Senior Medical Writer - Health Literacy

Job Description

The Medical Writing and Disclosure (MWD) department within Global Clinical Trial Operations 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.

In partnership with the medical writing project lead, the Senior Medical Writer leads the preparation and execution of clinical regulatory documents and public-facing documents across multiple programs and therapeutic areas in support of the company portfolio.

In this role, the Senior Medical Writer:

• Demonstrates independence in preparing clinical regulatory (e.g., protocols, clinical study reports, participant narratives, investigator's brochures) and/or public-facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) documents per company and evolving regulatory requirements.
• Applies an in-depth knowledge and understanding of 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).
• Is a scientific contributor and collaborator on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.
• Applies emerging critical thinking, problem solving, and negotiation skills to implement solutions to challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics. Keeps medical writing project lead and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.
• Applies knowledge of medical writing-specific tools and technology platforms.
• Participates in or leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate.
• Applies knowledge of clinical development, relevant regulations, disease areas, and company products.
• May help with other departmental needs, such as orientation of new team members or mentoring less experienced writers.
• May manage direct reports, including workload, professional development, and performance management.

Qualifications

• Bachelor's degree or higher in a scientific discipline (e.g., life sciences, pharmacy, medicine).
• At least 3 years of plain language medical writing or relevant industry experience.

Required skills & experience

• Experience managing multiple writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
• Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision.
• Demonstrated critical thinking and problem-solving capabilities.
• Experience with conflict resolution and negotiation in cross-functional teams.
• Ability to adapt to changing project needs and unexpected workload demands to help team succeed.
• Strong oral and written communication and presentation skills.
• Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.
• Experience and proficiency in independent plain language authoring such as patient- or public-facing materials, informed consents, plain language summaries, or other health-literate clinical research materials.
• Experience independently applying health literacy principles and best practices, such as translating scientific content into easy-to-understand text using health literacy and numeracy principles and sensitivity to the needs of audiences across cultures and communities.
• Demonstrated leadership in enhancing health literacy best practices and processes

Preferred skills and experience:

• Background in medical writing, authoring clinical regulatory documents (e.g., clinical study reports, protocols).

clinicaltrialjobs

EligibleforER

Required Skills:
Adaptability, Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Communication, Data Analysis, Ethical Standards, ICH GCP Guidelines, Medical Writing, Microsoft Office, Motivation Management, Regulatory Compliance, Regulatory Documents, Scientific Publications, Team Management

Preferred Skills:

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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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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, Monday - 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".

The salary range for this role is
$117,000.00 - $184,200.00

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:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Job Posting End Date:
01/30/2026
*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:R382720