Statistics & Data jobs - 47 jobs

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 ******************* or follow MMS on LinkedIn. 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 * Not required, but experience with orphan drug designations and PSP/PIPs a plus

Job Description 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 ******************* or follow MMS on LinkedIn. Job Overview Our team is growing - join us! We are currently looking to strengthen our Business Development team through the recruitment of a Director, Business Development to support our business development activities. As a member of a global team, you will secure and grow new business for MMS through professional, consultative, and proactive sales activities directed at decision-makers and decision influencers at existing and new customers. This position is primarily remote, but we are searching for someone local to the greater Boston, MA area. Essential Functions Territory management: actively prospect and leverage potential new business opportunities within specified customer accounts. Establish and execute a comprehensive sales plan for each target account within your territory. Ensure appropriate strategy/solution is proposed to the customer. Identify and respond to customer needs to secure potential new business opportunities. Propose an appropriate strategy/solution to the customer and align MMS's key differentiators and service offerings with the customer's needs. Actively lead all aspects of the sales lifecycle for all assigned accounts, from defining potential opportunities to capabilities meetings, proposals, and bid defence meetings. Lifecycle steps include follow-up related to the sale and drive completion of contractual documents. Lead capabilities meetings and bid presentations comprising all aspects of MMS services and solutions. Educate the team participants in customer culture, operational needs/methods and sales techniques needed to close the sale. Cultivate strong, long-term relationships with key decision-makers within accounts and develop in-depth knowledge of the customer organization. Maintain high visibility within the customer organization and monitor satisfaction by communicating regularly with the customer. Maintain visibility in the industry. This may include industry conferences and an active presence on social media (LinkedIn). Adapt successful strategies and tactics to meet market demands and financial targets. Monitor actions and results against plans. Establish and maintain effective, collaborative relationships with internal colleagues, including marketing, proposals/contracts and operational business leads to support specific client requirements and needs. Maintain general knowledge of all MMS services. Record all customer sales-related activities in the CRM system and prepare sales activity reports for management as required. Qualifications 5+ years of related experience, including 3 years of relevant industry experience, preferably in data services (data management and biometrics) or a clinical research environment Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage. Excellent oral and written communication skills Understands the life sciences industry (e.g., CROs, pharma/biotech, medical device), scientific & clinical data/terminology, and the drug development process Ability to work independently and as a team player Ability to establish and maintain effective working relationships with coworkers and clients Experience using a CRM system for the management and tracking of activities and opportunities (MS Dynamics experience a plus) Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel Powered by JazzHR zXcGFrWdre

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 ******************* or follow MMS on LinkedIn. Job 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 and may contribute to improvements. * 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 team work. * Support objectives and improvement efforts within department and organizationally. * Comply with all applicable policies, procedures, and training requirements. * Additional tasks as assigned by manager. Minimum Requirements * 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 program such as SAS procedures. * Excellent organizational and communication skills.

As part of this role, you will be responsible for meeting and exceeding monthly sales targets, identifying and contacting new clients and working together to qualify prospects and develop commercial market leads and work in collaboration with the Business Development Director teams. You will be responsible for active account management, territory research, prospecting, and growing territory in accordance with CTI's corporate objectives. What You'll Do: Achieve and/or exceed weekly and monthly sales metric targets set by CTI Sales Management Develop extensive knowledge about the benefits of CTI's services and expertise Actively prospect and generate new sales and business opportunities within assigned customer territory and in support of the Business Development Director Support identification of cross-selling opportunities into other CTI business units, including RWE, RSA, and lab services Facilitate and attend introductory and capabilities meetings with new prospective clients for CTI Conduct ongoing research for the territory you support using available sales tools such as Salesforce, Zymewire, and other market research tools Qualify and respond to website leads Collaborate with the Business Development Director to support the sales process for new leads from initial introduction through bidding process and contract Gain commitment from Business Development Director to take part and lead introductory or capabilities call with new account(s); complete requests from prospective clients Develop and maintain excellent working relationships with key members of CTI's clinical operational management and internal teams Develop and implement specific disease strategies to drive awareness, lead generation, and opportunity identification Support CTI Conference attendance and support the addition of additional client meeting efforts of the Business Development Sales Director as they attend therapeutically focused conferences globally Continuously monitor and update the status of leads in Salesforce to ensure the pipeline is maintained What You'll Bring: Bachelor's degree in business administration, marketing, or physical/life science Sales experience (including account profiling, relationship development, needs assessment, and account closing) 1 year in pharmaceutical, clinical, or related experience- ideally Why CTI? Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department. Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program. Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market. Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from **************** email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( **************** ) or from our verified LinkedIn page. Please Note We will never communicate with you via Microsoft Teams or text message We will never ask for your bank account information at any point during the recruitment process Equal Opportunity Employer/Veterans/Disabled

