Life Insurance Jobs in Cambridge
3,332 open positions · Updated daily
Looking for Life Insurance jobs in Cambridge? Browse our curated listings with transparent salary information to find the perfect Life Insurance position in the Cambridge area.
Senior Program Director - Bio Innovation Hub
Company: Novo Nordisk
Location: Cambridge
Posted Sep 25, 2023
Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. Together, we're life changing. Novo Nordisk is an equal opportunity employer. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. Qualifications MS or MD, Degree within natural sciences is required, PhD and/or MBA strongly preferred 15+ years' relevant professional experience (if applicable, PhD time included): Project management experience leading cross-functional projects (prefer 5+ years in global projects); experience managing larger programs (not individual projects) is preferred Previous experience managing strategic alliances with demonstrated value creation is preferred Ability to run programs and projects independently and in close cooperation with colleagues across Novo Nordisk to ensure a holistic strategic solution to often multifaceted business problems As decisions involve coordination with other internal stakeholders in the HQ organization, affiliates, and external stakeholders, the ability to successfully navigate internal dynamics is required and experience working in a matrix organization preferred Demonstrated ability to present to, influence and build rapport with senior management Understanding the interface btw Legal, business development and alliance management Strong scientific and business understanding across R&D, and ideally experience from translational medicine / pre-clinical drug development Strong intercultural understanding and global collaboration capabilities both internally and externally High capacity for idea generation, hypothesis testing and problem solving, the ability to consolidate large amounts of complex information in a dynamic environment and to think outside the box to arrive at creative solutions Excellent collaboration, influential leadership skills and an ability to learn the Novo Nordisk business and organization, as well as the general pharma/biotech industry, is preferred Ability to motivate and influence others to advance goals, and the ability to effectively manage multiple projects or roles in a rapidly evolving environment Demonstrated ability to make strategic recommendations and manage risk with timely go/no-go decisions at all stages of the project/program delivery process Knowledge about different cultures, practices and procedures often required Demonstrates excellent verbal and written communication skills Proficient in Microsoft Office suite of products (Outlook, Excel, Word, PowerPoint) We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Ensure identification of best practices internally and externally and facilitate continuous improvement and innovation with the overall program, overall serving as a committed role model externally as well as internally Draw on and delegate into Line of Business and across Novo Nordisk SVP areas through multiple levels of employees and scientific experts to drive outcome, based on a clear sense of direction High independence and initiative should always be demonstrated when planning for, improving and performing tasks assigned by management In general, decisions are complex and involve coordination with other internal stakeholders in the HQ organization, affiliates, and external stakeholders for this position Assignments are characterized by high variability, complexity, and often by lack of precedence Actively connect and feed knowledge into the Global Novo Nordisk R&D organization, with a specific focus on diverse innovation approaches and lean project plan executions (early program and project de-risking), new ways of working, as well as asset transitioning Expected to actively challenge the ordinary processes and priorities upwards in the organizational hierarchy up to Executive Vice President level As the anchor of Quality, Improvement, and Knowledge sharing, this role requires the ability to identify better practices and create improvements in processes and approaches, as well as proactive action on quality and compliance-related matter Responsible for documentation and strategies required for regulatory submissions Ensure working in compliance with QMS, EHS and OHS standards Physical Requirements 0-10% overnight travel required. budget responsibility (15-70m USD) with the Bio Innovation Hub's strategic partners and collaborations, and manage and nurture existing business partnerships to maximize the value to Novo Nordisk Proactively engage with the core R&D organization to solve scientific challenges identified during product concept development and utilize the DK based Navigators to transfer assets, scientific challenges, and knowledge to the core research and early development organization Drive translational R&D plans for novel product concepts, actively engage with cross-functional Novo Nordisk R&D teams to execute on co-created R&D plans and ensure that decisions are guided by scientific and translational priorities, even when complex analysis of situations and data is required. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. The role will be the interface between the Bio Innovation Hub and the greater NN organization, including engaging with colleagues in Global Drug Discovery and Research Technologies, as well as the wider R&D organization across EVP/SVP areas. The holder of this role is responsible for managing a portfolio of projects that each require cross-functional teams operating across 2-3 companies, including biotech companies, venture capital firms, and academic institutions typically interacting at C-level in Joint Steering Committees.
