Sr. Informed Consent Medical Writer

Job Description

The Medical Writing & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance with public disclosure of clinical trials and their results. The Senior Informed Consent Medical Writer is responsible for developing informed consent deliverables per company process and standards, ensuring compliance with internal policy, regulatory requirements, and health literacy principles.

With minimal oversight, the Senior Informed Consent Medical Writer:

• Demonstrates independence in managing multiple study-specific informed consent deliverables per company and regulatory requirements, leveraging study protocols, established templates, libraries, glossaries, and risk language.
• Applies an in-depth knowledge of informed consent medical writing responsibilities, including design, planning, writing, editing, and review of accurate, clear, high-quality documents that reflect the principles of health literacy
• Collaborates with protocol authors and clinical teams to ensure comprehensive understanding of required timelines, protocol details, and study-specific procedures that impact informed consent documents.
• Applies understanding of clinical development, study protocols (eg, design, objectives, and study procedures), relevant regulations, disease areas, and company products.
• Applies critical thinking, problem solving, and negotiation skills to identify innovative solutions to challenges across the informed consent medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.
• Applies knowledge of informed consent-specific tools and technology platforms.
• Participates in or leads initiatives to improve informed consent processes and standards
• May participate in orientation and coaching of junior team members or contract writers.

Qualifications

• Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine)

Experience and Skills

• 5+ years of relevant medical writing experience
• Demonstrated experience presenting complex medical concepts in a clear, concise, and health-literate format; strong knowledge of health literacy principles preferred.
• Ability to prepare, with minimal oversight, a summary of a clinical trial design, objectives and activities for a lay audience per established guidelines and government regulations.
• Ability to manage multiple projects in a deadline-driven environment, working both independently and collaboratively with cross-functional teams.
• Demonstrated critical thinking and problem-solving capabilities.
• Ability to meticulously review own work to ensure document quality (eg, accuracy, completeness, reading level, grammar, and alignment with document requirements)
• Technical expertise in office applications (e.g., Microsoft Office Suite, Adobe Acrobat) and shared document systems (e.g., SharePoint); familiarity with medical writing-specific tools / technology platforms preferred.
• Strong communication (oral, written, presentation) and project management skills.

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US and Puerto Rico Residents Only:

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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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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
$114,700.00 - $180,500.00

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:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Adaptability, Adaptability, Adobe Acrobat, Clinical Data, Clinical Development, Clinical Operations, Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance, Clinical Trial Management, Critical Thinking, Data Analysis, Early Clinical Development, Ethical Standards, Health Literacy, ICH GCP Guidelines, Informed Consent, Management Process, Manufacturing Compliance, Medical Writing, Motivation Management, Multi-Management, Project Management, Regulatory Compliance {+ 3 more}

Preferred Skills:

Job Posting End Date:
06/20/2025
*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:R352056