Jobs at Johns Hopkins Medicine

Location: Remote

Posted Sep 15, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. This position functions as the main point of contact for external clients and potential partners in the advancement of Precision for Medicine goals and business endeavours. Essential functions of the job include but are not limited to:Design and implement relationship development and future sales planning within strategic accounts with focus on supporting current program development and repeat business from current biotech and pharmaceutical companies.Identify leads, qualify targeted Sponsors, conduct introductory and follow up meetings with prospective clients and Regional Vice Presidents of Business Development, secure RFPs and work with the Business Operations/Proposal Team and other staff as applicable to create proposals for new business.Strategically coordinate members of the Executive Team across the business to leverage their respective areas of expertise to successfully bring in new business for the company and finding innovative ways to work across business units to effectively sell PMG services.Represent the company at trade shows and at client-sponsored events.Work closely with Corporate Marketing and with other members of the Executive Team to design and implement a Marketing program to support the sales efforts of the company.Develop and maintain relationships with partner organizations, including data management companies, other CROs and related organizations.Update Salesforce or other metrics tracking software as directed to provide metric driven reporting for company leadership.Provide regular feedback to the Executive Team on the positioning of the company regarding pricing, competitiveness, and market conditions.To maintain close contact with key Sponsor personnel to ensure that client expectations are met or exceeded.The successful candidate will have:Previous experience as a seasoned strategic business development professional within the field of Clinical Research, working for a Clinical Research Organization.A proven track record within the industry in a similar position (Business Development / Account Management / Strategic Development)Bachelors Degree, or equivalent experience ideally in a business, scientific or healthcare discipline l Ability to drive and availability for domestic and international travel including overnight stays Experience with corporate management and sales in the CRO/pharmaceutical industry Possesses a keen understanding of the Oncology and Rare Disease Development market and the role that Precision for Medicine plays in that environment Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment Motivates other members of the company to meet timelines and company goals Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective Demonstrates a high degree of professionalism, as evidenced by ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills in the areas of diplomacy and negotiation Ability to assess and quantify risks to the company, both internal and external Possesses practical knowledge of IT tools and systems in use in the company and on the project teamsPrecision for Medicine is a precision medicine Clinical Research Organization. Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.As our company continues to grow, and expanding into new regions, we are seeking a Director, Strategic Development (Business Development) who will be responsible for continuing this growth in the Asia Pacific Region. This position can be based in Australia, Singapore or South Korea - fully remote with travel.  This is an exciting and pivotal role in our continued growth.  We are looking for an accomplished Business Development Professional with Clinical Research (CRO) industry experience who can make a real impact and reap the rewards!As the Director, Strategic Development you will be responsible for business development and sales activities within the company and assisting in program development for strategic alliances. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments.

employment decisions made without regard reasonable estimate of current range coordinate and lead core rfp

Senior Proposal Manager - Remote

Location: Remote

Posted Sep 13, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$84,200—$121,200 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. Able to identify information gaps and/or discrepancies, unique service requirements and translate information into proposal and budgetCoordinate and lead core RFP development meetings, with attendance from broader company representatives, including sales, operational review and finance teamsDevelop full project budgets using our costing tool template. Competent grasp of Excel based formula applied to assist the team in capturing appropriate details, unique budgetary needs and mapping to complex client grids, as neededPrepare complex proposal text using departmental text templates. Accurately reflect client needs and project team’s strategic message and assumptionsCommunicate, review and negotiate with all partners and third-party vendors during the RFP development processEnsure accuracy and quality control of budget and proposal text edits, working to a high standard of quality outputSupport work order and request for information (RFI) requests, where neededRespond to client questions regarding proposed budget and operational strategy via written and verbal communications. Participate in client meetings as neededAssist in the maintenance of departmental records and internal and intercompany reporting requirementsParticipate in departmental initiativesMay assist in training of lesser experienced team membersMay perform peer reviews providing guidance and comments as necessaryOther duties as neededQualifications:Minimum Required:4-year college degree or equivalent experience ideally in a business, scientific or healthcare discipline5-7 years’ experience of proposal and/or contract development experiencePreferred:Graduate, postgraduate degreePast experience in a CRO environmentCompetencies:Excellent interpersonal, written, and verbal communications skillsExcellent organizational and time management skills with the ability to work independently, prioritizing workload, keeping others informed of progress, timelines and any issues to meet established deadlinesExcellent attention to detail and ability to maintain accuracy under time pressureDemonstrated excellent problem-solving skillsAbility to identify opportunities for improvement and create solutions through continuous and effective communication with managementSound judgment/decision-making skillsHigh proficiency in Excel, Word and other Microsoft applicationsAble to work in a collaborative team environment to support departmental/company goals and valuesMinimal travel may be required for company meetings, clients and vendorsPrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. Provide overall coordination for the entire RFP preparation process, including collaboration with key operational review leads, ensuring accurate incorporation of key strategy and adherence to all key deliverable timelinesProvide extensive review of RFP documents from clients and accurately identify key service requirements and assumptions needed for budget and proposal development. Support Work Order and Request for Information (RFI) deliverables as needed.Essential functions of the job include but are not limited to:Prepare budgets, proposal text and re-bids to support RFP responses for global opportunitiesComplete complex budget and proposal deliverables with promptness, accuracy, and minimal direction from line manager.

Precision for Medicine CRO Senior Statistical Programmers extensive SAS programming experience

Senior Statistical Programmer (SAS - CDISC)

Location: Remote

Posted Sep 08, 2023

Precision for Medicine, a precision medicine CRO, is seeking Senior Statistical Programmers with extensive SAS programming experience in clinical trials. The role involves supporting and leading SAS programming efforts for specific projects, developing and maintaining SAS programs, and providing technical expertise in programming standards. The ideal candidate should have a Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field, and be proficient in SAS macro programming and CDISC standards. Excellent organizational, communication, and problem-solving skills are required. The company values employees' contributions and offers opportunities for growth and mentorship.

without regard to race based on communications in a business scientific

Senior Proposal Manager - Remote

Location: Remote

Posted Sep 13, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Able to identify information gaps and/or discrepancies, unique service requirements and translate information into proposal and budgetCoordinate and lead core RFP development meetings, with attendance from broader company representatives, including sales, operational review and finance teamsDevelop full project budgets using our costing tool template. Competent grasp of Excel based formula applied to assist the team in capturing appropriate details, unique budgetary needs and mapping to complex client grids, as neededPrepare complex proposal text using departmental text templates. Accurately reflect client needs and project team’s strategic message and assumptionsCommunicate, review and negotiate with all partners and third-party vendors during the RFP development processEnsure accuracy and quality control of budget and proposal text edits, working to a high standard of quality outputSupport work order and request for information (RFI) requests, where neededRespond to client questions regarding proposed budget and operational strategy via written and verbal communications. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. Participate in client meetings as neededAssist in the maintenance of departmental records and internal and intercompany reporting requirementsParticipate in departmental initiativesMay assist in training of lesser experienced team membersMay perform peer reviews providing guidance and comments as necessaryOther duties as neededQualifications:Minimum Required:4-year college degree or equivalent experience ideally in a business, scientific or healthcare discipline5-7 years’ experience of proposal and/or contract development experiencePreferred:Graduate, postgraduate degreePast experience in a CRO environmentCompetencies:Excellent interpersonal, written, and verbal communications skillsExcellent organizational and time management skills with the ability to work independently, prioritizing workload, keeping others informed of progress, timelines and any issues to meet established deadlinesExcellent attention to detail and ability to maintain accuracy under time pressureDemonstrated excellent problem-solving skillsAbility to identify opportunities for improvement and create solutions through continuous and effective communication with managementSound judgment/decision-making skillsHigh proficiency in Excel, Word and other Microsoft applicationsAble to work in a collaborative team environment to support departmental/company goals and valuesMinimal travel may be required for company meetings, clients and vendorsAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. Provide overall coordination for the entire RFP preparation process, including collaboration with key operational review leads, ensuring accurate incorporation of key strategy and adherence to all key deliverable timelinesProvide extensive review of RFP documents from clients and accurately identify key service requirements and assumptions needed for budget and proposal development. Support Work Order and Request for Information (RFI) deliverables as needed.Essential functions of the job include but are not limited to:Prepare budgets, proposal text and re-bids to support RFP responses for global opportunitiesComplete complex budget and proposal deliverables with promptness, accuracy, and minimal direction from line manager. Analyzes budgets for company metrics, appropriate pricing and accurate assumptions based on communications across the relative departments, partners and vendors needed for the project. Provide overall accountability for the Request for Proposal (RFP) process and deliverable, working in collaboration with global operational review teams to develop high quality budgets and proposals in response to client Request for Proposals (RFPs) across a range of therapeutic areas.

