Role Description We are seeking a Senior Regulatory Medical Writer to provide fractional, on-demand support for regulatory submission activities. This role focuses on independently updating and finalizing regulatory documents to support ongoing agency interactions and submission deliverables, working alongside internal and contract writers. - Independently update, revise, and finalize regulatory documents, including protocol and IB - Support preparation and maintenance of protocol amendments, submission support documents, and related deliverables within Common Technical Document (CTD Modules 2–5) across the submission lifecycle (responses, amendments, briefing packages) - Ensure scientific accuracy, clarity, consistency, and compliance across all regulatory documents - Collaborate with internal teams and contract writers to ensure timely delivery aligned with regulatory and quality standards - Support intermittent workload demands (~10–15 hours/week during active project periods) Qualifications - Regulatory medical writing experience supporting IND, CTA, NDA, and/or BLA submissions - Strong familiarity with Common Technical Document (CTD) structure and regulatory submission lifecycle (e.g., responses, amendments, briefing packages) - Ability to work independently with minimal oversight in a fast-paced, cross-functional environment - Strong attention to detail with demonstrated ability to ensure scientific and regulatory quality standards - Proven collaboration experience with regulatory, clinical, and medical writing teams

• Providing improvement in the overall quality and completeness of medical record documentation • Obtain appropriate clinical documentation through extensive interaction with physicians, nursing staff, other patient caregivers, and coding staff • Ensure proper reimbursement is received for the level of service rendered to patients • Educate members of the organization on documentation guidelines and improvement efforts

• Oversee strategies and planning for the CDI Program • Promote effective review of physician documentation • Collaborate with interdisciplinary teams • Provide ongoing Clinical Documentation management program education • Develop and manage departmental budgets

Role Description Identifies documentation problem areas and creates audits directed at monitoring performance improvement in these areas. Obtain pre-certification for clinical areas and any home care needs. Provides assistance with pre-certification for inpatients that require testing as outpatients. Responsibilities - Studies existing agency policies and interviews agency personnel to evaluate effectiveness of quality improvement programs. - Facilitates all policies and procedures applicable to documentation process. - Develops educational materials to educate team members. - Compiles statistical data and creates reports summarizing audit findings as requested. - Coordinate initiation of authorization for testing for inpatients and obtain authorization for transport services for patients being transferred to another facility or home. Qualifications - High School Diploma or GED - Associate's Degree (preferred) - Licensed Practical Nurse (preferred) - RN (preferred) Requirements - Experience: Less than 2 years - Supervisor Experience: No Experience Benefits - Comprehensive medical, dental, vision, life insurance, and legal services available first day of the month after hire date - Disability insurance paid for by BJC - Annual 4% BJC Automatic Retirement Contribution - 401(k) plan with BJC match - Tuition Assistance available on first day - BJC Institute for Learning and Development - Health Care and Dependent Care Flexible Spending Accounts - Paid Time Off benefit combines vacation, sick days, holidays and personal time - Adoption assistance