reports and regulatory submission modules and manage timelines with internal partners.
• Conduct extensive preclinical data collection and QC to ensure data integrity and regulatory compliance.
• Analyze and synthesize nonclinical datasets and develop scientific narratives across pharmacology and translational findings.
• Author, edit, format, and submit pharmacology study reports and CTD modules.
• Ensure documents meet regulatory standards and company quality practices.
• Contribute to writing templates, best practices, and standards.
• Evaluate and adopt new digital and AI tools to improve efficiency and quality.
• Support document QC and transfer for business development and licensing activities.

Skills

Regulatory writing

Scientific writing

Regulatory submissions

Pharmacology

Nonclinical data analysis

Project management

Microsoft Office

Attention to detail

Education

Bachelor's degree in biology/pharmacology or related disciplines

Master's degree in biology/pharmacology or related disciplines

PhD in biology/pharmacology or related disciplines

Tools

Microsoft Office

Document management software

Job description

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

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.

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

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.

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:

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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.

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

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

Requisition ID: R413595