Senior Director, Immunology
Company: Montai Health
Location: Cambridge
Posted Sep 21, 2023
In 2021, Flagship Pioneering was ranked 12th globally on Fortune’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies.Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. Creative drug developer can contribute to scientific direction of MontaiRecognized expertise in discipline externally with good publication record, partnerships and collaborations with the external scientific communityFlagship Pioneering has conceived of and created companies such as Moderna Therapeutics (NASDAQ: MRNA), Editas Medicine (NASDAQ: EDIT), Omega Therapeutics (NASDAQ: OMGA), Seres Therapeutics (NASDAQ: MCRB), and Indigo Agriculture. Since its launch in 2000, Flagship has applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. This individual should possess the ability to organize and prioritize workstreams as well as to lead, mentor and inspire the team. Key Responsibilities:Work with a world class multidisciplinary team of drug discovery scientists to advance multiple small molecule programs as new clinical candidates for the treatment of inflammatory and autoimmune diseasesDevelops, leads, and provides scientific leadership to cross-functional project teams through the creation and execution of high- quality integrated discovery and preclinical research plansFor each program, define key experiments critical for target validation, and in vitroand in vivo pharmacology and efficacy in order to establish a strong case development candidate and advance towards development and IND-enabling studiesCoaching and mentoring of scientists in the team to work on defining a critical path for each project and efficient delivery of data to enable go/no-go decisionsResponsible for facilitating strong collaborations internally and externally (CRO, academics, patient organizations) to identify and facilitate biological assays, technologies, and novel and innovative collaboration to enable discovery efforts and program progressionInterface with senior management across therapeutic area research, research operations, automation, machine learning and drug discovery to ensure model, assay and screening development meets the needs of our discovery pipeline projectsPreparing, presenting and reviewing scientific presentations for internal/external useWork effectively with the leadership team to ensure timely and seamless transition to clinical development for each programContribute effectively to patent, study report, filings and scientific publication writingQualifications:PhD. in immunology preferred or PhD in biology, pharmacology or a related scientific discipline would be acceptable with prior experience in inflammatory and immunological diseases10+ year’s industry experience in progressive drug discovery-related activities, experience in small start-up is preferredRequired Experience:Design and execution of experimental strategies including defining the relevant assays and disease models to validate targets and explore pathway involvement in various inflammatory and autoimmune diseases.Ability to prioritize responsibilities to meet project deadlinesExperience working in project teams within the biotech/pharmaceutical industry.Experience leading and/or working on successful early discovery and preclinical research, IND-enabling activitiesPrior experience in leading and advancing programs from early discovery to clinical developmentExcellent organizational and prioritization skills, ability of adaptively managing priorities amidst fluctuating circumstancesStrong team player who is solution oriented.Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.Strong record of leading teams and demonstrated ability to influence at the Leadership Team levelDemonstrated ability to develop, and retain talentCritical thinking with the ability to analyze possibilities and solutions and make pragmatic trade-offsAbility to drive to data-based decisions involving internal and external stakeholders so as to deliver on organizational goalsAbility to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicityExcellent written and oral communication skills, including setting clear meeting agendas, clear documentation and communication of scientific results and conclusions for internal and external presentations (scientific meetings, Board and investor decks)Excitement about the vision and mission of MontaiProven track record of scientific innovation and success in delivering development/clinical candidates. The ideal candidate should have a high degree of problem-solving capabilities as well as excellent communication skills. The company leverages a multidisciplinary approach that integrates tools ranging from machine learning and big data to multi-omics and high-throughput screening.At Montai, we nurture a bold, spirited and leading-edge culture dedicated to strengthening human health:We are one team with omnidirectional trust, empowered and accountableWe are strong as individuals but stronger as a team and we are committed to excellenceWe have a sense of urgency and persistence and we are crazily confident that we can make a differenceWe need to be comfortable with the uncomfortable and be rigorous and we recognize that failure is dataWe care for diversity in people, thought, personality, opinions, background and distinctivenessWe have a sense of humor to help us manage through our strategic noiseReporting to the CSO, the Senior Director of Immunology research will enjoy working in a collaborative, innovative and fast-paced biopharmaceutical environment. What if… you could join an organization that creates, resources, and builds life sciences companies that invent breakthrough technologies in order to transform health care and sustainability?Montai Health is a privately held, early-stage biotechnology company developing a platform for understanding and leveraging complex molecular interactions within organisms to solve global challenges in human health and sustainability.
