Job Description
The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trials 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.
The Health Literacy Medical Writer, in collaboration with a project lead, develops, authors, and leads the review of accurate, clear, and compliant clinical, regulatory, and/or publicfacing documents in support of the company portfolio.
The Health Literacy Medical Writer:
Acquires and applies knowledge and understanding of medical writing responsibilities, including 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).
Demonstrates growing competence and independence in preparing clinical regulatory (e.g., clinical study reports, participant narratives, investigatorf9s brochures) and/or public-facing (e.g., clinical trial registration and results postings, plain language summaries, informed consent forms) documents per company and evolving regulatory requirements.
Is a contributing member on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities. Collaborates and negotiates with internal and external stakeholders while planning, authoring, and leading the documents through review and final approval.
Identifies & proposes solutions to challenges across the scope of work (e.g., documents, content, processes, timelines, tools). Keeps Project Leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.
Applies developing knowledge of clinical development, relevant regulations, disease areas, and company products.
Applies developing knowledge of medical writing-specific tools and technology platforms.
Participates in initiatives to improve medical writing processes and standards.
Qualifications:
Required: Bachelorf9s degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 2 years of relevant industry experience.
Required skills & experience
Knowledge of the principles of clinical research, clinical trial design, and fundamental statistics.
Strong attention to detail, analytical/logical thinking skills, ability to critically evaluate and interpret data, and problem-solving capabilities.
Ability to manage multiple projects in a deadline-driven environment, working both independently and collaboratively within cross-functional teams.
Strong oral and written communication, interpersonal, and presentation skills in order to interact effectively and tactfully with stakeholders.
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.
Preferred skills & experience for Health Literacy Writer:
Experience in plain language authoring or communication, such as patient- or public-facing materials, informed consents, plain language summaries, or other health-literate clinical research materials.
Understanding of 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
clinicaltrialjobs
EligibleforERP
Required Skills:
Ability to Coordinate, Ability to Coordinate, Adaptability, Analytical Problem Solving, Business Software Applications, Clinical Research, Clinical Study Design, Clinical Trials, Clinical Trials Operations, Cross-Functional Project Management, Data Management, Deductive Reasoning, Ethical Standards, Evaluate Information, File Sharing, Knowledge Sharing, Logical Thinking, Medical Writing, Progress Monitoring, Project Leadership, Project Management, Project Management Leadership, Project Team Management, Project Tracking, Regulatory Compliance {+ 8 more}
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
US and Puerto Rico Residents Only:
The salary range for this role is
$96,200.00 - $151,400.00
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 employeef9s 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 .
You can apply for this role through (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 Angelesu2019 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:
Not Indicated
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 BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