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 ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: 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. 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 bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. 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. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 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. Powered by JazzHR 3mKMoVPWsE

Job DescriptionAre 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 ******************* or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: 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 such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data Ability to 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 (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports) 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 Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines Ability to 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 Ability to attend regular team meetings, lead client meeting and CRMs Ability to 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 (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP) Requirements: BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control Knowledge of GLP, ICH guidelines, and applicable regulatory requirements 2+ years of pharmaceutical regulatory nonclinical writing experience Strong writing and analytical skills Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process Powered by JazzHR wgns SFcAsl

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 ******************* or follow MMS on LinkedIn. Job Specific Skills: * 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 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

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 ******************* or follow MMS on LinkedIn. Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time. Job Specific Skills: 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. Job Requirements: Masters required for all Statistics roles. Minimum of 5 years' experience in Statistical Programming or similar field required. Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment. 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.

Job Description 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 ******************* or follow MMS on LinkedIn. Job Overview Our team is growing - join us! We are currently looking to strengthen our Business Development team through the recruitment of a Director, Business Development to support our business development activities. As a member of a global team, you will secure and grow new business for MMS through professional, consultative, and proactive sales activities directed at decision-makers and decision influencers at existing and new customers. This position is primarily remote, but we are searching for someone local to the San Francisco Bay Area Essential Functions Territory management: actively prospect and leverage potential new business opportunities within specified customer accounts. Establish and execute a comprehensive sales plan for each target account within your territory. Ensure appropriate strategy/solution is proposed to the customer. Identify and respond to customer needs to secure potential new business opportunities. Propose an appropriate strategy/solution to the customer and align MMS's key differentiators and service offerings with the customer's needs. Actively lead all aspects of the sales lifecycle for all assigned accounts, from defining potential opportunities to capabilities meetings, proposals, and bid defence meetings. Lifecycle steps include follow-up related to the sale and drive completion of contractual documents. Lead capabilities meetings and bid presentations comprising all aspects of MMS services and solutions. Educate the team participants in customer culture, operational needs/methods and sales techniques needed to close the sale. Cultivate strong, long-term relationships with key decision-makers within accounts and develop in-depth knowledge of the customer organization. Maintain high visibility within the customer organization and monitor satisfaction by communicating regularly with the customer. Maintain visibility in the industry. This may include industry conferences and an active presence on social media (LinkedIn). Adapt successful strategies and tactics to meet market demands and financial targets. Monitor actions and results against plans. Establish and maintain effective, collaborative relationships with internal colleagues, including marketing, proposals/contracts and operational business leads to support specific client requirements and needs. Maintain general knowledge of all MMS services. Record all customer sales-related activities in the CRM system and prepare sales activity reports for management as required. Qualifications 5+ years of related experience, including 3 years of relevant industry experience, preferably in data services (data management and biometrics) or a clinical research environment Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage. Excellent oral and written communication skills Understands the life sciences industry (e.g., CROs, pharma/biotech, medical device), scientific & clinical data/terminology, and the drug development process Ability to work independently and as a team player Ability to establish and maintain effective working relationships with coworkers and clients Experience using a CRM system for the management and tracking of activities and opportunities (MS Dynamics experience a plus) Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel Powered by JazzHR G8aMTR7TOM

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 ******************* or follow MMS on LinkedIn. 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 Not required, but experience with orphan drug designations and PSP/PIPs a plus

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 ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: 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. 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 bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. 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. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 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. Powered by JazzHR Vb1hE8LBAc

Job DescriptionAre 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 ******************* or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: 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 such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data Ability to 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 (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports) 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 Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines Ability to 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 Ability to attend regular team meetings, lead client meeting and CRMs Ability to 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 (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP) Requirements: BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control Knowledge of GLP, ICH guidelines, and applicable regulatory requirements 2+ years of pharmaceutical regulatory nonclinical writing experience Strong writing and analytical skills Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process Powered by JazzHR KWhojlTGLh

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 ******************* or follow MMS on LinkedIn. Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time. Job Specific Skills: 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. Job Requirements: Masters required for all Statistics roles. Minimum of 5 years' experience in Statistical Programming or similar field required. Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment. 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.

