Global Project Manager Salary in Cambridge, MA

DESCRIPTIONAt Audible, we believe stories have the power to transform lives. It’s why we work with some of the world’s leading creators to produce and share audio storytelling with our millions of global listeners. We are dreamers and inventors who come from a wide range of backgrounds and experiences to empower and inspire each other. Imagine your future with us.ABOUT THIS ROLESenior Technical Program Managers (TPMs) are Audible’s relay sprinters, taking projects over the finish line like a champion from concept to launch. As a Senior TPM, you’ll be responsible for the relationship and integration of Audible and Amazon products. This team designs and builds architectures for products that deliver Audible content to users in all sorts of new application domains using back-end services as well as our content on end-user devices and platforms such as iOS, Android, Web, Alexa devices like Echo and more. The team we’re specifically hiring for focuses on tapping the unrealized opportunity landscape within Amazon, where the Audible listening experience still remains unknown to many of our potential customers. Amazon is a vast playground for Audible to experiment and improve upon disruptive customer experiences and add new levels of profitable growth. We need your help to lead and manage projects and processes that will help bring more customers to Audible through our Amazon touch-points. We're a part of Amazon, they are our parent company and it's a great partnership. You'll get to play with all of Amazon's technologies like EC2, SQS and S3 but it doesn't stop there. There's a LOT to learn!ABOUT YOUYou thrive at the heart of the action. At work, change is the only constant – and you wouldn’t have it any other way. Transparency and consistency define your communication skills. You see the bigger picture, letting it guide you, from project risks to retrospectives. “Meticulous” doesn’t do justice to your critical eye. You’re looking for the balance of an energizing start-up culture with the influence of a global e-commerce leader. As a Senior Technical Program Manager, you will…- Play a leading role in running the delivery of large cross functional projects spanning teams and divisions in Audible and outside of Audible (Amazon teams)- Collaborate to define core business objectives in order to deliver the best product, program or project with the most efficient use of company resources- Work with cross functional teams – technology, business and operations to lead multiple projects that have conflicting needs / priorities, from concept to launch- Work with technical astuteness, be detailed oriented and proactive in seeking opens in the projects and drive subsequent closure- Communicate project risks, progress, launches and retrospectives across all stakeholders and teams – consistently and transparently- Strive constantly to improve and establish a new bar in performance (using objective metrics) in project executionABOUT AUDIBLEAudible is the leading producer and provider of audio storytelling. We spark listeners’ imaginations, offering immersive, cinematic experiences full of inspiration and insight to enrich our customers daily lives. Our Hub+Home hybrid workplace model gives employees the flexibility between gathering in a common office space (work from hub) and remote work (work from home). For more information, please visit adbl.co/hybrid.We are open to hiring candidates to work out of one of the following locations:Cambridge, MA, USABASIC QUALIFICATIONS- 7+ years experience in technology project coordination and delivery of distributed multi-tier applications- 4+ years experience managing agile software projects across multiple and geographically distributed teams- Experience in creating or redesigning, rolling out and executing organizational processesPREFERRED QUALIFICATIONS- Scrum / Agile training with 2+ experience in running scrums, sprint grooming & planning, and reviewing agile project metrics- Prior experience in delivering service oriented (SOA) distributed systems- Experience delivering mobile device software and/or retail web applications is highly preferredAmazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.

