Job Description

**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 oversight, the Informed Consent Medical Writer: + Demonstrates growing independence managing multiple study-specific informed consent deliverables per company and regulatory requirements, leveraging study protocols, established templates, libraries, glossaries, and risk language. + Acquires and applies 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 understanding of required timelines, protocol details, and study-specific procedures that impact informed consent documents. + Applies a developing understanding of clinical development, study protocols (eg, design, objectives, and study procedures), relevant regulations, disease areas, and company products. + Identifies & proposes solutions to challenges across the informed consent medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics. + Applies developing knowledge of informed consent-specific tools and technology platforms. + Participates in initiatives to improve informed consent processes and standards. **Qualifications** + Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) **Experience and Skills** + 3+ years of relevant medical writing experience. + Experience presenting complex medical concepts in a clear, concise, and health-literate format; awareness of health literacy principles preferred. + Experience preparing a summary of a clinical trial design, objectives and activities for a lay audience per established guidelines and government regulations. + Demonstrated critical thinking and problem-solving capabilities. + Ability to manage projects in a deadline-driven environment, working both independently and collaboratively with cross-functional teams. + Ability to 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). + Strong communication (oral, written, presentation) and project management skills MW20 Researchanddevelopmentgcto \#eligibleforerp 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: EEOC Know Your Rights ( EEOC GINA Supplement​ 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. Learn more about your rights, including under California, Colorado and other US State Acts ( **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 $94,300.00 - $148,500.00 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 . 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 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, Analytical Problem Solving, Business Communications, Clinical Development, Clinical Research, Clinical Study Design, Clinical Trial Documentation, Clinical Trials, Clinical Trials Operations, Critical Thinking, Data Management, Ethical Standards, Health Literacy, Informed Consent, Internal Inspection, Management Process, Manufacturing Compliance, Medical Writing, Microsoft Office, Project Management, Regulatory Compliance, Regulatory Requirements, Regulatory Writing {+ 4 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:** R352067

Job Tags

Holiday work, For contractors, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,

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