Job Description The Medical Writer is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With oversight, the Medical Writer: * Demonstrates growing competence and independence in preparing clinical regulatory documents (e.g., clinical study reports, participant narratives, investigator’s brochures) per company and regulatory requirements. * Acquires and applies an understanding of medical writing responsibilities, including document planning and authoring, and interpretation of data. * Is a contributing member on document\-specific cross\-functional teams and demonstrates an understanding of team and project leadership responsibilities. * Applies developing knowledge of clinical development, relevant regulations, disease areas, and company products. * Identifies \& proposes solutions to challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics. * Applies developing knowledge of medical writing\-specific tools and technology platforms. * Participates in initiatives to improve medical writing processes and standards. **Qualifications, Skills \& Experience** * Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine). * Bachelor’s degree with 3\+ years, master’s degree with 2\+ years, or doctorate degree with 1\+ years of relevant career experience. * Experience preparing a subset of clinical regulatory documents (e.g., clinical study report shell or appendices, investigator’s brochure updates, participant narratives) and interpreting clinical data per regulatory requirements and industry guidelines. * Demonstrated critical thinking and problem\-solving capabilities. * Experience managing projects and working on cross\-functional teams. * Strong oral and written communication and presentation skills. * Technical expertise in typical office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint). \#LI\-DNI **Required Skills:** Clinical Data Interpretation, Clinical Development, Clinical Trials, Clinical Trials Operations, Data Management, Medical Writing**Preferred Skills:** Current Employees apply HERE Current Contingent Workers apply HERE **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:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Hybrid**Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 11/6/2025* **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:**R372031