• Leading the development of high-quality and on-time clinical study documents • Clinical document planning, writing, editing/formatting, and performing QC review • Develop documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements • Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments • Ability to independently formulate key messages from clinical study data • Ability to author complex content using knowledge/skills and understanding of processes • Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents • Performing literature-based research to support writing activities

• Is in charge of creating, writing, and coordinating concept documents, protocols, informed consent forms, and clinical study reports according to Sanofi Pasteur document standards, tools, and SOPs. • Is in charge of creating, coordinating, compiling, and editing investigator brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) according to Sanofi Pasteur standards, tools, and SOPs. • Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards, coordinating the medical writing CTD activities (interaction with RA and other functions involved), and providing the CTD supportive activities within the medical writing department. • Participates as a member of the clinical team accountable to the Clinical Team Leader for all project issues (role of referent medical writer). • Is involved in the peer-review and QC cross-check of documents produced by the Medical Writing platform and in the review of documents produced by other departments (such as SAP and CRF). • Contributes to the development of document templates and relevant SOPs. • Represents the platform on committees and working groups within Clinical as requested. • Provides mentoring support to less experienced colleagues and new Company staff members if needed. • Provides project management of medical writing deliverables for a trial or project, including negotiating timelines, and identifying and escalating issues to both the clinical team and the local Head of Medical Writing. • Is in charge of supervising subcontracted medical writing activities if needed. May contribute to the updates of templates, SOPs, and other guides for Medical Writing.

Role Description The Clinical Documentation Specialist coordinates and maintains the elements and requirements of the Clinical Documentation Improvement Program, including staff and physician education, to ensure the highest quality of documentation in support of compliance and accurate representation of the care provided to the patient. - Coordinates and maintains all elements of the Clinical Documentation Improvement Program to meet the goals and objectives of the organization and its stakeholders. - Meets CDI program objectives, goals, and balance scorecard metrics. - Ensures timely, accurate, and complete documentation of clinical information used for measuring and reporting physician and hospital outcomes. - Ensures effective communications with key stakeholders. - Analyzes data and creates reports to meet desired outcomes. - Identifies trends and opportunities for improvement in clinical documentation. - Meets program quality and productivity guidelines and standards. - Collaborates with coding professionals to fully support the needs of clinical code assignment and communicates proficiently with coding professionals to resolve identified discrepancies. - Works effectively with CDI team members to accomplish departmental goals. - Demonstrates continued advancement in professional growth. - Performs duties in compliance with Company’s policies and procedures, including but not limited to those related to HIPAA and compliance. Qualifications - Ability to prioritize and multi-task in a multifaceted environment. - Demonstrate strong organizational skills and be detail oriented. - Demonstrate ability to self-motivate, set goals, and meet deadlines. - Demonstrate mentoring and interpersonal skills. - Demonstrate excellent presentation, verbal, and written communication skills. - Ability to develop and maintain relationships with key business partners by building personal credibility and trust. - Maintains courteous and professional working relationships with employees at all levels of the organization. - Demonstrate successful leadership skills with the use of critical thinking, problem solving, and deductive reasoning required. - Specialized training in advanced computer skills with proficiency in Microsoft Word, Excel, PowerPoint, and Outlook e-mail required. - Additional training in Access database management, Medicare Part A and B programs, DRG assignment, and knowledge of MCC/CC preferred. Requirements - Experience: Bachelor’s degree in healthcare field (e.g., nursing, health information management) OR equivalent combination of education/experience combined required. (One year of education equals one year of experience). - Minimum Experience: Minimum of one to three years’ experience in clinical quality, utilization management, case management, nursing, coding, or a related field. - Preferred Experience: Three to five years’ experience in a Clinical Documentation Improvement Program with previous experience in clinical quality, utilization management, case management, nursing, coding, or related field (e.g., physician) of which a minimum of three years’ experience is in a management or supervisory role. - Education: Bachelor’s degree, with a healthcare related credential. Benefits - Comprehensive benefits package that may include health, dental, and vision coverage. - Voluntary insurance options. - 401(k) plan with employer match. - Professional development opportunities. - Paid time off and holiday pay. - Opportunity to participate in bonus programs, commissions, or other variable incentive plans.

• To write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions) in accordance with sponsors’ and Excelya’s SOPs, guidelines and applicable legislation. • To coordinate cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure the timely collection, review, alignment, and integration of scientific and clinical content required for the development of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs). • To ensure the accuracy, consistency and regulatory compliance of all information, data and references included in the produced publications/documents, maintaining high standards of scientific quality. • To contribute to document quality control (reviewing data accuracy, formatting, appropriateness of language and compliance with industry guidelines). • To mentor and lead less experienced Medical Writers on complex projects, and to support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers. • To liaise with sponsors to negotiate changes where necessary and ensure alignment on deliverables and expectations.