Syneos Health

Clinical Research

• Provide support to clinical study and/or project teams on all relevant statistical matters
• Provide input into study design, protocol development, setup and conduct to ensure data capture supports objectives and planned analyses
• Accountable for statistical deliverables: protocol sections, sample size calculation, randomization specifications, statistical methodology, SAP, data surveillance, statistical analysis results for CSR and appendices (TLGs and tables)
• Utilize external groups (e.g., CROs, DMCs) effectively
• Work with programming team on definitions, documentation, derived variables, and QC plans
• Perform or coordinate production of statistical analyses and review data distributions/properties
• Oversee execution of analyses per SAP, prepare statistical methods, and provide statistical insight for CSR and publications ensuring integrity and regulatory compliance
• Propose and perform exploratory and ad-hoc analyses relevant to study objectives
• Contribute to transparency and disclosure deliverables
• Plan and track study/project activities and timelines
• Ensure productive collaboration with other functions, promoting teamwork, quality, operational efficiency, and innovation

Principal Biostatistician, Medical Affairs

Human Resources

• Handles transactional and operational HR activities across multiple functional areas, including hiring, termination, labor law compliance, contract management, trainee programs, expatriate management, and retirement processes.
• Maintains personnel records and prepares statistical reports on employee demographics and skills inventory.
• Coordinates with external agencies such as government bodies, insurance companies, and unions.
• Oversees the implementation of total rewards programs.
• Manage and resolve complex Tier 3 HR inquiries and issues, delivering high-quality service in alignment with global HR standards and best practices.
• Provide performance guidance and engagement counseling to managers and employees to support a positive, productive, and inclusive work environment.
• Deliver comprehensive employee relations services, including handling performance management processes, creating and monitoring performance improvement plans (PIPs), and conducting thorough workplace investigations.
• Support in-market talent initiatives, including the planning and execution of both small- and large-scale organizational restructurings.
• Collaborate with Regional Governance PSN Team, working closely with a diverse, global/regional team to ensure alignment with organizational goals, direct in-market support and delivery at scale around the world
• Leverage the tiered HR service delivery model by promoting and reinforcing employee and manager self-service tools to enhance the efficiency and effectiveness of HR support.

HR Advisor – Employee Relations

Medical writer

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
• Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
• Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings
• Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
• Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
• Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
• Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
• Mentor and lead less experienced medical writers on complex projects
• Develop deep expertise on key topics in the industry and regulatory requirements
• Work within budget specifications for assigned projects

Senior Medical Writer – Regulatory Submissions

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
• Manage medical writing activities for individual studies and coordinate across departments
• Prepare clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, PSURs, clinical development plans, IND/IDS/NDAs and eCTD submissions, integrated summaries, manuscripts, abstracts, posters, and presentations
• Adhere to regulatory standards including ICH E3, company SOPs, client standards, templates, and style guides
• Coordinate quality and editorial reviews and act as peer reviewer
• Review SAPs and TFL specifications and provide feedback on statistical outputs
• Interact with clients and cross‑functional teams (data management, biostatistics, regulatory, medical affairs)
• Perform online clinical literature searches and comply with copyright requirements
• Identify and resolve issues, provide technical support, training, and consultation
• Mentor and lead less experienced medical writers and develop subject matter expertise
• Work within budget specifications for assigned projects

Senior Medical Writer, CSR, IB, Protocol Drafting

Business Development Rep

• Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
• Translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
• Perform better because of collaboration as one team across business-critical services that support the business.
• Responsible for developing and executing sales, account planning, client relationship building, and cross-functional collaboration to grow assigned markets/accounts.

Executive Director, Business Development

• Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success
• Develop and implement annual sales plans for assigned markets/accounts, including forecasting and objective setting
• Prioritize accounts and territory focus using data-informed insights and manage pipeline and sales progress
• Build and maintain strategic account plans, identify client challenges, and drive account expansion and renewals
• Collaborate with cross-functional teams to co-create customized solutions and advocate for clients
• Educate clients on Syneos Health’s clinical and commercial service capabilities and represent the company externally

Senior Director, Business Development

• Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Reviews SAS annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams.
• Conducts and participates in verification and quality control of project deliverables.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes, and proactively communicates difficulties with timelines to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
• Leads projects involving integrated analyses, attends regulatory agency meetings or respond to questions, as needed.
• Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines.
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs.
• Displays willingness to work with others and assists with projects and initiatives as necessary.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Principal Biostatistician, Safety Surveillance, RWE

Clinical Trial Manager II, FSP

Content Writer

• Manage and supervise medical writing team focusing on narratives and deliverables.
• Ensure quality, completeness, and accuracy of medical writing products.
• Lead cross-functional teams and mentor staff.
• Review statistical analysis plans and tables/figures/listings.
• Contribute to budgeting, forecasting, and departmental SOPs.
• Support business development and client-facing activities.
• Participate in document planning, writing, and assembly.

Manager, Medical Writing – Narratives

Manager

• Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
• Translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
• Clinical Development model brings the customer and the patient to the center of everything.
• Continuously looking for ways to simplify and streamline work to make Syneos Health easier to work with and for.
• Collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals.
• Reward and recognize people by providing valuable benefits and a quality-of-life balance.
• Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed customers’ delivery of therapies to patients.

Site Contracts Manager

Project Manager

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements. • Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement. • Lead project team to ensure quality, timelines and budget management. • Accountable for the financial performance of each project. • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. • Accountable for all project deliverables for each project assigned. • Documentation and Reporting: Responsible for quality and completeness of TMF for assigned projects. • Accountable for maintenance of study information on a variety of databases and systems. • Responsible for study management components of inspection readiness for all aspects of the study conduct. • Oversight for development and implementation of project plans. • Plan, coordinate and present at internal and external meetings. • Prepare project management reports for clients and management. • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. • Business Development: Develops strong relationships with current clients to generate new and/or add-on business for the future. • May participate in bid defense meetings where presented as potential project manager. • Management: May be required to line manage other project management team members and clinical monitoring staff.

Senior Project Manager

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
• Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
• Develops good working relationships with internal and external colleagues.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical protocol amendments; o Clinical study reports; o Patient narratives; o Clinical development plans; o IND submissions and annual reports; o Integrated summary reports; o NDA and (e)CTD submissions; o Investigator brochures, as well as; o Clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
•Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as applicable.
• Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
• Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Principal Medical Writer

Compliance

• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, pre-approval submission packages, for product registration applications, and for post-approval maintenance.
• Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, scope, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
• Prepare training materials and share best practices in the regulatory area, both internally and externally.
• Participate as regulatory support in internal or external project audits.
• Participate as regulatory support on internal cross-functional initiatives.
• Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
• Provide support in oversight to team members in the execution of their project responsibilities.
• Capable of identifying when to ensure line support required to provide additional guidance and direction.
• Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
• The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

Regulatory Consultant CMC

Operations

• Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
• Team Leadership and Supervision
• Supervise and support the Operations Associates in their daily tasks, ensuring timely and accurate completion of product launches, product deliveries (LaunchPad, etc.), and customer service cases.
• Assign and prioritize work for the Operations Associate team based on business needs and deadlines.
• Provide coaching, training, and professional development opportunities for Operations Associates to enhance their skill sets.
• Conduct regular performance check-ins and offer constructive feedback to drive team success.
• Operational Efficiency
• Ensure quality assurance throughout Sales Operations processes by maintaining high data integrity standards, including CRM audits and accurate record maintenance.
• Partner with the Operations Manager to identify and implement process improvements, with a focus on automation and efficiency.
• Monitor inbound web and phone support requests to ensure excellent customer service and prompt response times from the team. Ensure the volume of requests is proportionate to the number of available team members.
• Collaborate with internal teams to facilitate cross-reference reporting using the company's native platform.
• Collaboration and Reporting
• Act as a liaison between the Operations Associate team and the Operations Manager, communicating key updates, challenges, and progress.
• Support the Operations Manager by providing data analysis and insights to drive informed business decisions.
• Assist in the preparation of weekly reports, pipeline accuracy checks, and ad-hoc deliverables.
• Ensure smooth communication with cross-functional teams such as Business Development, Project Management, Call Center, and Advertising to align operational processes with company goals.
• Operate and provide training to Operation Associates on the effective use of website builder, ensuring they are proficient in creating, updating, and maintaining web pages to meet organizational and regulatory standards.
• Continuous Improvement
• Proactively identify areas for improvement in operational processes and propose solutions.
• Encourage knowledge sharing among team members to foster a collaborative and high-performing work environment.
• Support ongoing Salesforce initiatives and collaborate with the Operations Manager and IT teams to optimize CRM functionality.