Executive Assistant, Legal & Compliance
Company: Amylyx
Location: Cambridge
Posted Oct 06, 2023
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Support the Chief Legal Officer & General Counsel in preparing agendas, collecting and reviewing presentation materials, reserving conference rooms and coordinating video conferences (MS Teams, Zoom, etc. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. including opening and closing POs, processing invoices, onboarding new vendors, managing vendor offboarding process.Partner with other Executive Assistants to organize corporate events and meetings and Extended Leadership Team meetings. Work with Legal/Compliance functional leaders to build annual budget, ensuring new line items are assigned to appropriate budget code; track and review quarterly forecast.Support the Legal/Compliance team with the management of POs, invoices, etc. ).Make recommendations for new ways of managing workflows and process improvements as needed.Develop collaborative relationships with the Executive Assistant to the Co-CEOs, the Executive Assistant to the CFO, the Executive Assistant to the CCO, and the Executive Assistant to the CHRO providing back-up support as needed.Coordinate domestic and international travel as well as process travel & expense reports for reimbursement.REQUIREMENTS8+ years of experience supporting C-Level executives.Bachelor’s Degree and Legal experience a plus but not required.Excellent organizational and prioritization abilities with meticulous attention to detail.Strong interpersonal and communication skills with the ability to build and nurture relationships with stakeholders, including employees at all levels, executives, and board members.Incredibly proactive; able to anticipate needs and prioritize day to day work and projects based on the demands of the business.Anticipate and resolve issues.Proven time management skills with the ability to handle multiple tasks, execute effectively against multiple projects and deadlines, and remain cool under pressure.Demonstrated ability to operate independently, use sound judgement and professionalism.Applies confidentiality and accuracy to work and interactions with employees and external partners.Demonstrated proactive approaches to problem-solving,Resourceful team-player, with the ability to also be extremely effective independently.Highly proficient in Microsoft Office Suite and an ability to learn additional project management and collaboration tools.Contracts Management Systems experience preferred.Able to work cross-functionally in a matrix environment.Years of experience and educationTo stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. Provide support in the preparation of executive and Board of Directors materials, helping to iterate presentations, reviewing documents for content flow and accuracy.Support the Chief Legal Officer & General Counsel in preparations for monthly Board meetings, ensuring meeting materials are received on time, providing presenters with guidance on effective presentations, coordinating with the Executive Assistant to Co-CEO’s to understand potential conflicts.Support other members of the Legal & Compliance department for various administrative needs across the function, including but not limited to supporting the Global Compliance Officer in implementation of the compliance program, Intellectual Property docket management, tracking state licensures, issuing and tracking litigation holds, and supporting implementation and upkeep of a contract management system.Manage Legal & Compliance budget, tracking budgeted and unbudgeted spend against Purchase Orders (PO) and invoices, and providing awareness on actual to budget. Must be a team player, responsive and able to function independently, manage highly confidential and sensitive information and matters with the utmost discretion.The person in this role will have exceptional written and verbal communication skills, with the ability to create and edit communications, meeting notes when required, meeting preparation materials, and presentations, ensuring accuracy, attention to detail, and follow through. This position offers a unique opportunity to be part of a highly respected Legal & Compliance team and support a key leader in the organization.RESPONSIBILITIESWork closely and effectively with the Chief Legal Officer & General Counsel, providing support in organizing meetings and calendar management, prioritizing appropriately.Draft and/or edit materials including documents, PowerPoint presentations, and reports. In this visible role, the Executive Assistant, Legal & Compliance is responsible for proactively listening, anticipating and meeting priorities in a fast-paced environment.