Associate Director

Location: Remote

Posted Sep 15, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Listens well and seeks input from others.Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.Proven ability to generate new ideas, processes, and strategies to improve the department and ensure the success of sales for the companyKnowledge of the industry, inclusive of competitorsUnquestionable personal integrityComputer skills including Microsoft PowerPoint, Word, Excel, and OutlookAbout Precision for MedicinePrecision medicine is revolutionizing the attack on cancer—and we are passionate about helping our clients harness its power. This position will be responsible for managing and supporting more senior-level team members in the management of the Precision for Medicine Proposals and Business Operations Department.    Essential functions of the job include but are not limited to: Day-to-day management of his/her direct reports or team members; managing assigned workload and ensuring deliverables are developed and delivered according to department best practices.  This may include contracting for newly awarded work, consulting and standalone agreements, and RFIs.Coaching and development of team, including recruitment into new positions as requiredMaintain trackers, reports, and metrics for assigned book of workDevelopment of deliverables such as but not limited to contracts for complex and/or high-profile clients and/or urgent requestsAssists in the creation of departmental processes related to but not limited to: RFI development, Contract developmentAwareness of monthly/quarterly/annual corporate contracting targets.Knowledge of all aspects of the contracting process, including status of legal language, budget updates, financial terms, etc.Proactively checking in with parties involved to understand status and solutioning any roadblocks.Participate in internal team meetings pertaining to contract development, as needed, ensuring that Sponsor needs are being addressed to avoid any delays in progress to executed contract.Work with Business Development and Sponsors to understand the sponsor review and signature process.Support the achievement of company sales goals by optimizing contracting timelines to signatureSupport contract negotiation discussions with clients and facilitate any follow-up actions internallySupport contracting methodologies such as discounts, bonus/penalty, milestones, etc.Support the training and onboarding of all new employeesSupport training of company resources on contracting best practicesProvide excellent customer service to all parties involved in the contracting and RFI processesAdhere to strict code of confidentiality as it relates to study subjects, sponsors, physicians, and policies and procedures of Precision for MedicinePerform other related duties as assigned Qualifications:Bachelors degree, or equivalent experience ideally in a business, scientific or healthcare discipline10 or more years proposal and contract development experience within a CRO or equivalent relevant experience and/or demonstrated competencies.No routine travel is expected for this position; however, periodic local travel to clients and vendors may be required.Previous supervisory experience is preferred.Fluency in EnglishMaster knowledge of industry standards relating to proposal development, and contracts including budgeting, document language processes for creation etc.Demonstrates mastery knowledge of relevant Precision for Medicine’s SOPsExhibits high self-motivation, and is able to work and plan independently as well as in a team environmentConsultative and collaborative approach when dealing with customers and internal team membersHands-on collaborative styleCalm and competent approach to line managementData-driven and focused on results over activityPresent a professional company image and presenceOutstanding organizational and communication skills with ability to effectively communicate and sell his/her ideas at all levels. Are you looking for the next step in your career and to take on a new challenge with a specialist global CRO?Position Summary:The Associate Director, Clinical Work Orders, is a key position within the business development of Precision for Medicine that will play a critical role in coordinating and scaling the department for continued growth and global expansion. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. Due to exciting changes, Precision for Medicine are hiring an Associate Director, Clinical Work Orders to support and develop the team to drive contracting processes in the most efficient manner to support the continued growth of Precision for Medicine!Do you have experience within clinical research in Proposals and Contracts development?