Senior Manager, Regulatory Project Management - Contract - Cambridge, MAProclinical is seeking a Sr. Manager, Regulatory Project Manager for a leading pharmaceutical company. This is a contract position located in Cambridge, MA.Primary Responsibilities:The role is focused on R&D project management for late-stage global regulatory filings. The successful candidate will be responsible for developing and optimizing detailed regulatory project plans and timelines, maintaining real-time filing timelines, and facilitating critical filing team meetings. This role is crucial in ensuring that timelines and deliverables for NDA/MAA filings are mutually understood and agreed upon.Skills & Requirements:Bachelor's degree in a scientific or medical field preferred with at least 6 years' experience in the biotechnology or pharmaceutical industry.Demonstrated project management skills with the ability to prioritize multiple projects.Experience developing project plans, content plans, and other filing tools.Proficiency in technical systems such as Smartsheet, MS Project, Visio, Excel, Veeva, SharePoint.Excellent organizational and meeting management/facilitation skills.Excellent written and verbal communication skills, including negotiation skills.Ability to work in a fast-paced environment and driven to succeed.Ability to problem solve, identify bottlenecks, and escalate issues appropriately in a timely fashion.Working understanding of regulations and experience in interpretation of Health Authority guidelines.Experience with regulatory filings, original NDA/BLA/MAA, and response to questions is a plus.The Senior Regulatory Project Manager will:Develop and optimize detailed regulatory project plans and timelines in collaboration with various leads.Maintain real-time filing timelines and track deliverables through NDA/MAA submission and registration.Facilitate and co-lead critical filing team and sub-team meetings.Maintain project dashboard for sharing progress and risks with senior management.Identify and highlight project interdependencies.Develop document reviewer matrix and coordinate reviews and roundtables as needed.Plan and facilitate cross-functional workshops focused on execution of submission strategy.Coordinate lessons learned sessions and ensure implementation of feedback for process improvement.Contribute to the development of best practices and standardized process for filing of NDA/MAAs.If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or [email protected] is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.

Responsibilities:Utilizing company's clinical development strategy, while complying with pharmaceutical industry practices and regulatory guidelines, serves as a Sr. Manager of Clinical Science (Clinical Science Lead, Immunology) on the Clinical Research and Development team, responsible for leading or supporting the design, data collection and clinical studies, reporting activities that comprise the development and design of a clinical drug program/portfolio, to determine the drug's efficacy, based on the interpretation of trial results.Serves on the clinical development team, working collaboratively with the Medical Director(s) to develop the clinical development plan for the designated indication. Responsible for the writing of clinical documents, which may include clinical protocols and associated amendments, charters, safety monitoring plans, process documents, scientific manuscripts and abstracts, posters and scientific presentations, briefing documents, IND reports, clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates and the clinical sections of regulatory submissions to support product approvals, etc.Gathers clinical data ensuring that the clinical development process utilized is aligned with strategic objective(s), as well as regulatory reporting requirements (working with biostatistics and data management). Plan for interim data analyses and reviews. Monitors and evaluates emerging clinical data, reviewing, analyzing and interpreting study data, presenting study-related scientific and medical data as a basis for the development and design of the clinical drug program or portfolio.Selects and develops the clinical outcome measure, completing the data review, and undertaking the subsequent clinical trial activities.Select/liaise with extramural consultants (i.e. Data Safety Monitoring Board and Steering Committees).Reviews and interprets data, producing abstracts, presentations and manuscripts.Contribute to development of the clinical protocol by performing medical literature and new technology reviews, seeking input from various R&D functions.Collaborates with the Medical Director(s), clinical operations, and other R&D organizations to conduct clinical review of the study data; reviewing and discussing the clinical study reporting documentation, and as the studies end, securing the data and completing the study reporting.Collaborates with other functions to: develop and implement the overall data quality plan; to review safety narratives and other safety-related guidelines and documentation, while tracking, analyzing, and reporting any potential safety events.May serve as the study point-of-contact regarding questions associated with an assigned study (ies) or program(s) coming from internal functions, such as clinical operations, or externally from a CRO.Remains current on scientific developments, trends and innovative practices that may impact the clinical development organization and the work that the members individually and collectively perform, so as to develop a current understanding and