Principal Medical Writer

Job Description The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO) 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. Principal Medical Writer Overview The Principal Medical Writer, in partnership with a project lead, leverages strategic and scientific expertise to develop, author, edit, and lead the review of accurate, clear, and compliant clinical, regulatory, and/or public-facing documents, across multiple programs and therapeutic areas, in support of the company portfolio. In this role, the Principal Medical Writer: Is recognized as a subject matter expert in the 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) and evolving regulatory requirements Is recognized as a strong scientific contributor and collaborator on cross-functional teams and demonstrates an understanding of team and project leadership responsibilities Applies critical thinking, problem solving, and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics Provides program oversight by keeping project leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance Demonstrates expertise in medical writing-specific tools and technology platforms Leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate Applies in-depth knowledge of clinical development, relevant regulations, disease areas, and company products. Demonstrates a developing understanding of the pharmaceutical industry beyond clinical research Provides scientific and operational mentorship, coaching and/or project oversight to support other medical writers May manage direct reports including workload, professional development, and performance management Qualifications Required: Bachelor's degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) 5+ years of relevant medical writing or industry experience Required skills & experience Experience managing complex writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members Ability to critically evaluate and interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines Demonstrated critical thinking and problem-solving capabilities, with an ability to innovate, influence, and drive change Demonstrated effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making Excellent oral and written communication and presentation skills Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology Preferred skills & experience Clinical and Regulatory Medical Writer (MW) Experience independently preparing a various set of clinical regulatory documents (e.g., protocols, clinical study reports, clinical submission documents) in accordance with regulatory requirements and industry guidelines. Required Skills: Adaptability Clinical Studies Clinical Trials Operations Data Analysis Good Clinical Practice (GCP) Health Literacy Medical Writing Project Management Regulatory Compliance Stakeholder Alignment Standard Operating Procedure (SOP) Strategic Thinking Preferred Skills: Clinical Trials Leadership Regulatory Submissions Technical Knowledge 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 Learn more about your rights, including under California, Colorado and other US State Acts 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 salary range for this role is $142,400.00 - $224,100.00 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. 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 . 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): N/A #J-18808-Ljbffr