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About the Role
We are seeking an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group. This role is responsible for generating preclinical reports and submission modules to support development programs, partnering with research and regulatory functions to prepare high-quality scientific and regulatory documents. The successful candidate will manage multiple programs, prioritize timelines, and drive project completion in alignment with business objectives and regulatory milestones.
Responsibilities
- Serve as a central coordinator for generating preclinical reports and regulatory submission modules, managing scope and timeline, and guiding review, approval, and submission processes.
- Conduct extensive preclinical data collection and QC to ensure data integrity in compliance with regulatory requirements.
- Analyze and synthesize nonclinical datasets, develop scientific narratives, and ensure consistency across documents.
- Author, edit, format, and submit pharmacology study reports, integrated pharmacology summaries, and other regulatory documents.
- Ensure all documents meet scientific, regulatory, and company quality standards, and maintain compliance with regulatory guidance and internal 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.
- Support document QC and transfer related to business development & licensing activities.
Requirements
- 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.
- Familiarity with the content of regulatory filings for nonclinical modules (CTD, IND, CTA, IMPD, NDA/BLA/MAA).
- Excellent scientific writing and editing skills for study reports, IB, CTD components, scientific manuscripts, or documents.
- Solid understanding of drug discovery and development processes, pharmacology principles, and standard laboratory operations for 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.
- 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 detail and commitment to quality.
Skills
- Medical Writing
- Pharmacology
- Regulatory Compliance
- Regulatory Documents
- Regulatory Filings
- Regulatory Processes
- Regulatory Research
- Regulatory Submissions
- Scientific Literacy
- Scientific Writing
- Study Reports
- Technical Communication
- Detail-Oriented
- Drug Discovery Process
- Oncology
- Neuroscience
- Immunology
- Cardiovascular-Metabolic
- Infectious Diseases
- Small molecules
- Biologics
- Drug conjugates
- Vaccine development
- AI-enabled data retrieval
- AI-enabled QC
- AI-enabled scientific writing tools
Location
- Rahway, NJ, USA
Work Type
- Hybrid
- Regular
Experience Level
- 7+ years (Bachelor's)
- 4+ years (Master's)
- 1+ year (Ph.D.)
Education Level
- Bachelor's Degree
- Master's Degree
- Ph.D.
Salary/Compensations
- $131,400.00 - $206,800.00
Benefits
- 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
- Annual bonus
- Long-term incentive
About the Company
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.
- 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.
Equal Opportunity
- 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.
- We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
- 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.