outlook regarding internal and/or external influences, and their implication on Immunology studies.Requirements / Qualifications:This position requires a Bachelor's degree, in the Life Sciences, or the equivalent. An advanced scientific degree (e.g., Master's Degree in Science, a PhD or PharmD) is preferred. Possessing a strong scientific background in the therapeutic area of Immunology. Additional expertise in Gastroenterology, Dermatology, Allergy, and Rheumatology preferred.Possesses a strong scientific background, having five to seven years pharmaceutical industry experience in clinical drug development and the associated regulatory processes. Has extensive knowledge in clinical research, understanding the design and management of clinical trials. Previous experience across Phase I-III drug development projects is required, with a focus on Immunology product development. Academic drug development experience will be considered.Demonstrated understanding of and the experience supporting clinical trial design, having been responsible for developing essential documents (such clinical trial protocols, protocol amendments, case report forms, etc.), along with the driving the execution of the clinical study(s).Project planning skills, focusing on realistic, efficient, and effective plans.Utilizing attention to detail, and strong organizational skills, has established a successful track record managing the clinical strategy and the associated study(s), ensuring the necessary data collection documentation is accomplished for the required analysis and interpretation of clinical trial results.Possesses technical expertise and knowledge of Immunology, specifically the drug compound and the emergence of new technologies and advancements in the care of the patient and treatment of Autoimmune diseases, so as to have the credibility to serve as a liaison with internal/external partners (clinical investigators, key opinion leaders (KOLs), medical directors, etc.).Subject matter expert with a strong analytic background, and compelling written and verbal communication skills, capable of presenting clinical data and complex findings to team members and members of senior management/decision makers, as well as external audiences and/or experts.Recognizing the value of working cross-functionally, demonstrated ability to operate collaboratively to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives, maintaining an awareness of regulatory requirements, as well as commercial objectives.Knowledge of regulatory guidelines and standards (GCP, ICH and regulatory agency (FDA) guidelines).Possesses ability to author scientific documents, including documentation supporting regulatory submissions.High performing and able to work independently, organizing priorities and managing project timelines, while possessing the necessary interpersonal skills and strong analytical skills that enable the successful team collaboration so as to accomplish clinical strategy.Ability to read printed materials and written information on a computer screen is required.Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).As a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.This role requires the incumbent to travel based upon the needs of the business, up to 30% of the time.

Innova Solutions Client is immediately hiring for a Manager/Sr Manager, Data ManagementPosition type: Full Time Perm Location: Preferred location Cambridge, MA / Remote Salary: $175K - $185K depending on experience and level, might go up on the salary for the right candidateAs a Manager/Sr Manager, Data Management you will:RESPONSIBILITIES Manage and supervise a team of Clinical Data Managers (CDMs) Oversee each project assigned to the team QC each deliverable prior to sending to internal or external clients Prepare and present individual performance reviews Provide mentorship to DM staff and suggest/implement solutions for complex issues Assist staff with interactions with sponsors and managing vendors Keep supervisor updated on study progress and staff management through routine meetings Maintain a positive, progressive, and proactive management style and communication Develop and update data management SOPs and training manuals Conduct data management training as well as study specific training for the CDM and study teams Provide input from the data management perspective regarding the design of clinical trial protocols Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures Oversee and participate in the process of data review and query generation procedures Oversee and participate in the coding of medical terms Oversee/define/perform SAE reconciliation processes Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system Ensure proper completion of UAT of EDC system and modules Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation Review queries and trends to ensure data completeness and integrity Review/prepare training materials and user guides for EDC data collection tools, deliver user training Participate in client and team meetings as required advising on best practices as appropriate Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes Implement technical solutions, new tools, and process improvement strategies Lead large and complex projects Identification of project scope changes Present at sales and marketing meetings for prospective clients Provide strategic input to the department and company goals Lead key departmental goals and initiative EDUCATION Minimum BS in a scientific or health related field or equivalent EXPERIENCE Minimum of 10 years of experience in Clinical Data