ResearchEd

• Author, review regulatory & other medical writing deliverables independently or with other Sr Medical Writer • Support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed • Authoring & review of patient narratives, CSRs, Protocol, IB, & other regulatory submission documents • Independent authoring and review of manuscripts, abstracts, posters, evidence synthesis projects and other techno-commercial documents • Undertake quality control of the aforementioned deliverables • Showcase flexibility in terms of timelines and writing style based on client needs and therapeutic area requirements across various domains.

• Author and review regulatory & other medical writing deliverables independently • Support in building technical & functional expertise within the group • Contribute/support other writers for manuscripts, slide sets, abstracts, posters, and other techno-commercial documents • Authoring & reviewer of CSRs, Protocol, IB, Briefing books & other regulatory submission documents for US FDA, EMEA and rest of the world • Work with data analysts and statisticians on Real world and evidence generation projects • Undertake quality control (QC, scientific reviews and/or proofreading of deliverables) • Conduct client/KOL interactions, kickoff meetings, and teleconferences • Act as project lead/delivery lead for assigned client • Support innovation initiatives including automation and process improvement • Conduct robust training programs for the team

• Review, understand, and assess clinical data before it is reviewed by Medical/Client. • Communicate and present the relevant trends and findings of the clinical review to the Study Team and the Client. • Ensure that the clinical database and regulatory projects maintain the highest level of integrity. • Collaborate with Client, subcontractors, and Study Team members to meet project timelines and Client expectations for clinical data review. • Review CRFs, data quality review plans, and other clinical study reports as needed. • Propose methods to improve collaboration, efficiency, and excellence in data-related review deliverables to the Chief Scientific/Medical Officer, Clinical Operations and Biometry. • Partner with Study Team in the development of data review plans for individual clinical studies. • Provide continuous review and interpret relevant clinical data, applying clinical expertise to derive meaningful insights. • Analyze and track potential safety events within a given trial and across trials for assigned programs. • Contribute to discussions with Study Team and/or Client regarding modifications in the study and/or strategy based on clinical review.

• Oversee, lead, manage and provide technical expertise within the assigned projects. • Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects/programs. • Ensure appropriate resources are allocated to complete all DM activities on time and budget. • Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs). • Write external vendor reconciliation specifications for programming reconciliation outputs. • Oversee data cleaning activities. • Produce metrics to monitor progress of trial activities. • Ensure all database lock activities are completed on time. • Represent WorldWide DM at both internal and external study meeting calls. • Monitor project scope, budgets and risks and alert DM Management of any concerns. • Liaise with DM Management regularly to discuss progress and issues outstanding. • Collaborate with internal Worldwide departments working on the same project. • Provide training, support and mentorship to other members of the DM department.

• Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs • Responsible for timely communications to the sponsor on all aspects of the study with a priority on communicating any patient safety issues • Manage study vendors, patient enrollment and liaise with investigators and study sites • Continually look for methods to improve the overall collaboration, efficiency, and excellence with which the deliverables are achieved • Accountable for the overall integration and communication of the study parameters to all stakeholders/partners

• Review, understand, and assess clinical data before it is reviewed by Medical/Client. • Communicate and present the relevant trends and findings of the clinical review to the Study Team and the Client. • Ensure that the clinical database and regulatory projects maintain the highest level of integrity. • Collaborate with the Client, subcontractors, and Catalyst assigned Study Team members to meet project timelines and Client expectations for the clinical data review. • Assist in the review of CRFs, data quality review plans, and other clinical study reports. • Propose methods to improve collaboration, efficiency, and excellence in data-related review deliverables.

• Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs • Accountable for the overall integration and communication of the study parameters to all stakeholders/partners • Lead cross-functional teams while understanding and managing client expectations • Manage study vendors, patient enrollment and liaise with investigators and study sites

• Provide executive oversight on multiple clinical research projects and client relationships. • Provide senior management support for broad-based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. • Provide advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department. • Represent the department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, bid defense meetings, and be on the podium at industry events. • Set strategy, develop, lead, and oversee the global department. • Develop and track metrics on productivity and quality, and create strategies and best practices. • Hire, supervise, and mentor biostatistics and programming leaders to effectively manage projects and staff. • Develop and maintain Standard Operating Procedures and other departmental processes and procedures in accordance with guidelines and regulations to ensure quality deliverables. • Drive commercial growth for the business and partner with commercial colleagues effectively. • Provide strategic input to technology for current and future state. • Develop study-specific bids that demonstrate an understanding of each client’s needs in a creative, innovative, efficient, and effective manner. • Oversee operational execution of biostatistics and programming activities within the scope of the contract. • Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients. • Act as a point of escalation as needed. • Provide financial oversight for the Biostatistics and Programming department. • Develop and oversee departmental staff (activities to include interviewing, terminations, promotions, training, personnel growth and retention plans, performance appraisals, goal setting, and salary adjustments). • Supervise and mentor reporting staff in tasks and activities to develop the team structure and enhance departmental and project performance.

• Set strategy, develop, lead, and oversee global data management department. • Develop and track metrics on productivity and quality, and create strategies and best practices. • Hire, supervise, and mentor data management leaders to effectively manage projects and staff. • Develop and maintain Standard Operating Procedures and other departmental processes and procedures in accordance with guidelines and regulations to ensure quality deliverables. • Provide strategic input to business development activities, such as capabilities/bid defense presentations and Requests for Proposals (RFP’s). • Provide strategic input to technology for current and future state. • Develop study-specific bids that demonstrate an understanding of each client’s needs in a creative, innovative, efficient, and effective manner. • Oversee operational execution of data management activities within the scope of the contract. • Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients. • Act as a point of escalation as needed. • Provide financial oversight for the Data Management department. • Develop and track metrics on productivity and quality, and create strategies and best practices. • Develop and oversee departmental staff (activities to include interviewing, terminations, promotions, training, personnel growth and retention plans, performance appraisals, goal setting, and salary adjustments). • Supervise and mentor reporting staff in tasks and activities to develop the team structure and enhance departmental and project performance. • Represent the department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, bid defense meetings, and be on the podium at industry events. • Review and approve non-billable travel requests for the data management team and maintain department utilization. • Act as a data champion within the company.