Senior Medical Writer, Promotional Review

Job Description:

• Serve as primary author for routine documents such as clinical study reports and study protocols
• Summarize data from clinical studies
• Research, write, or edit complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs
• Review routine documents prepared by junior team members
• Provide training and mentorship to junior writers and program managers
• Support document preparation, software use, document types, regulatory requirements, and therapeutic area knowledge
• Ensure compliance with quality processes and requirements for assigned documents
• Develop best practices, methods, and techniques for optimal results, including client-specific processes
• Assist with program management activities, including timelines, budgets, forecasts, and contract modifications
• Identify and resolve out-of-scope activities
• Represent the department at project launch, review, and project team meetings
• Collaborate with internal and external clients to enable effective communication and operational excellence

Requirements:

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
• 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
• Excellent data interpretation and medical writing skills
• Grammatical, editorial, and proofreading skills
• Strong project management skills
• Excellent interpersonal, problem-solving, negotiation, oral and written communication, and presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, or communications
• Great judgment and decision-making skills
• Excellent computer skills and proficiency with client templates
• Good knowledge of document management systems and relevant applications such as Excel and Outlook
• Occasional ability to drive to site locations and travel domestically and internationally

Benefits:

• Variable annual bonus based on company, team, and/or individual performance results
• National medical and dental plans
• National vision plan
• Health incentive programs
• Employee assistance and family support programs
• Commuter benefits
• Tuition reimbursement
• At least 120 hours paid time off (PTO)
• 10 paid holidays annually
• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
• Accident and life insurance
• Short- and long-term disability
• 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) with company stock discount