Azure DevOps Engineer

Location: Remote

Posted Sep 12, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$100,000—$140,000 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Are you an Azure DevOps Engineer who wants to work in a high-volume build environment supporting Global Corporate IT Operations?  Do you like orchestrating processes from scripts and automation to full DevOps builds?  Our Cloud Solutions team is hiring an DevOps Engineer to help us build the next phases of our Global IT Infrastructure and grow our expanding team of professionals.THIS IS A FULLY REMOTE OPPORTUNITY, but job seekers must currently reside in United States (ideally in US Eastern time zone).About You:You are an experienced Azure DevOps Engineer who can support, maintain and configure the delivery of builds/deployments across a Global System.You have onboarding new clients/platforms into existing systems and customized configurationsYou have strong Azure skills along with Octopus Deployment tool or Dell Boomi experience.You can work in a dynamic and fast-paced environment with Global team partners.About The Role:The DevOps Engineer will play a key role within the engineering and development teams to implement automation around CI/CD and other core processes to back-end and front-end processing.  Responsible for building out pipelines and increasing quality and efficiency throughout CES processes.  Works across internal development teams to automate key processes and create and maintain pipelines of automation.Implements various development, testing, automation tools, and IT infrastructure including selecting and deploying appropriate CI/CD tools with alignment from CES stakeholdersConfigures and deploys tools and required infrastructure for automation within key development and deployment streamsAdvocates for and builds automated processes wherever possibleDefines and sets development, test, release, update, and support processes for DevOps operationMonitors the processes throughout the CES product lifecycle for adherence to standards and updating or creating new processes to minimize the wastage including incident management and root cause analysisStrives for continuous improvement to achieve an optimal state of integration, development practices, and efficient deployments (CI/CD Pipeline)Coordination and communication within the team and with customers to support adherence to automation and deployment standardsCreates and maintains documentation around automation processes and standardsCreates knowledge base materials dedicated towards operational efficiency while also empowering and enabling the greater CES team to leverage DevOps in multiple technical and non-technical capacitiesRequired Experience:BA in Computer Science or Programming OR Equivalent4+ years previous hands experience in DevOps engineering and or CI/CD pipeline developmentWorking knowledge of various tools, open-source technologies, and cloud servicesWorking knowledge of DevOps practices and removing manual processesExperience supporting multi-tier, consumer-facing web applications at more than just the UI levelExperience with integrating tests and new technologies into in-place CI frameworksKnowledge of various Agile ways of working (Scrum/Kanban) and their benefitsWorking knowledge of Azure DevOps (formerly VSTS) and Git repositoriesWorking knowledge of Octopus Deploy or similar automated deployment and release management toolsFamiliarity of database concepts and data management (RDBMS) and SQLAbility to multi-task and perform effectively under pressureExcellent troubleshootingLI-RemotePrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.