Management Minimum 2 years supervisory experience is required SKILLS Knowledge of GCPs and regulatory agency guidelines Familiarity with medical terminology is required Skilled in the use of data management software application, Medidata RAVE Excellent organizational and time management skills Strong collaboration and leadership skills Excellent oral and written communication skills Strong interpersonal skills Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you!Preeti Sehgal [email protected] RANGE AND BENEFITS: Pay Range*: $175K - $185K depending on experience and level, might go up on the salary for the right candidate *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Job DescriptionManager, Global Regulatory AffairsAbout This Role The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products. You are a member of the Regulatory Project Team for assigned programs and work with direction from regional or global regulatory leads to accomplish a variety of regulatory activities and deliverables including interfacing with the regulatory operations team.What You'll Do Working closely with, and with direction from regional or global regulatory leads, support execution of regulatory strategy, including working closely with the Regulatory team and cross-functional development teams to prepare submission plans (e.g., submission content plan and timeline) for the creation of document packages for regulatory submissions and management of document package preparation, inclusive of new INDs, CTA, NDA/BLAs, MAA, variations.Assist in the preparation for meetings with global health authorities, inclusive of support for briefing book development, and participate in the leadership of these meetings as appropriateEffectively coordinate with the Submission Operations group to ensure on-time preparation and publishing of regulatory submission documentsEnsure regulatory documentation is maintained appropriatelyProvide support for product labeling, Health Authority Information Requests, Annual Reports, Proprietary name submissions, among other regulatory document typesWho You AreYou are a college graduate with a Bachelor of Science degree in a scientific discipline. You are a Regulatory professional with a minimum of 2 years pharmaceutical industry experience in regulatory affairs, with other functional areas taken into consideration.Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.QualificationsRequired Skills BS degree in a scientific disciplineKnowledge and understanding of applicable regulationsExcellent operational skills including planning, organizing and ability to motivate othersAbility to represent the department in project teamsDevelops collaborative relationships to facilitate the accomplishment of work goalsGenerates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunitiesCan build networks to obtain cooperation without relying on authorityAdditional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bd77514-faf2-46eb-b46c-e5ead78a0d62

Innova Solutions is immediately hiring for a Regulatory Affairs Manager III Position: Type: Full Time, Contract Duration: 06 Months (Possibility to extend) Location: 100% Remote or hybrid (Cambridge, MA or RTP) Note: 100% Remote or hybrid (Cambridge, MA or RTP) Job Description: High-Level Description: This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated. Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early stage development programs or working with the Regulatory CMC Lead for late stage development or commercial programs. The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities, as delegated. This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, Regulatory CMC knowledge and interpersonal skills are required. Job Duties: Providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives. Preparation and delivery of CMC Regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (including IND/IMPD/CTAs/MAAs) Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities. Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions Managing CMC aspects of routine and non-routine Health Authority interactions including issue resolution and negotiation of approvals, as delegated. Monitoring changes in the Regulatory CMC environment to support and advise key stakeholders and teams. Providing input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy. Coordinating and completing regulatory assessments of CMC changes in the designated systems Responsible for assuming responsibilities from the Team Lead or Global Regulatory CMC lead, as agreed and delegated and maintaining open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions. Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of Regulatory CMC on cross functional work streams Responsible for leading or assisting in delivery of Regulatory CMC initiatives and the development of Regulatory CMC standards and SOPs, as assigned. Ensure that appropriate records are maintained in the designated system for submission in assigned regions Additional Job Requirements Regulatory skills At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field. Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products (biological, oligonucleotide, and/or chemical entities) Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products Experience of direct communication and negotiation with regulatory agencies on CMC matters Knowledge of GMP requirements and standard systems (e.g. change management systems) Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure Leadership/Management Skills Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones. Ability to influence cross-functional stakeholders to ensure execution of optimal RegCMC strategy Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities. Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively. Demonstrated competency in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical paths. Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures. Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Thank you! Aravind Kumar L K Lead - Recruitment PHONE: (+1) 678-487-8364 EMAIL: [email protected] PAY RANGE AND BENEFITS: Pay Range*: Between $84.00 to $86.00 Per Hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Innova Solutions Client is immediately hiring for a Manager/Sr Manager, Data ManagementPosition type: Full Time PermLocation: Preferred location Cambridge, MA / RemoteSalary: $175K - $185K depending on experience and level, might go up on the salary for the right candidateAs a Manager/Sr Manager, Data Management you will:RESPONSIBILITIESManage and supervise a team of Clinical Data Managers (CDMs) Oversee each project assigned to the teamQC each deliverable prior to sending to internal or external clientsPrepare and present individual performance reviewsProvide mentorship to DM staff and suggest/implement solutions for complex issuesAssist staff with interactions with sponsors and managing vendorsKeep supervisor updated on study progress and staff management through routine meetingsMaintain a positive, progressive, and proactive management style and communicationDevelop and update data management SOPs and training manualsConduct data management training as well as study specific training for the CDM and study teamsProvide input from the data management perspective regarding the design of clinical trial protocolsOversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock ProceduresOversee and participate in the process of data review and query generation proceduresOversee and participate in the coding of medical termsOversee/define/perform SAE reconciliation processesWork with DM leads and DB programmers to design (e)CRFs and edit checks in EDC systemEnsure proper completion of UAT of EDC system and modulesOversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliationReview queries and trends to ensure data completeness and integrityReview/prepare training materials and user guides for EDC data collection tools, deliver user trainingParticipate in client and team meetings as required advising on best practices as appropriateProvide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studiesProvide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changesImplement technical solutions, new tools, and process improvement strategiesLead large and complex projectsIdentification of project scope changesPresent at sales and marketing meetings for prospective clientsProvide strategic input to the department and company goalsLead key departmental goals and initiativeEDUCATIONMinimum BS in a scientific or health related field or equivalentEXPERIENCEMinimum of 10 years of experience in Clinical Data ManagementMinimum 2 years supervisory experience is requiredSKILLSKnowledge of GCPs and regulatory agency guidelinesFamiliarity with medical terminology is requiredSkilled in the use of data management software application, Medidata RAVEExcellent organizational and time management skillsStrong collaboration and leadership skillsExcellent oral and written communication skillsStrong interpersonal skillsQualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.Thank you!Preeti SehgalPAY RANGE AND BENEFITS:Pay Range*: $175K - $185K depending on experience and level, might go up on the salary for the right candidate*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)ClearlyRated® Client Diamond Award Winner (2020)One of the Largest Certified MBE Companies in the NMSDC Network (2022)Advanced Tier Services partner with AWS and Gold with MSWebsite: https://www.innovasolutions.com/Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.Desired Skills and ExperienceEXPERIENCEMinimum of 10 years of experience in Clinical Data ManagementMinimum 2 years supervisory experience is requiredSKILLSKnowledge of GCPs and regulatory agency guidelinesFamiliarity with medical terminology is requiredSkilled in the use of data management software application, Medidata RAVEExcellent organizational and time management skillsStrong collaboration and leadership skillsExcellent oral and written communication skillsStrong interpersonal skillsAmerican Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.

The Role:As a pivotal member of the rare disease team, the Global Marketing & Commercial Lead for Rare Disease will report to the General Manager and drive the execution of a robust commercial strategy for our portfolio, initially focusing on PA and MMA. This strategic role requires collaboration with multidisciplinary teams across R&D, Medical Affairs, Value and Access, and Supply Chain to ensure cohesive efforts within Moderna.This position is accountable for operationalizing asset strategy globally and working at the local market level as well when appropriate. As we build a lean and globally led rare disease business, this role will play an integral role in developing and executing the go-to-market model. This includes representing commercial considerations in strategic decision-making, performing in-depth commercial analyses, developing business cases, and synthesizing insights from various functions. The role also encompasses the management of initiatives that address long-term commercial challenges and engage in scenario planning. Lastly, this