Principal Medical Writer- Clinical & Regulatory Strategic Communications

Job Description

The Clinical and Regulatory Strategic Communications (CRSC) department within GCTO creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

The Principal Medical Writer, in partnership with a project lead, leverages strategic and scientific expertise to develop, author, edit, and lead the review of accurate, clear, and compliant clinical, regulatory, and/or public‑facing documents, across multiple programs and therapeutic areas, in support of the company portfolio.

In this role, the Principal Medical Writer:

• Is recognized as a subject matter expert in the design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy) and evolving regulatory requirements.

• Is recognized as a strong scientific contributor and collaborator on cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.

• Applies critical thinking, problem solving, and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics.

• Provides program oversight by keeping project leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.

• Demonstrates expertise in medical writing-specific tools and technology platforms.

• Leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate.

• Applies in-depth knowledge of clinical development, relevant regulations, disease areas, and company products. Demonstrates a developing understanding of the pharmaceutical industry beyond clinical research.

• Provides scientific and operational mentorship, coaching and/or project oversight to support other medical writers.

• May manage direct reports including workload, professional development, and performance management.

Qualifications:

• Required: Bachelor’s degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 5 years of relevant medical writing or industry experience.

Required skills & experience:

• Experience managing complex writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.

• Ability to critically evaluate and interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines.

• Demonstrated critical thinking and problem-solving capabilities, with an ability to innovate, influence, and drive change.

• Demonstrated effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making.

• Excellent oral and written communication and presentation skills.

• Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.
• Experience independently preparing a different set of clinical regulatory documents (e.g., protocols, clinical study reports, clinical submission documents) in accordance with regulatory requirements and industry guidelines.

Required Skills:

Clinical Data Management, Clinical Operations, Clinical Study Design, Clinical Study Management, Clinical Trials Operations, Collaborative Leadership, Ethical Standards, Leadership Theories, Medical Studies, Medical Writing, Project Leadership, Project Management Oversight, Project Team Management, Regulatory Compliance, Regulatory Processes, Regulatory Requirements, Stakeholder Alignment

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:

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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.

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The salary range for this role is

$142,400.00 - $224,100.00

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/7/2026

*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.