Associate Director, Regulatory Affairs

Location: Remote

Posted Sep 19, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. LI-NC1 LI-RemoteAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. The role will also have direct reports and will support the development of the Regulatory department as well as support and enhance corporate Regulatory functions and facilitate business development and proposals in this area.  Candidates can be based in Spain, UK, Hungary, Poland, Romania, Slovakia or Serbia.Essential functions of the job include but are not limited to: Provide regulatory guidance throughout the clinical development and drug development life cycleLead, oversee and coordinate, review and provide strategic input on applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applicationsDevelop and/or review documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standardsUpon request/ need, represent Global Regulatory Affairs at project team meetings with both external and internal customers and manage/oversee regulatory workflow between departmentsProvide oversight to filing and study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applicationsEnsure budgets and plans meet corporate requirementsProvide ICH/GCP/Regulation guidance, advice and training to internal and external clientsParticipate in developing, implementing, and maintaining the corporate quality initiatives across business units within Clinical Solutions/Precision for Medicine.Mentor, train, and supervise staff at a functional level and supervise contract employees, as applicableGather regulatory intelligence to keep abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval. Interprets emerging guidance and collaborates in impact assessment and implementation.Represent Regulatory function for BD activities including proposal development and review as well as bid defence strategyAssume responsibilities or initiatives in support of the function/company upon request of Regulatory LeadershipMay act as Regulatory Lead for certain assigned projects Job Qualifications: 8+ years or more relevant regulatory affairs experience working for a Clinical Research Organisation, Pharmaceutical or Biotech company.Informed knowledge of all aspects of the drug development process inclusive of regulatory milestonesSpecialized Knowledge of the Clinical Trial Information System (CTIS) under the Clinical Trial Regulation (CTR)Experience of regulatory activities including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, ODDs and PIPs.Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategyKnowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studiedKnowledge and expertise with relevant regulations and guidance supporting pharmaceutical development in the EU and NA regions (mandatory) as well as other global regions (advantage)Able to understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.Ability to guide, train, and supervise personnel; oversees the work of direct reports to ensure on-time, on-target and within-budget resultsAvailability for domestic and international travel including overnight staysPost Graduate Degree, Bachelors degree, or equivalent experience, ideally in a scientific or healthcare disciplineComputer literacy (MS Office/ Office 365)Fluent in EnglishCompetencies: Foster a culture of mutual respect and collaborationAbility to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiencyHigh level of integrity and must inspire exemplary behaviour of high ethics, transparency and demand highest professional standards  Makes decisions based on resource availability and functional objectivesAbility to exercise independent judgement and manage ambiguityAbility to prioritize and delegate tasksAbility to coordinate, manage and supervise multiple projectsResults oriented, accountable, motivated and flexibleExcellent presentation, verbal and written communications skillsProven ability to communicate with senior management, external thought-leaders and operational staffCultivate and maintain excellent professional relationships with clients and colleagues.Precision for Medicine is a precision medicine Clinical Research Organization. The role will lead and support teams for all regulatory submissions and activities in relation to Clinical Trials and drug development.  The position will lead and support teams and efforts around filing activities, Health Authority interaction, attend meetings, and provide regulatory support to other departments, project teams, and committees. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. The Associate Director of Regulatory Affairs will lead teams by providing regulatory strategy and support for all International (inc. North America) regulatory submissions.

Account Director leads client accounts ensures profitability and growth manages team

Account Director - Makara (L&D)

Location: Remote

Posted Sep 09, 2023

The Account Director (AD) is responsible for leading client accounts up to £400K revenue, ensuring profitability and growth. They manage their team, set priorities, and deliver quality work that meets client needs. The AD is involved in pitches for new business, develops annual account planning, and maintains strong client relationships. They ensure financial profitability, manage projects, and identify new business opportunities. The role requires travel, adherence to legal requirements, and commitment to business ethics.

Manager, Strategy & Execution – BioManufacturing Consulting

Location: Boston, MA

Posted Sep 20, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$90,000—$140,000 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. Hold Team Members accountable to a high quality of performance, customer focus, and prioritization of deliverables.  Retain Team Members through developing their strengths, communicating expectations, providing mentorship, coaching, and encouraging and inspiring others.In return for your skills, knowledge, and passion, Project Farma offers a wide range of benefits including: Competitive salary based on experience Aggressive bonus structure  Medical, Dental, and Vision insurance effective your first day of employment  401k Plan with company match Paid Time Off and Company Paid HolidaysCompany Paid Maternity and Parental LeaveContinuing Education Assistance  Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. Foster adaptation and value creation through execution of strategic activities in alignment with market and industry trends.  People Management: Create partnerships, build trust and credibility with Team Members. Clear understanding of the organization’s overall strategy, goals, and vision and an evaluation of external factors such as market and industry trends and competitor analysis and the potential impact on organizational strategy.  Commit to and execute strategic priorities in alignment with changing business needs. Agility: Identify and progress in an ambiguous, complex, innovative, and constantly changing environment. in Life Science, Engineering, Business, or related discipline and/or comparable military experience.Typically, a minimum of 8 years of advanced therapy, life science, pharmaceutical, or biotech experience.Typically, 6 years of managing high-performing teams.Typically, 4 years business development, lead generation, or sales experience.Experience translating client visions to set the direction, frame the project, provide clarity to direct reports and client, and deliver results.Other Required:Full COVID-19 vaccination is required prior to the Team Member’s start date with exceptions for medical and religious accommodations when reasonable.Travel as needed to fulfill Business Development and Team Member initiatives.Key Competencies:Change Management: Anticipate the impact of change, identify, and communicate the need for change and successfully implement, promote, and execute the acceptance of change across the organization in alignment with strategic goals and initiatives.Strategic Prioritization and Decision Making: Consider multiple options, weigh the potential outcomes and risks associated, and choose the most appropriate solution. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.

