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MMS
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  • (Sr) ICF Writer - UK (Remote)  

    - London
    About MMS MMS is an innovative, data-focused CRO that supports the pha... Read More
    About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit  www.mmsholdings.com  or follow MMS on  LinkedIn . Roles & Responsibilities Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias Write and edit clinical development documents, including but not limited to, Informed Consent Forms and Clinical Protocols Complete writing assignments in a timely manner Maintain timelines and workflow of writing assignments Practice good internal and external customer service Highly proficient with styles of writing for various regulatory documents Expert proficiency with client templates & style guides Interact directly and independently with client to coordinate all facets of projects; competent communication skills for projects Contribute substantially to, or manages, production of interpretive guides Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary Mentor medical writers and other members of the project team who are involved in the writing process Requirements At least 3 years of previous experience in the pharmaceutical industry Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline Oncology, General Medicines, Infectious Diseases and Vaccine experience preferred  Substantial informed consent and clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Experienced in understanding complex clinical information Translate complex medical and scientific information into clear, patient-friendly, language   Experienced in collaboration and cross-functional communication Exceptional writing skills are a must Excellent organizational skills and the ability to multi-task are essential prerequisites Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools Experience being a project lead, or managing a project team Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus Not required, but experience with orphan drug designations and PSP/PIPs a plus Should you not have received a response within 14 days of your application, please consider your application unsuccessful. Powered by JazzHR Read Less
  • Business and Finance Analyst - Belfast (CRO Environment, Hybrid)  

    - Belfast
    Are you looking to join a company where your contributions truly matte... Read More
    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. 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 . Financial Reporting and Analysis The Business and Finance Analyst will report to the Senior Director, FP&A and work closely with department leaders to support budgeting, forecasting, revenue modeling, and financial analysis activities. This role will contribute to delivering accurate financial insights, improving reporting processes, and supporting business partners in understanding financial performance. This role will be a Belfast based hybrid position. Main Responsibilities: Support month-end, quarter-end, and year-end financial close processes, including preparation of standard reports, updated forecasts, and management reporting packages. Assist in analyzing monthly, quarterly, and annual P&L variances between actuals, budget, and forecast at the project, department, and company levels. Partner with Accounting to validate financial results and ensure accuracy of reporting. Help identify key trends, risks, and opportunities impacting financial performance and communicate findings to stakeholders. Maintain and update financial models, assumptions, and reporting tools. Business Partnering: Partner with functional teams to support monthly reporting, provide insights on performance vs budget/forecast, and help explain financial results in a clear and actionable way. Support the preparation of materials that “tell the story" behind financial results for business stakeholders. Assist in monitoring departmental spend and identifying opportunities to improve efficiency and margins. Process Improvement and Controls: Support ongoing improvements in financial processes, reporting, and use of systems and tools. Assist in maintaining and enhancing financial controls, policies, and reporting consistency. Contribute to efforts to streamline workflows and improve data quality and reporting accuracy. Other Responsibilities: Respond to inquiries from finance leadership and business partners regarding financial results. Support internal and external audit requests, as needed. Assist with broader Finance initiatives and cross-functional projects. Perform ad hoc analysis and reporting as required. Requirements: Bachelor’s degree in Finance, Accounting, Business, or related field (or equivalent experience).2–4 years of experience in Finance, Accounting, or a related field. Proficiency in Microsoft Office, particularly Excel. Experience with financial systems (e.g., NetSuite) preferred. Strong analytical and problem-solving skills. High attention to detail with the ability to manage multiple priorities and meet deadlines. Strong organizational skills and ability to work in a fast-paced environment. Effective communication skills and ability to collaborate with cross-functional teams. Experience working in a services-based environment with project-based revenue, forecasting, and margin analysis (CRO experience preferred). Basic understanding of clinical trials and drug development processes is a plus. Should you not have received a response within 14 days of your application, please consider your application unsuccessful. Powered by JazzHR Read Less
  • Study Design Statistician - UK (Remote)  

    - London
    Are you looking to join a company where your contributions truly matte... Read More
    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 a 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. 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 . As part of our  Strategic Statistical Services  Arm, this is a full-time role with emphasis on being an internal  and external  SME for clinical trial design, together with  providing consultation to advise  clients on a range of broader statistical issues, and will have an internal job title of  Strategic Statistician. Job Description: Our experienced statisticians and programmers develop intellectual property and assets to support the design and analysis of clinical trials, precision medicine and real-world data analytics. We address the emerging analytics needs of the Industry with our biostatistics services, bespoke algorithms and unique, state of the art, proprietary, cloud-based trial simulation software KerusCloud. Working alongside innovative statisticians you will be responsible for leading the full life-cycle of KerusCloud support and statistical services, from: Assisting customers with their study design with a particular focus on simulation with KerusCloud to ensure they are aligned with the study objectives. Preparation of study protocols and development of Statistical Analysis Plans and Statistical Analysis Reports. Summarize, analyze and visualize study data using a variety of statistical methods, ultimately delivering results to an agreed timeline with optimal quality. Provide statistical consultancy support to sponsors across the full span of clinical development, including oversight of third-party statistical and programming deliverables. Maintain current knowledge of relevant research techniques such as modelling, simulation and experimental design and participate in continuous professional development activity. Support pre-sales discussions to understand and identify client needs, then contribute to technical solutions and resource/ cost estimates. Collaborate with the Product Development team defining key features and statistical aspects of KerusCloud. Provide input and support to Marketing of KerusCloud, including demonstrations to clients, white papers, etc. Requirements: Bachelors degree in mathematics, statistics, physics, pharmacology or with a strong statistical component, Masters or PhD preferred.5-7 years of experience in the application of medical statistics (pharma, CRO, academic). Willingness to engage with clients to understand and research problems and provide creative, business-orientated solutions. Experience in delivering customer projects to high quality standards. Experience in SAS and/ or R statistical software packages. Experience in study design and protocol and report-writing preferred. Experience of modelling and simulation techniques to explore complex study designs preferred. Experience of Bayesian approaches to design and analysis of clinical data preferred. Experience of early-phase drug development processes including innovative/ adaptive study design preferred.  Should you not have received a response within 14 days of your application, please consider your application unsuccessful. Powered by JazzHR Read Less
  • Senior Medical Writer (Remote - UK)  

    - London
    Are you looking to join a company where your contributions truly matte... Read More
    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 a 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.  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 . We are looking for a full-time employee, remotely based within the UK. Responsibilities Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals Complete writing assignments in a timely manner Maintain timelines and workflow of writing assignments Practice good internal and external customer service Highly proficient with styles of writing for various regulatory documents Expert proficiency with client templates & style guides Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects Contribute substantially to, or manages, production of interpretive guides Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary Mentor medical writers and other members of the project team who are involved in the writing process Requirements At least 3 years of previous experience in the pharmaceutical industry Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline Substantial clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus Understanding of clinical data Exceptional writing skills are a must Excellent organizational skills and the ability to multi-task are essential prerequisites Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools Experience being a project lead, or managing a project team Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus Substantial clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Not required, but experience with orphan drug designations and PSP/PIPs a plus Powered by JazzHR Read Less

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany