• Overseeing the implementation and execution of home visits as outlined in the clinical trial protocol • Collaborating with clients, internal departments, and external vendors • Developing study-specific plans, training materials, and timelines • Mentoring, guiding, and supporting junior team members • Ensuring compliance with local regulations and laws

• Collaborate with a multidisciplinary team of researchers to create and execute project work plans and schedules, using industry-standard applications (e.g., Microsoft Project, Smartsheet) • Create and track project timelines, deliverables, and calendars • Manage consultant agreements and subcontracts • Write and submit reports as required by the client • Maintain a strong client focus • Review and understand project budgets and financial reports and provide financial guidance • Demonstrate an eye for innovation (e.g., exploring/evaluating existing and new technologies) in day-to-day research activities • Foster communication and information dissemination internally within project and business operations teams and externally with collaborators and clients • Maintain awareness of best practices in use with RTI and utilize those best practices in conducting project work • Develop an understanding and appreciation of client needs by interfacing with clients on projects and proposals • Work independently to efficiently manage multiple and overlapping timelines and deliverables • Train staff on processes and protocols

About Servier Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision. Role Summary The Sr Manager, Medical Writing will lead the development of high-quality, compliant English-language non-clinical, clinical, and regulatory documents within the Medical Writing department at Servier Pharmaceuticals US. This role will report into the Director, Medical Writing. Responsibilities include serving as lead author of regulatory and scientific documents, managing the collection of content from cross-functional teams ensuring compliance with internal and external standards, mentoring junior writers, overseeing vendor activities, and acting as the Medical Writing point of contact for an assigned drug development franchise. Documents include, but are not limited to, clinical study reports, protocols, summaries/overviews, investigator’s brochures, scientific publications, clinical sections of investigational new drug applications, contributions to agency response documents, and other global regulatory submission materials. Primary Responsibilities - Serve as the main medical writing contact on study teams ensuring accuracy, consistency, and regulatory compliance in a variety of clinical regulatory documents as outlined above - Author, edit, and manage project deliverables, including timeline development, project management, and active participation on cross-functional project teams - Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents meeting all applicable regulations, standards, and guidelines, including ICH - Prepare responses to questions from regulatory agencies; write briefing packages, other strategic regulatory documents such as accelerated review applications, and assist with materials for presentations at agency meetings and advisory committee meetings as needed - Mentor and manage the work of junior writers as needed - Manage the work and deliverables of contract/vendor writers, as needed - Promote continuous improvement by influencing cross-functional practices to enhance quality, compliance, and efficiency - Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs Education and Required Skills - Bachelor’s degree in relevant scientific/clinical/regulatory field required with a minimum of 7 years of Medical Writing experience; Advanced degree in a relevant scientific/clinical/regulatory field preferred - Experience as a lead writer/medical writing point of contact for marketing applications (NDA/BLA) - Strong project management skills with the ability to manage multiple projects with competing priorities; proficiency with MS Project preferred - Excellent verbal and written communication skills, with the ability to collaborate effectively in a global team environment and build strong cross-functional relationships - Exceptional organizational skills, attention to detail, and ability to work independently with minimal supervision - Ability to adapt to changing priorities and exercise sound judgment in decision-making - Technical proficiency with authoring software such as MS Word and End Note; experience with abbreviation managers/QC tool is desirable - Experience partnering with CROs to ensure adherence to best practices and evaluating outsourcing strategies - Global regulatory submission experience - Familiarity with GCP and ICH guidelines Desirable: - History of successful preparation and submission of a major regulatory marketing application - Experience with authoring/management of clinical and non-clinical documents for drug development Travel and Location - Some domestic and international travel may be required - This role is 100% remote Job Description Candidate Profile Servier’s Commitment Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Salary Range The salary range for this role is $157,000-180,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).

Where You’ll Work Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation’s largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has more than 157,000 employees, 45,000 nurses and 25,000 physicians and advanced practice providers across 24 states and contributes more than $4.2 billion annually in charity care, community benefits and unreimbursed government programs. Together with our patients, physicians, partners, and communities, we are creating a more just, equitable, and innovative healthcare delivery system. Job Summary and Responsibilities As a Planning Design Construction Project Coordinator, you will provide assistance for design and construction related activities for capital projects as assigned.Every day, this position assists the Project Team(s) to affect the timely and cost-effective outcome of capital construction projects as it relates to financial reporting and administration, project team communications, purchase orders, project documentation, and reporting. You will report directly to either a Program Director, Area Director, or Project Director.To be successful in your role, you will meticulously assist the Project Team(s) in planning, design, and construction activities for capital projects, ensuring timely and cost-effective outcomes. You will demonstrate exceptional organizational skills in managing financial reporting, project documentation, and communications, thereby significantly contributing to the successful execution of capital construction projects. - Organizes, attends and participates in project team meetings including preparing agendas, taking meeting minutes and tracking issue identification and resolution. - Develops project reporting and indicates red flags for scope and budget issues. - Assists with the setup of capital and expense budgets including coordination of CIP accounts. - Assists with ongoing budget management. - Manages the purchase order requisition protocols for Project Delivery. - Manages project status within the project management information system. Job Requirements - Associates Other and 1-3 years minimum of experience as a Project Coordinator,healthcare facilities management, and/or project management