Archive-Submittals Coordinator
Company: SMMA
Location: Cambridge
Posted Sep 22, 2023
We are guided by a shared pursuit of design excellence, sustainability, and social responsibility. Company Perks Employee-owned firm with Employee Stock Ownership Program Hybrid work-from-home policy Competitive benefits including paid time-off, company-funded MA Paid Family and Medical Leave, company-paid dental plan, company-paid life insurance, and 401(K) matching Employee Assistance Program (includes confidential emotional support, legal guidance, and financial resources) Mentor/protégé program Educational reimbursement Licensure and membership reimbursement “Lunch and Learns” with internal and external speakers Today, we remain dedicated to this flexible, integrated approach. Our work straddles seven markets—K-12, Higher Education, Corporate, Commercial, Life Science, Federal Government, and Advanced Technology—with the opportunity to work across a wide range of projects and specialisms. Cambridge-based since our incorporation in 1955, we offer an integrated, multidisciplinary environment driven by collaboration between architects, interior designers, engineers, technologists, researchers, and industry experts. We offer a fast-paced, team-oriented environment that promotes intellectual and creative growth. SMMA was founded by MIT and Rensselaer alumni who believed that the balance of architecture, engineering, interiors, and site design afforded clients the agility of a single source of creative and technical expertise. Key Archive Responsibilities Assist with digital asset management, records management, and project close-out activities Organize and inventory drawings and project documentation Preserve and rehouse archival material in various formats Assist with the preparation of archival materials for transfer to off-site storage and clients Key Submittals Responsibilities Process and track shop drawings and samples with respective trades (Ex: architectural, structural, MEP, specialist consultants) Coordinate with respective trades, contractors, and consultants during construction phase Prepare shop drawing status reports Respond to technical and coordination issues related to tracking of shop drawings Set up QC reviews and coordinate with project managers, consultants, and clients Secondary Responsibilities As needed additional support for administrative team members to cover vacations and absences. Print Room services: Printing, coordinate delivery services, travel arrangements, and mail distribution Administrative services: catering requests, meeting arrangements, and occasional reception coverage Key Competencies Proficient with Bluebeam, Acrobat, and MS Office including Word, Excel, Teams, and Outlook Ability to work in a team environment and on an individual basis Ability to communicate both verbally and in writing Good interpersonal skills and attention to detail Ability to work well under pressure Well-organized and flexible, with the ability to prioritize tasks in a fast-paced environment Strong organizational, interpersonal, and communication skills Minimum Qualifications Current college student actively pursuing a degree in Architecture, Engineering, or Interior Design Technical knowledge of the AE industry or experience as a librarian Two years of general office experience Ability to lift and carry boxes weighing up to 40 pounds and move furniture Ability to stand, stoop, bend, and work in tight spaces About the Firm SMMA is one of New England’s most unique design firms due to our composition, reputation, and focus. We focus on building lasting relationships with strategic partners in both the public and private markets. As an employee-owned firm, we believe that good ideas are welcome from anywhere. The primary responsibility of the Archive/Submittals Coordinator will be to maintain control over project archives and shop drawings through a computerized database and to ensure proper filing, storage, and retrieval of documents. The secondary responsibility will be to provide print room and administrative support. SMMA is seeking an Archive/Submittals Coordinator to handle project document archiving maintaining control over a computerized database of historic project information, and to manage project submissions and approve shop drawings and samples from consultants.
