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. facing documents, across multiple programs and therapeutic areas, in support of the company portfolio. 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 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. 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 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. clinicaltrialjobs 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. Requirements 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. 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. 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 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. 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 Job Posting End Date 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 R418208 #J-18808-Ljbffr Merck