role will be instrumental in deploying global marketing efforts and orchestrating the launch and commercialization processes for our rare disease treatments, ensuring readiness and alignment with Moderna's strategic objectives.Here's What You'll Do:Support the development of global commercial strategies for PA & MMA candidates, including future portfolio additions. Balance short-term and long-term priorities and develop actionable plans to achieve established objectives.Lead the creation and execution of launch strategies for PA/MMA candidates, including resource allocation and program planning, and support comprehensive external engagement plans.Collaborate with key stakeholders in R&D, Medical Affairs, Market Access, and Supply Chain to translate and execute the functional business strategy, ensuring alignment with company objectives.Lead the execution of launch and commercialization activities, focusing on global initiatives and priority markets.Provide insights to identify market opportunities and contribute to asset development reviews, evidence generation, and lifecycle planning.Influence future scenario planning and investment decisions by providing a commercial perspective.Support the broader rare disease portfolio strategy development, including TPP refinement.Support the forecasting exercise and financial processes, including leading the development of business cases.Lead the execution and evolution of the integrated launch plan, coordinating with supply chain, regulatory affairs, market access, HEOR, medical affairs, and other functions.Support country launch readiness for PA & MMA candidates, supporting capability building and executing commercial operations within a globally led model.Lead the Rare Disease Integrated Launch Team (RDILT) to ensure preparedness and agility in the go-to-market approach.Champion an innovative mindset in strategizing for rare diseases and developing go-to-market models.Embrace Moderna's mindsets by promoting a culture of creativity and innovation commercialization approaches, including digital strategies, to maximize the potential of medicines.Here's What You'll Need (Minimum Qualifications):Bachelor's degree in Business, Marketing or a related field. Minimum 8 years of progressive marketing experience in the pharma/biotech industry with demonstrated leadership capabilities.Proven experience in strategic planning, launch execution, and commercialization of pharmaceutical products, preferably in rare diseases or specialty care.Here's What You'll Bring to the Table (Preferred Qualifications):Advanced degree (MBA or equivalent) in Business, Marketing, or related field is preferred.Extensive global marketing experience within the pharma/biotech industry, with a strong emphasis on rare disease markets.Demonstrated ability to lead diverse and cross-functional teams both locally and globally, with a track record of successful strategy execution.High learning agility, systems thinking capability, and advanced problem-solving skills to navigate complex market challenges.Exceptional strategic thinking, judgment, and influencing skills, with a history of engaging cross-functional team members and senior leaders to drive commercial success.Demonstrated leadership in setting clear direction, generating commitment, balancing short- and long-term business needs, and constructively resolving issues.Excellent communication skills and a proactive, hands-on approach to achieving results in a dynamic, fast-paced, and growth-oriented environment.Proven experience and knowledge of a broad base of external customers including patients, prescribers, payors, and providers.Evidence of developing compelling global strategies & business cases with proven ability to manage complex and dynamic projects.Excellent project & budget management skills with ability to effectively manage multiple projects & priorities to deliver business objectives.Desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

Company DescriptionAt Biogen, we pioneer in advancing science and strive to drive results whilst effectively managing risk. We are humble and curious and work towards creating a culture of integrity, trust, and treat everyone with openness, care, and dignity. The role of Manager in the Quality Systems & Technology team is aimed to provide quality oversight for computerized systems, technology, and solutions in accordance with GCP and applicable global regulations and Biogen policies and procedures. You will advocate for a risk-based approach to quality management, assess and manage risks as they emerge, and help drive efficiency while also ensuring compliance. You will be expected to build/enhance knowledge of regulatory trends and provide guidance to internal teams relating to the emerging regulations. An understanding of computer system validation and associated regulations combined with competencies in cross collaboration with R&D Quality & Compliance (RDQC), functional leads and IT operations is required.Job DescriptionWhat You'll Do Supporting quality oversight of computer systems and emerging technologies.Participating in process improvements and functional initiatives, as required.Overseeing and approving CAPAs / Effectiveness checks.Understanding of quality by design, risk assessments, quality measures and metrics.Understanding of the principles of data integrity.Supporting and engaging in cross-functional initiatives and ensuring timely execution of defined goals/objectives, including anticipating and identifying project risks, mitigations, and contingencies.Supporting audits and inspections. Supporting closure of regulatory agency commitments and CAPAs specific to systems and technology.QualificationsWho You Are You will have core competencies around project management, quality issue management, process improvement, collaboration and decision making and a thorough understanding of the principles of data integrity, computer system validation and industry regulations. Required Skills Bachelor's Degree required. Master's or Advanced Degree preferred.5-7 years of Clinical Trial/compliance/quality experience working in the biotechnology or pharmaceutical industry.Experience with regulatory inspections.Experience with Quality Management Systems.Must demonstrate extensive knowledge of the principles GCP regulations including data integrity requirements, computer system validation, GAMP 5, medical devices regulations etc.Additional InformationThe base compensation range for this role is $101,600 to $163,700. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9bdd7cb8-9029-424f-bee9-9e8b4e8d9a7e

Program Manager - Business Professional5 Month Initial ContractCambridge, MA - Hybrid - onsite 2-3 days/weekMax PR: $94.21 MUST HAVE'sBachelor's Degree in Science or Business | MS preferred Minimum 3 years of PM experience leading complex pharmaceutical projects in a multi-disciplinary, global environmentPM experience in Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other Drug Development related functionSUMMARYAs part of the GMSO Program Management team, you will report to the Strategy & Operations Lead, GastroenterologyROLELeads the program and project planning efforts of MSTs, in maintaining oversight for the operational plans, execution strategies & critical path for the product.Responsible for coordinating governance approvals for the key project deliverables and holds self and team members accountable to deliver on the agreed upon program objectivesManages project and resource priorities that align with the business objectives.Addresses and resolves project challenges, keeping Unit Head/Lead MPM informed of critical considerations (e.g., resources, performance concerns). Provides clarity and direction in urgent or unexpected situations.Establishes, communicates and executes plans resulting in achievement of project goalsManages the creation of project strategies and supports the MST in presenting these strategies to key stakeholders and decision makers.Adjusts project strategy and priorities in response to changes in strategic direction.Provides direction and obtains buy-in from relevant internal stakeholders and team members to therapeutic, functional, or operational strategy.Identifies ways to accelerate the project execution where possible while maintaining high quality standards.Develops strong logistical skills to manage activities across functions and regionsFacilitate the MST and/or other group meetings and/or other group meetings and ensure agendas are appropriate to enable key discussions and decisions within the team.Manage the planning, operational and reporting logistics of the MST (including but not limited to: meeting schedule management, meeting facilitation, development of meeting materials with contributors, capture and follow up of action items and deliverables, distribution of minutes and maintenance of relevant SharePoint site (or equivalent))Responsible for building quality relationships with key stakeholders, in both TAU and Commercial, that result in valued and trusted partnerships and program support.Proactively identifies potential issues or obstacles and achieves resolution or plans contingencies and follows issues through to resolution, ensuring that MST arrives at a singular conclusion or recommendationsProvides financial oversight for program budget. Includes consolidation, vetting and prioritization of MST spending/ vendors, risks and opportunities, in partnership with the GMUH and in collaboration with GMA functional teams.Leads the project risk management process in the team and generates the cross-functional project risk register for assigned MSTs. Ensure that the risks identified for GMA activities at the MST are reported up through to the Global Program Manager at the GPT for consolidation into the Global Risk Management Plan for the asset.Works closely with the MST cross functional team members to balance operational execution with GMA strategy.Manages project status reporting and dashboards for a given program, including scheduled as well as ad-hoc updates.Generates collaboration, cooperation and communication globally across divisions and functions and between regional representatives in the team ensuring that team goals are achieved.Education & Qualifications Bachelor's Degree science or business-related field (Masters preferred) (PHD acceptable)At least 3 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environmentKnowledge of pharmaceutical industry and Project management experience within Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other drug development related functionKnowledge of the drug development and commercialization process and an understanding of the functions within the pharmaceutical industryProven ability to communicate clearly and present key information objectively and collaborate effectively with managementExperience managing program level budgets across multiple projectsKnowledge of regulatory and compliance guidelines governing medical affairsApplied knowledge of performance measurement (e.g. metrics, dashboards)May travel to the US, EU and other meeting locations internationally. Approximately 5-10% travel may be required (will confirm about travel / may not be required)