Head of People Operations
Company: Relay Therapeutics
Location: Cambridge
Posted Sep 21, 2023
We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us! This is a great opportunity for someone who wants to make an impact and cares deeply about getting medicines to patients in need. Your RoleSet and oversee the direction of the People Operations function in support of the strategic objectives of Relay Tx and the People team Provide strategic input and operational leadership in the design, implementation, administration, and communication of compensation, benefit, and equity plans, systems, programs, and policies Mentor and manage the People Operations team Build and foster partnerships with key stakeholders including Finance, Legal, Operations, IT, as well as external vendors and partners Ensure that we have the key systems and processes in place to provide a seamless employee experience from onboarding to offboarding Enable the People team to collect, analyze and provide timely, value added and impactful data to support business activities and decisionsSupport our compensation strategy and oversee our compensation administration in partnership with our Finance team Lead our benefits strategy and execution, including benefits design, ESPP and 401k administration, and broker management In partnership with Legal and Finance, ensure compliance with state and federal laws and regulations, inclusive of filings, reports, and audits Your BackgroundYou have experience working within the guidelines of a publicly traded company You know what a successful People Operations function looks like in a dynamic, scaling organization You have a track record of developing strong partnerships with key stakeholders and other leaders You have a reputation for being an effective leader who can energize and motivate your teams and develop your employees You have a meticulous attention to detail You are service oriented and have an employee-first mentality – you know what it means to be white glove You are a clear, candid, and concise communicator – whether in person, by phone/ email, or in front of an audience presenting Biotech experience a plus LI-AM1About Relay TherapeuticsRelay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. This “hands-on” leader will partner closely with leaders in Finance, Legal, IT, and Operations to oversee companywide programs and initiatives related to People Operations. We are seeking an experienced and versatile People Operations leader who will lead our dynamic People Operations function. This position provides leadership and strategic direction to the People Operations function. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. The OpportunityRelay Tx is advancing a&8239;broad&8239;pipeline of promising&8239;precision medicines developed via our Dynamo platform and changing the way drugs are discovered along the way. Through unparalleled insights into protein motion, we are able to develop highly selective drugs against important disease drivers.
Director - Alliance Management
Company: Novo Nordisk
Location: Cambridge
Posted Sep 26, 2023
Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. Together, we're life changing. Novo Nordisk is an equal opportunity employer. The job requires global collaborations with R&D teams based in Denmark, China, and Boston, Seattle, and Indianapolis within the US. The Director will report to the Corporate VP of Early Innovation, Outreach & Alliances, and be tethered administratively to the VP, Site Head of Novo Nordisk Research Center Seattle, Inc. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. Qualifications Ph.D. or MD with 8+ years or a Master's with 10+ years within medicine, science, pharmacy or similar required. The Director shows solid communication skills, contextual understanding, shows ability to influence a project team, and shows solid contractual understanding. Essential Functions Ensure optimal negotiation of contracts relevant for Novo Nordisk alliances Support portfolio of alliances towards agreed milestones and outcomes Develop, suggest, and champion new alliances in alignment with the R&D strategy In collaboration with relevant dept. The Director provides solid oversight, enables, and monitors a significant range of alliance management activities, is involved in the deal negotiation, stirs governance set-ups of certain complexity, and has a diverse portfolio of alliances.
Digital Public Relations Associate
Company: Insurify
Location: Cambridge
Posted Oct 11, 2023
We’re changing the way millions of people compare and buy insurance with artificial intelligence, technology, and superior product design.Our team is highly analytical, fast-moving, and focused on one thing: getting more people to compare insurance quotes using Insurify.Join us if you like: $1.3 Trillion market opportunityMIT alumni foundersFemale-led startup$130M total fundingStrong leadership team from Kayak, Amazon, Wayfair, Facebook, Microsoft, Allstate, GEICO, Liberty Mutual, ZillowHow you will make an impact:Support audience growth goals through earning references, citations and backlinks to Insurify in key digital media outletsCurate media and contact lists for our key target audience cohorts, including key media outlets such as major publications, national and regional news media, affiliates & direct partnersBuild and nurture relationships with journalists and editors at these key media outlets, understanding their interests and how our data, content, studies and reports can resonate with them and their audiencesRegularly review successes and opportunities for improvements to build an experimentation program designed to test, learn, and optimize all input processes that drive towards our outreach and audience growth goals Work to keep on top of key media trends and breaking newsPlay a key role in creating a proactive content strategy that drives media attention and builds authorityAnalyze competitor content and successes to identify opportunities for improvement Contribute to the digital PR strategy for topics including auto and homeownership in relation to insurance Work up to owning outreach campaigns from ideation of data content to pitchingWho you are:A self-starter who is comfortable using data in storytelling You have 1-3 years of writing, data analysis or digital PR experience You already understand or are interested in how links make an impact on SEOYou are excited about brainstorming and shipping new data-driven content ideasYou are always looking for incremental ways to improve whatever you are working onYou love writing and have strong communication skills You are an analytical person who dives deep to understand the “why” behind questionsYou are a detailed-oriented person who takes time to understand what will engage your audience Benefits:Competitive compensationGenerous stock optionsHealth, Dental Coverages401K plan with matchUnlimited PTOGenerous company holiday calendarLearning & Development StipendsPaid Family LeaveSocial impact volunteer time and donation matchesCatered lunches in the officeWe are proud to be an Equal Employment Opportunity and Affirmative Action employer. Do you want to be part of Boston’s hottest up and coming startup? Insurify is one of the fastest-growing MIT FinTech startups and has been recognized as a global Top 100 InsurTech company.