Senior Proposal Manager - Remote

Location: Remote

Posted Sep 13, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$84,200—$121,200 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. Able to identify information gaps and/or discrepancies, unique service requirements and translate information into proposal and budgetCoordinate and lead core RFP development meetings, with attendance from broader company representatives, including sales, operational review and finance teamsDevelop full project budgets using our costing tool template. Competent grasp of Excel based formula applied to assist the team in capturing appropriate details, unique budgetary needs and mapping to complex client grids, as neededPrepare complex proposal text using departmental text templates. Accurately reflect client needs and project team’s strategic message and assumptionsCommunicate, review and negotiate with all partners and third-party vendors during the RFP development processEnsure accuracy and quality control of budget and proposal text edits, working to a high standard of quality outputSupport work order and request for information (RFI) requests, where neededRespond to client questions regarding proposed budget and operational strategy via written and verbal communications. Participate in client meetings as neededAssist in the maintenance of departmental records and internal and intercompany reporting requirementsParticipate in departmental initiativesMay assist in training of lesser experienced team membersMay perform peer reviews providing guidance and comments as necessaryOther duties as neededQualifications:Minimum Required:4-year college degree or equivalent experience ideally in a business, scientific or healthcare discipline5-7 years’ experience of proposal and/or contract development experiencePreferred:Graduate, postgraduate degreePast experience in a CRO environmentCompetencies:Excellent interpersonal, written, and verbal communications skillsExcellent organizational and time management skills with the ability to work independently, prioritizing workload, keeping others informed of progress, timelines and any issues to meet established deadlinesExcellent attention to detail and ability to maintain accuracy under time pressureDemonstrated excellent problem-solving skillsAbility to identify opportunities for improvement and create solutions through continuous and effective communication with managementSound judgment/decision-making skillsHigh proficiency in Excel, Word and other Microsoft applicationsAble to work in a collaborative team environment to support departmental/company goals and valuesMinimal travel may be required for company meetings, clients and vendorsPrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. Provide overall coordination for the entire RFP preparation process, including collaboration with key operational review leads, ensuring accurate incorporation of key strategy and adherence to all key deliverable timelinesProvide extensive review of RFP documents from clients and accurately identify key service requirements and assumptions needed for budget and proposal development. Support Work Order and Request for Information (RFI) deliverables as needed.Essential functions of the job include but are not limited to:Prepare budgets, proposal text and re-bids to support RFP responses for global opportunitiesComplete complex budget and proposal deliverables with promptness, accuracy, and minimal direction from line manager.

training programs online selfstudy instructional material handouts evaluation training aids visual aids