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 ******************* or follow MMS on LinkedIn. Job Overview Our team is growing - join us! We are currently looking to strengthen our Business Development team through the recruitment of a Director, Business Development to support our business development activities. As a member of a global team, you will secure and grow new business for MMS through professional, consultative, and proactive sales activities directed at decision-makers and decision influencers at existing and new customers. This position is primarily remote, but we are searching for someone local to the San Francisco Bay Area Essential Functions * Territory management: actively prospect and leverage potential new business opportunities within specified customer accounts. * Establish and execute a comprehensive sales plan for each target account within your territory. Ensure appropriate strategy/solution is proposed to the customer. * Identify and respond to customer needs to secure potential new business opportunities. Propose an appropriate strategy/solution to the customer and align MMS's key differentiators and service offerings with the customer's needs. * Actively lead all aspects of the sales lifecycle for all assigned accounts, from defining potential opportunities to capabilities meetings, proposals, and bid defence meetings. Lifecycle steps include follow-up related to the sale and drive completion of contractual documents. * Lead capabilities meetings and bid presentations comprising all aspects of MMS services and solutions. Educate the team participants in customer culture, operational needs/methods and sales techniques needed to close the sale. * Cultivate strong, long-term relationships with key decision-makers within accounts and develop in-depth knowledge of the customer organization. * Maintain high visibility within the customer organization and monitor satisfaction by communicating regularly with the customer. * Maintain visibility in the industry. This may include industry conferences and an active presence on social media (LinkedIn). * Adapt successful strategies and tactics to meet market demands and financial targets. Monitor actions and results against plans. * Establish and maintain effective, collaborative relationships with internal colleagues, including marketing, proposals/contracts and operational business leads to support specific client requirements and needs. * Maintain general knowledge of all MMS services. * Record all customer sales-related activities in the CRM system and prepare sales activity reports for management as required. Qualifications * 5+ years of related experience, including 3 years of relevant industry experience, preferably in data services (data management and biometrics) or a clinical research environment * Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage. * Excellent oral and written communication skills * Understands the life sciences industry (e.g., CROs, pharma/biotech, medical device), scientific & clinical data/terminology, and the drug development process * Ability to work independently and as a team player * Ability to establish and maintain effective working relationships with coworkers and clients * Experience using a CRM system for the management and tracking of activities and opportunities (MS Dynamics experience a plus) * Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel

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 ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: * 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. * 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 bid defenses. * Proficient in Word, Outlook, PowerPoint, Excel. * 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. Requirements: * Bachelor's Degree required, or relevant work experience. * Minimum of 2 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.

Job DescriptionAre 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 ******************* or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: 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 such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data Ability to 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 (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports) 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 Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines Ability to 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 Ability to attend regular team meetings, lead client meeting and CRMs Ability to 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 (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP) Requirements: BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control Knowledge of GLP, ICH guidelines, and applicable regulatory requirements 2+ years of pharmaceutical regulatory nonclinical writing experience Strong writing and analytical skills Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process Powered by JazzHR JWVqDeM8oN

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 ******************* or follow MMS on LinkedIn. Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time. Job Specific Skills: 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. Job Requirements: Masters required for all Statistics roles. Minimum of 5 years' experience in Statistical Programming or similar field required. Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment. 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. Powered by JazzHR Qg22d4dOw3

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 ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: 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. 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 bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. 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. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 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. Powered by JazzHR WuGhfcHYtF

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 ******************* or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: 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 such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data Ability to 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 (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports) 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 Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines Ability to 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 Ability to attend regular team meetings, lead client meeting and CRMs Ability to 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 (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP) Requirements: BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control Knowledge of GLP, ICH guidelines, and applicable regulatory requirements 2+ years of pharmaceutical regulatory nonclinical writing experience Strong writing and analytical skills Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process