MMS

Role Description We are looking for a full-time employee, remotely based within the UK. This position requires proven Project Management experience in support of Biometric and Data deliverables (Data management, Biostatistics, Statistical Programming services). - Understands various cost models and develops budgets for moderate complexity projects. - Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. - Controls project scope via defined PM methodology and processes for change management. - Develops moderate complexity project timelines independently. - Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations. - Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends. - Intermediate excel skills (Hlookup, Vlookup, Pivot Table, etc.). - Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account. - Participates in or leads RFIs/RFPs in collaboration with proposals team. Participates in or leads capabilities meetings - at least 2 annually. - Participates in or leads bid defenses - at least 1 annually. - Proficient in Word, Outlook, PowerPoint. - Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met. - Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000. Qualifications - Bachelor’s Degree required, or relevant work experience. - Minimum of 5 years’ experience in project coordination or project management or similar field required. - Expert knowledge of scientific principles and concepts. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Familiarity with current ISO 9001 and ISO 27001 standards preferred. - Familiarity with 21 CFR Part 11, FDA, and GCP requirements. - Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Requirements - Bachelor’s Degree required, or relevant work experience. - Minimum of 5 years’ experience in project coordination or project management or similar field required. - Expert knowledge of scientific principles and concepts. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Familiarity with current ISO 9001 and ISO 27001 standards preferred. - Familiarity with 21 CFR Part 11, FDA, and GCP requirements. - Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Company Description MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.

Role Description We are looking for a full-time employee, remotely based within South Africa. This position requires proven Project Management experience in support of Biometric and Data deliverables (Data management, Biostatistics, Statistical Programming services). - Understands various cost models and develops budgets for moderate complexity projects. - Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. - Controls project scope via defined PM methodology and processes for change management. - Develops moderate complexity project timelines independently. - Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations. - Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends. - Intermediate excel skills (Hlookup, Vlookup, Pivot Table, etc.). - Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account. - Participates in or leads RFIs/RFPs in collaboration with proposals team. Participates in or leads capabilities meetings - at least 2 annually. - Participates in or leads bid defenses - at least 1 annually. - Proficient in Word, Outlook, PowerPoint. - Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met. - Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000. Qualifications - Bachelor’s Degree required, or relevant work experience. - Minimum of 5 years’ experience in project coordination or project management or similar field required. - Expert knowledge of scientific principles and concepts. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Familiarity with current ISO 9001 and ISO 27001 standards preferred. - Familiarity with 21 CFR Part 11, FDA, and GCP requirements. - Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Requirements - Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

Role Description This role is a project-based consulting opportunity to conduct medical reviewing on an as-needed basis. This is not a full-time position. - Provide medical expertise on development-related or emerging cardiac safety concerns - Responsible for medical monitoring tasks - Provide medical input throughout the development process - Provide medical input into the development and execution of study documents and plans, such as study protocol, IB, SMP, DMP, SAP, Lab manuals, etc. - Provide significant expertise as primary medical reviewer of individual adverse event reports, clinical, and safety documents - Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company - Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations - Responsible for strategies in monitoring and analysis of cumulative safety information - Maintains significant knowledge of global and local regulations and guidance as they pertain to medical review and safety reporting Qualifications - Medical degree required (MD or equivalent) - Specialty in Cardiology or comparable experience in Cardiology - 5 or more years of clinical experience and/or research experience required - Relevant experience in medical monitoring and/or medical reviewer in pharmaceutical industry - Excellent scientific writing skills - Ability to understand clinical data - Proficiency with MS Office applications - Good communication skills - Strong knowledge of current regulatory practices and domestic and international regulations

Role Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Qualifications - Proficient generating tables, listings, and graphs from clinical trial databases using SAS. - Utilizes System Development Life Cycle (SDLC) for programming deliverables. - Proficient in SAS programming, SAS Base, SAS Macros. - Ability to adhere to E-Submission Standards, Guidelines and Regulations. - Mastery of SDTM standards including ability to write specifications. - Proficient in ADaM standards. - Proficient with MS Office applications. - Ability to adhere to ICH, 21CRF Part 11, and ISO 9001:2000 requirements. - Experience with pooling of data sets for submissions. - Experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP. - Member of project team. Requirements - Masters required for all Statistics roles. - Minimum of 3 years’ experience in Statistical Programming or similar field required. - Expert knowledge of scientific principles and concepts. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Familiarity with current ISO 9001 and ISO 27001 standards preferred. - Familiarity with 21 CFR Part 11, FDA, and GCP requirements. - Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Company Description Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn .

Role Description We are recruiting for an Associate Medical Writer to join our South African team. This position is a home-based role out of any location in South Africa. Job Specific Skills - Has basic understanding of regulations and guidance as they pertain to medical writing. - Trained on styles of writing for various document types. - Has understanding of QC process. - Trained on general instructions on process, detailed instructions on MW deliverables and client/MMS processes. - Trained on templates, toolbars and formatting. - Understands MMS and client processes and training; is 100% compliant. - Has basic understanding of impact of updates in related deliverables. - Trained on managing client meetings and CRMs. - Trained and has basic understanding of managing a project from start to finish. - Has basic understanding of identifying and mitigating project risk, including assessing client gaps. - Has basic understanding of handling client feedback. - Can set up QC trackers. Can lead projects with guidance. - Can incorporate straightforward comments. Can format documents. Qualifications - College graduate in scientific, medical, clinical discipline or related field, or related experience, masters or PhD preferred. - 0-2 years of experience in Medical Writing or similar field preferred/required. - Knowledge of scientific principles and concepts. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Familiarity with current ISO 9001 and ISO 27001 standards preferred. - Familiarity with 21 CFR Part 11, FDA, and GCP requirements. - Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Requirements Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

Role Description Senior Biostatistician: - Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams. - Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies. - Review ADAM and TLFs; work with client and programmers to resolve comments. - Strong programming and logic skills (working knowledge of SAS). - Ability to apply drug development knowledge during production of high quality statistical analyses. - Perform sample size calculations for a variety of scenarios and study designs. - Lead projects (all phases and even a program of studies) and smaller submissions, manage client meetings, CRMs, collaborate well with regulatory, PMs and sponsor. - Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutic areas. - Understand the various tools that we work with. - High level knowledge of drug development as it pertains to biostatistics. - Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician. - Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support. - High proficiency with MS Office applications. - Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation. - Provide ICH guideline based input as applicable to statistics. - Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers. Qualifications - College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required. - Minimum of 5 years’ experience in Biostatistics or similar field required. - Expert knowledge of scientific principles and concepts. - High level knowledge of drug development as it pertains to biostatistics; ability to apply drug development knowledge during production of high quality statistical analyses. - Strong SAS programming, SAS base, SAS macro experience. - Thorough knowledge and understanding of clinical data preferred. - Strong experience with data and production of TLGs. - Excellent scientific writing skills. - Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Familiarity with 21 CFR Part 11, FDA, and GCP requirements. - Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Requirements - Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

Role Description Mastery in generating tables, listings, and graphs from clinical trial databases using SAS. - Utilizes System Development Life Cycle (SDLC) for programming deliverables. - Advanced user in SAS programming, SAS Base, and SAS Macros. - Advanced knowledge of E-Submission Standards, Guidelines and Regulations. - Mastery and train on SDTM standards including ability to write specifications. - Advanced knowledge of ADaM standards including supporting specification writing. - Proficient with MS Office applications. - Advance knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements. - Advanced experience with pooling of data sets for submissions. - Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP. - Lead study or small programming project teams. - Independently manages tasks and projects to achieve set objectives. - Provides guidance to more junior level colleagues. - Identifies and suggests opportunities for improvement related to Service and/or Service Line at the project level. - Actively contributes ideas, suggestions and best practices in interactions with the external and internal customers. - Frequently supports Business Development activities and customer kick off meetings. - Experienced professional who knows how to apply theory and put it into practice with in-depth understanding of the professional field. - Independently performs the full range of responsibilities within the service; possesses broad job knowledge. - Analyzes problems/issues of diverse scope and determines solutions. - Proactively stays abreast on external industry and technology developments. - Able to diagnose internal and customer gaps and propose relevant solutions. - Maintains high level of confidentiality related to customer and internal projects. - Exercises high degree of judgment regarding the information that can be disclosed internally and externally. - Solves complex problems; takes a broad perspective to identify solutions. - Produces high quality project deliverables across multiple, high complexity projects with high level of efficiency. - Represent self and company in a professional manner and in line with core company values. - Practice excellent internal and external customer service, communication, and teamwork. - Support objectives and improvement efforts within department and organizationally. - Comply with all applicable policies, procedures, and training requirements. - Additional tasks as assigned by manager. Qualifications - College graduate in computer science or related field required, Masters preferred, or related experience. - 5-9 Years of prior programming experience preferred; interested in expanding knowledge of drug development as it pertains to programming. - Has high level knowledge of drug development as it pertains to clinical programming; has the ability to apply drug development knowledge during production of high quality programs. - Strong hands-on experience with clinical trials and pharmaceutical development. - Strong experience with data and production of TLGs. - Strong programming and logic skills. - Thorough understanding of CDISC standards and HL-7 standards. - Experience in pharmaceutical or CRO industry. - Strong SAS programming, SAS Base, SAS Macro experience. - Thorough knowledge of clinical database structures. - Ability to program data presentations, using programs such as SAS procedures. - Excellent organizational and communication skills.

Role Description MMS is seeking a qualified candidate to maintain a strong understanding of regulations and guidance as they pertain to compliance. The role includes: - Understanding how to plan, prepare, and conduct GxP audits independently. - Supporting clients with the development or refinement of Quality Management Processes or Systems. - Managing project activities related to quality and compliance. - Authoring and managing audit documents independently. - Monitoring vendors and clinical investigator sites to ensure processes are followed and quality is maintained. - Assisting in other duties related to overall compliance within the Quality and Compliance department, as requested. - Willingness to travel up to 30% of the time for audits within the US and internationally as needed. Qualifications - College graduate in scientific, medical, clinical discipline, or related experience; Masters preferred. - Minimum of 7 years’ experience in GCP regulated industry if not a college graduate. - Minimum of 5 to 7 years’ experience in GCP regulated industry (e.g., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor). - Expertise within CROs, scientific and clinical data/terminology, and the drug development process. - Experience with project oversight including document management, vendor qualifications, and training management. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Proficient with applicable regulatory requirements. - Strong technical writing skills. Requirements - College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate. - Minimum of 5 to 7 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor). - Expertise within CROs, scientific and clinical data/terminology, and the drug development process. - Experience with project oversight including but not limited to; document management, vendor qualifications, training management. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Proficient with applicable regulatory requirements. - Must have strong technical writing skills. Benefits

Role Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Responsibilities - Provides advanced input into statistical sections and overall consistency of clinical study protocols. - Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client. - Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality. - Works with programming team to provide definitions for analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs). - Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets. - Works with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the clinical trial. - Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP. - Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements. - Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers. - Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician. - Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol. - Generates and reviews randomization schedules per the protocol and randomization specifications. - Works with the project management group to ensure timelines are appropriate given the scope of the project. - Is familiar with and stays current with the latest industry practices and updated regulatory guidelines. - Communicates competently and independently with client to coordinate the statistical and programming considerations of the project. - Demonstrates strong understanding of ICH guidelines, as applicable to statistics. - Practices good internal and external customer service. Qualifications - Master of Science (in statistics or equivalent) with five (5) plus years relevant work experience or PhD (in statistics or equivalent) with two (2) plus years of relevant work experience. - Strong knowledge of and experience with SAS (SAS Stat, SAS Base, SAS macros, SAS/ODS, SAS/Graph). - Able to be in a hands-on role by digging into data and using SAS to validate datasets and outputs. - Excellent mathematical and problem-solving skills. - Advanced knowledge of the statistical considerations involved in drug development including hands-on experience with clinical trial data. - Strong knowledge of study designs and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis techniques, general imputation methods, common descriptive stats). - Strong familiarity with a variety of clinical data and databases (including EDC systems). - Working knowledge of SDTM/ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets). - At least three (3) years of experience in the pharmaceutical industry. - Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time. - Proficiency with MS Office applications (e.g., Word, PowerPoint, and Excel). - Good interpersonal, oral, and written communication skills. - Self-motivated, hardworking, dependable, and positive team-oriented personality. - Ability to communicate effectively and provide clear directions to Statistical Programmers. Requirements - Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

• Participate in the development, writing, and management of highly technical nonclinical documents • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs) • Lead projects independently with minimal oversight • Lead the writing (structure, content and messaging) of nonclinical documents • Ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity • Ability to author based on highly technical sources • Develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC • Demonstrated ability to lead others to complete complex projects • Complete documents according to sponsor’s format, processes, and according to regulatory guidelines • Effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment • Organizational expert within the nonclinical subject area • Excellent written/oral communication and strong time and project management skills • Attend regular team meetings, lead client meeting and CRMs • Work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development