CMC Technical Writer (Contract-to-Perm)
Company: Vedanta Biosciences
Location: Cambridge
Posted Oct 05, 2023
Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.Our Vision:We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortiaVedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Title: CMC Technical Writer (Contract-to-Perm)Location: Cambridge, MAReports to: Director, CMC Operations & Strategic Planning The Role:This position will lead and assist in the writing and editing of technical documents such as investigations, whitepapers, protocols, technical reports, and regulatory submissions to make these documents as clear as possible and tailor them to the appropriate audience. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. The individual must have a clear understanding of CGMP and current regulatory expectations within the life sciences industry.Here’s What You’ll Do:Partner with technical leadership and cross-functional partners such as Manufacturing, Quality, Process Development, Validation, and Facilities to implement appropriate written documentation.Integrate various sources of information into a uniform style and language for GMP and regulatory compliance.Work with initiators to rewrite, clarify, or reconstruct controlled documents and investigations.Write and edit standard operating procedures, test methods, technical/validation reports, regulatory submissions, investigations, and other related documents.Coordinate the review, approval, and revision of procedures, specifications, and forms.Requirements:Bachelor’s Degree and minimum 5 years of experience in technical writing within the life sciences/GMP environmentMinimum of 2 years’ experience with quality management systems and processes.Experience authoring and reviewing standard operating procedures, deviations, regulatory materials, training, and other controlled documents.Advanced proficiency using Microsoft Word.Ability to collaborate effectively; strong interpersonal skills and ability to work with colleagues that possess varying levels of writing proficiency.Experience with training others in writing/editing best-practices.Why join Vedanta BiosciencesVedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes.
Head, General Manager, US Commercial Markets
Company: Amylyx
Location: Cambridge
Posted Sep 27, 2023
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. Proven track record of success in driving sales and marketing strategies within the US pharmaceutical market.Demonstrated ability to build cross-functional teams and recruit, develop, and retain top talent.Prior experience leading in a matrix environment across sales, marketing, market access, patient services/advocacy, and medical affairs to deliver results.Prior product launch experience is a must; rare disease and Neurology experience preferred. Strong preference for experience in a global organization, helping to drive the evolution of Commercial structure as pipeline expands.Solid understanding of market access and how to integrate access strategies across the US to achieve positive results.Understand the importance and impact of external key stakeholder relationships including KOL, HCP, Payers, and provide oversight of key strategies needed to ensure patient access.Demonstrated ability and desire to build a culture of cross-functional collaboration and communication, building a mindset of “if we do what’s right for patients, the profits will follow”.Operates with professionalism and sensitivity to working with people, internally and externally, from a broad range of cultures and diverse backgrounds.Must be confident and inclusive, have well-honed presentation skills and the ability to collaboratively influence peers and executive leadership. Provide oversight of field targeting, call planning/alignments, size and structure, and incentive compensation.Ensure establishment of critical KPIs in each commercial functional group. Proactively monitor metrics to identify trends and translation of trends into adjustment in strategies and tactics, share key findings having a cross-functional implication for course adjustment and alignment. Establish a close and effective collaboration with Medical Affairs to ensure field coordination and apply compliant and quality requirements to all initiatives.Collaborate seamlessly with Global Marketing, Global Patient & Professional Advocacy and Global Market Access teams to ensure alignment of and consistency with global standards.Work in partnership with Legal and Compliance, Regulatory, and other internal stakeholders to ensure tactics and operations are developed and executed in compliance with legal, regulatory, and financial guidelines.In partnership with Commercial Operations, contribute to the continued evolution of sales force systems, data, training programs, performance metricsAttract, mentor, and develop top commercial talent, nurturing a high-performing team focused on achieving ambitious goals and driving professional growthREQUIREMENTS Bachelor’s Degree required. Demonstrated ability to present at all levels including board of directors.Ability to operate effectively in a rapidly growing organization; comfortable with ambiguity and demonstrates exceptional leadership skills by confidently guiding the team through uncertain situations, maintaining a positive outlook, and fostering a collaborative and resilient atmosphere.Ability to travel at least 50%.LOCATIONThe ideal location is Cambridge, Massachusetts – candidates outside Massachusetts must be willing to travel to Cambridge on a regular basis in addition to US field travel as needed. To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. An advanced degree in Business, MBA or similar is preferred.Minimum 20 years’ experience in progressively more senior commercial leadership in the biotechnology and pharmaceutical industry including working in a matrix organization, management of a US P&L and leadership of customer facing teams including sales and market access. This entails exceptional leadership to drive alignment and results across US Sales, Marketing, Market Access, Patient Services (ACT) and Operational teams.Fosters the Amylyx values, culture and ways of working and ensures they are embedded across the US Commercial organization. Establish appropriate sales targets and objectives, partnering with Finance and Commercial Ops on revenue projections and reporting. The ideal candidate will have a track record of prior experience as the top commercial leader launching rare disease products in the US.RESPONSIBILITIESProvide leadership, direction, and development to the US Commercial organization, establishing the vision, objectives, and strategic plan for customer-facing teams. Partner with Commercial Operations to ensure optimal business planning.
Principal Scientist, DMPK
Company: Montai Health
Location: Cambridge
Posted Oct 09, 2023
Montai Health, a biotechnology company, is seeking a DMPK scientist to support its Drug Development team. The company aims to transform healthcare and sustainability through innovative technologies. Montai fosters a culture of excellence, collaboration, and diversity. The ideal candidate will have a Ph.D., extensive DMPK experience, and strong analytical skills. They will work closely with the Sr. Director, DMPK, and contribute to lead optimization and candidate selection.
Sr Site Specialist
Company: Thermo Fisher Scientific
Location: Cambridge
Posted Sep 19, 2023
StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Informs site employees of special customer requirements, resolves problems and keeps employees informed of corrective action.Provides technical support to customer and specialists regarding special systems, products or procedures.Performs other duties as assigned. Acts as a liaison between customer, sales, suppliers, logistics and management using special system knowledge to ensure success of customer relationships. Services may include the portfolio of services provided including order entry, order management, operating customer procurement systems, stockroom services, material handling, shipping/receiving, chemical tracking, and glass wash operations. Experience Hands-on laboratory experience: previous experience in automated sample testing or sample testing preferred, but not required Knowledge, Skills, Abilities Demonstrated verbal, written and presentation skillsDisplays a high level of confidentiality for both customer and Thermo Fisher.Must maintain Thermo Fisher Scientifics' Four-I ValuesProven excellence in customer service skills.Detail oriented, problem solver, promotes team environment.Must possess a strong desire to serve the customer, and the social skills to deal with various levels of personnel at the customer site.Must deliver excellent customer service to include always maintaining a professional appearance.Must possess the operating skills to use hand held scanners and learn to enter data in various systems as necessary.Must be proficient with a computer and the Microsoft Office suite of software.Demonstrates basic leadership concepts.Have demonstrated initiative in previous work experience.Show concern for wellbeing & success of others.Must possess a high level of interpersonal skills to provide guidance to others in performing the work, to effectively present information and respond to questions or customer service requests and interact with various levels of the customer's organization.Provide suggestions for corrective action and preventive customer service. Expertise should include:Knowledge of customer service agreement, service level agreements and relevant systemsWork instructionsStandard Operating ProceduresStandard MethodologiesAdopts PPI methodologies.Works effectively with a diverse cross functional team.Performs as a Senior Site Specialist, Site Specialist or Site Technician.Answer customer questions and responds to/resolves problems.Meets with customers proactively to help determine ongoing needs. Watch as our colleagues explain 5 reasons to work with us. Keys to Success: Education High school diploma or equivalent required.