Director, Learning and Development

Location: Remote

Posted Sep 13, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. indication training, GCP training, etc. Determines most effective delivery model(s) for training programs (online, self-study, classroom, etc. )Prepares and distributes training aids such as instructional material, handouts, evaluation forms, and visual aids. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$140,000—$190,000 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. )Ensures that all training materials and programs are compliant with laws and regulations governing the industryKeeps up with and applies the latest teaching techniques to a program delivery training environmentWorks to keep training programs vibrant and entertaining in order to engage employees and traineesCollaborates with Quality Assurance to identify potential training topics based on noted deficiencies in audits or adherence to Standard Operating Procedures (SOPs), project plans and/or job descriptionsAssists with the development/review of relevant SOPsIdentifies, evaluates, selects, and manages third party vendors/consultants in the development and delivery of learning content.Coordinates and delivers educational programsManages resources to ensure financial objectives are met within departmentPerforms other tasks and assignments as needed and specified by management.Qualifications:Minimum Required:Bachelor’s degree, or equivalent experience ideally in a scientific or healthcare discipline10 years in a relevant life sciences role or equivalent experience or demonstrated competencies in the key requirements of the roleAt least 7 years as in operational project management or Learning & development, either in a Clinical Research Organization, Specialty laboratory or sponsor environment or equivalent experienceOther Required:Demonstrated experience designing, implementing, and monitoring the strategies, programs, tools and processes that support organizational performance and contribute to employee engagementAbility to deliver classroom instructionAbility to influence without direct authorityExcellent planning, organizational, time management skills including the ability to support and prioritize multiple projectsAnalytical thinker with excellent problem-solving skills, the ability to adapt to changing priorities and deadlinesAbility to work independently, collaboratively, as required in a fast-paced, matrixed, team environment consisting of internal and external team membersProficiency with Microsoft OfficeExcellent verbal and written communication and skillsDemonstrated ability to collaborate with internal key stakeholders and senior functional and organizational leadershipCore understanding of medical terminology and clinical trial activities in relation to execution of a clinical developmentExpert knowledge of ICH/GCP guidelines and regulations as relates to clinical trials and trial managementAbility to travel domestically and internationally (includes overnight travel)Preferred:Advanced degreePeople management experienceGlobal Training development and deliveryCompetencies: Able to communicate in an effective, global/multicultural manner, where English may be a secondary languageHighly motivated and inquisitive; concise, articulate, and creativeAbility to distill complex concepts into simple, understandable communicationsExtremely collaborative, a team player, an outstanding communications consultantAble to manage through “influence” versus a direct reporting lineExcellent attention to detail and ability to see and work towards a big pictureComfortable with a fast-paced, always-on, quickly changing environment and deadline drivenAbility to transition seamlessly among projects of varying scale, audience, format, and distribution channelsUnderstands clinical trials methodology across all Functional Service lines Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skillsDemonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidanceFluent in EnglishPrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. Creates implementation timelines and adapts deployment of personnel as needed to support operational objectives. Director, Learning & Development, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate within assigned region/area of responsibility.Essential functions of the job include but are not limited to: Manages and provides leadership to L&D team members with assigned region/area of responsibility.Collaborates closely with key internal stakeholders to identify, prioritize, and define organizational needs and to develop, implement and evaluate training curricula.Develops programs and initiatives that align with, and support, organizational vision, priorities, and goals.Conducts consultations, facilitates discussions, and leads the analysis and identification of internal customers’ learning needs. Develops customized strategies and plans to address these needs effectively and efficiently.Leads the development and implementation of learning deliverables designed to meet global needs.Defines the methods and metrics to track, monitor and measure progress against organizational development and learning-relatedContinuously evaluates systems, processes and procedures for potential improvements and implements these improvements asDevelops training and policies by assessing, trends, and variances; aligning monetary resources; developing action plans; measuring and analyzing results; initiating corrective actions; minimizing the impact of variances.Oversee and participate in the development of training materialsIdentifies training and development opportunities and works with appropriate subject matter experts (internal and external) to develop training and development programs (i.e.

Start up Lead

Location: Remote

Posted Sep 15, 2023

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.Essential functions of the job include but are not limited to: • Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.• Responsible to co-ordinate translations for documents required for submissions.• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.• If needed, directly support country or site level activities start up activities.• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.• Interact with clients in proposal activities, including slide development and client presentation as required.• Performs other duties as assigned by management.Qualifications:Minimum Required:• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.• 5 years or more in start up, with SU Lead or PM experience managing multiple countries in either a CRO or pharmaceutical/biotech industryOther Required:• Demonstrated leadership experience in driving cross-functional activities• Excellent communication and organizational skills are essential. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.• Fluency in English and for non-English speaking countries the local language of country where position based.• Experience using milestone tracking tools/systemsPreferred:• Advanced degree in life sciences or related fieldCompetencies:• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.• Excellent organizational skills.• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.• Must demonstrate excellent computer skills.• Excellent time management and prioritization skills to ensure deadlines are met.• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.• Occasional travel may be required.LI-NC1 LI-RemoteAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected]. Precision for Medicine (CRO) are hiring an experienced Start up Lead who have a passion for site start up to join our team, candidates can be based in the following countries:  Spain, Hungary, Slovakia, Serbia, Romania or Poland.  Position Summary:The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such asCore/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages.