MMS

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 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

• Develop intellectual property and assets to support the design and analysis of clinical trials, precision medicine and real-world data analytics. • Address the emerging analytics needs of the Industry with biostatistics services, bespoke algorithms and proprietary trial simulation software KerusCloud. • Assist customers with their study design focusing on simulation with KerusCloud. • Prepare study protocols and develop Statistical Analysis Plans and Reports. • Summarize, analyze and visualize study data using statistical methods, delivering results to agreed timelines. • Provide statistical consultancy support to sponsors across clinical development, overseeing third-party deliverables. • Maintain knowledge of relevant research techniques and participate in continuous professional development. • Support pre-sales discussions to understand client needs, contributing to technical solutions and estimates. • Collaborate with Product Development team on statistical aspects of KerusCloud.

• Lead the full life-cycle of KerusCloud support and statistical services • Assist customers with their study design, focusing on simulation with KerusCloud • Prepare study protocols and develop Statistical Analysis Plans and Reports • Summarize, analyze and visualize study data using various statistical methods • Provide statistical consultancy support to sponsors across the full span of clinical development • Oversee third-party statistical and programming deliverables • Maintain current knowledge of relevant research techniques • Support pre-sales discussions to understand client needs • Collaborate with the Product Development team defining key features of KerusCloud • Provide input and support to Marketing of KerusCloud

• Join a company where contributions matter • Be part of a supportive, innovative team • Support pharmaceutical, biotech, and medical device industries • Utilize System Development Life Cycle (SDLC) for programming deliverables • Generate tables, listings, and graphs from clinical trial databases using SAS • Lead study or small programming project teams

• Mastery and trained on 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 trained on SDTM standards including ability to write specifications. • Advanced knowledge of ADaM standards including supporting specification writing. • Proficient with MS Office applications. • Advanced 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.

• Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates • Understanding of how to plan, prepare and conduct GxP audits independently • Ability to support clients with development or refinement of Quality Management Processes or Systems • Project management as it relates to quality and compliance activities • Proficient in authoring and managing audit documents independently • Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently • Assists in other duties relating to overall compliance within Quality and Compliance department, as requested • Must be willing to travel up to 30% of the time for audits within the US; must also be willing to travel internationally as needed