Engineering Manager
Company: 2seventy bio
Location: Cambridge
Posted Sep 21, 2023
(i.e Change Control, Deviations, CAPA, SOP’s, Audit support)Author SOP’s governing operation and maintenance practices for responsible systems.Establish and maintain the Company Asset Register and Maintenance Plans governing reliability and compliance for responsible systems.Identify, solicit, and negotiate contracts with service providers as needed for technical suitability and cost-effectiveness.Lead investigations and remedial plans at the site for significant equipment failures and process improvements.Maintain up-to-date instruction manuals, spare parts lists, schematics, drawings, etc. In accordance with 2seventy bios duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees, contractors, consultants and their families, and the community at large from infections disease that may be reduced by vaccinations. Experience with Siemens BMS, Rees Scientific is an advantageExperience with a CMMS is required. Experience with Blue Mountain is an advantageMust be self-motivated and able to work on multiple tasks with a minimum of supervisionAbility to communicate effectively 2seventy bio has a mandatory vaccination policy for the COVID-19 vaccination for all employees, contractors and consultants as of January 4, 2022. How you’ll make an impact:Facilities at 2seventy bio includes 250,000SF of office, R&D lab, clinical manufacturing suites and commercial QC labs in Cambridge, along with 35,000SF of R&D/office space in Seattle.This role is to provide 2seventy with engineering leadership and technical subject matter expertise across all engineering systems (both locations with a primary focus on Cambridge) to ensure business critical systems are designed, installed, qualified and maintained correctly delivering reliable operations for all 2seventy manufacturing and R&D activities.The position will develop, improve and maintain all engineering guidelines, SOP’s, maintenance plans and other documentation to ensure 2seventy’s compliance with all regulatory standards for our growing GMP operations and R&D activities.How you’ll spend your time:This role will serve as the Business & Technical System Owner for all Facilities Systems (Mechanical, Electrical, Plumbing + Controls). 2seventy bio may consider several factors in assessing whether an exemption is available through an interactive process. on all systems and equipment.Own the review and acceptance of newly installed and commissioned equipment and systems to ensure that all systems are designed and operating properly prior to acceptance.Deliver a strategic approach to Life Cycle Asset Management, ensuring consistent adoption and appropriate planning for capital replacement cycles.Who you are and what you’ve accomplished:Requires a Bachelor's degree in sciences or engineering-related fieldsAt least 7+ years of relevant experience in facilities / engineering position with a strong technical knowledge of HVAC, Lab Gases and Electrical is requiredAt least 3+ years of experience working in a Biotech/Pharmaceutical GMP setting is require, working with GMP processes and related documentationAt least 2+ in a role as Technical SME, troubleshooting MEP problemsExperience with facilities control and monitoring systems is required. Additional vaccinations beyond the Covid-19 vaccine may be added in the future. Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department. All requests for an exemption will be evaluated on an individual basis. This position will interact with a wide stakeholder base internally and externally to Facilities.Inform and influence the development of GxP strategy and policy and Infrastructure Engineering management; leadership in GxP regulatory compliance across all 2seventy sites, in full alignment with corporate business strategies.Lead the delivery of GxP engineering needs for FDA/MHRA/EMEA compliant facilities within 2seventy bio.Ensure that processes and systems for the Infrastructure Engineering services meet all national, corporate and local regulations in the area of regulatory and statutory compliance with a strong focus on cGMP.Understand industry trends and developments maintaining an external and cross-business awareness thinking broadly and strategically regarding issues relating to Infrastructure Engineering services so as to drive the delivery of best practice.Establish reliability key performance indicators that ensure that the Infrastructure Engineering services are meeting the overall delivery strategies.Provide technical consultancy across the wider Facilities organization in core discipline as required, and utilize external providers for detailed technical assessments as necessary.Take responsibility as the system owner of multiple complex infrastructure systems used throughout the facility.Oversee the delivery of control systems support for critical cGMP data acquisition, alarm, building management and environmental monitoring systems.Ownership for all quality related items associated with infrastructure equipment and systems.