Director, REMS Global Safety Sciences, Medical Safety and Risk Management
Agios Pharmaceuticals 4.5
Remote Agios Pharmaceuticals job
Director, REMS Global Safety Scientist, Medical Safety and Risk Management Who we are:At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve.
We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate.
Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built.
To learn more, visit www.
agios.
com and follow Agios on LinkedIn and X.
The impact you will make:Agios Pharmaceuticals is searching for a dynamic Director, REMS (Risk Evaluation and Mitigation Strategy) Global Safety Scientist, to join our growing Medical Safety and Risk Management team.
We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities.
The Director, REMS Global Safety Scientist will be responsible for monitoring, evaluating, and managing the safety profile of assigned products, with a specialized focus on risk minimization activities required by global regulatory agencies such as the FDA and EMA.
The ideal candidate will leverage strong scientific writing, analytical skills, and regulatory expertise to ensure product benefits continue to outweigh their risks in both clinical trial and post-marketing environments.
What you will do:Lead the authoring, development, and ongoing maintenance of REMS materials Lead the scientific review and authoring for REMS assessment reports Provide vendor oversight as needed Collaborate cross-functionally for internal review of the full REMS assessment reports Author, contribute to, and strategically review aggregate safety reports overall and with a specific focus to REMS requirements and risks that require REMSSupport readiness for internal audits and external regulatory inspections related to REMS activities Organize, direct and manage technical and human resources to efficiently support the management of REMS safety data in accordance with FDA safety regulations Liaise with safety systems for required outputs Collaborate with medical risk management function Drive timely decisions and appropriately shift functional timelines, resources and priorities Other Safety Scientist Responsibilities:Conduct signal detection and management activities Develop and maintain risk management plans Manage direct report performance against goals; supporting and consulting as necessary Serve as functional owner of SOPs and Work Instructions related to functional area Serve as a point of escalation for issue resolution What you bring:Health care professional (e.
g.
RN, pharmacist, or other life sciences experience) with a minimum of 6 years of relevant drug safety/pharmacovigilance experience; training in pharmacology, epidemiology or regulatory science is a plus Able to oversee and manage direct reports and vendors Excellent written/verbal communication and interpersonal skills Strong planning and organization skills Strong analytical skills and the ability to interpret complex clinical and safety data Excellent scientific writing and communication skills, with attention to detail Ability to work independently, manage multiple projects simultaneously, and collaborate effectively in a team environment.
Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table.
We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work.
If you're excited about this role but your previous experience doesn't align perfectly with the , we still encourage you to apply.
You may be just the right candidate for this role or another opening! Work Location:Location Agnostic: Work location for this role is based on employee's individual preference.
This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters.
Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters.
Remote employees work entirely from home except for attending Company sponsored events/ meetings.
For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:Deliberate Development.
Your professional growth as one of our top priorities.
Flexibility.
We're all about individual needs.
We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity.
When you're at your best, we're at our best.
Premium benefits package.
We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
Competitive and equitable performance-based compensation.
This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
The current base salary range for this position is expected to be between $183,549 - $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Psychological safety.
We support an environment of fearlessness.
We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
Commitment to diversity.
We strive to foster a welcoming workplace where everyone can thrive.
We're continuously looking to improve the inclusivity of our workforce.
Commitment to community.
We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
$183.5k-275.3k yearly 13h ago
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Manager, Clinical Data Analytics
Agios Pharmaceuticals 4.5
Remote Agios Pharmaceuticals job
Manager, Clinical Data Analytics Who we are:At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve.
We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate.
Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built.
To learn more, visit www.
agios.
com and follow Agios on LinkedIn and X.
Job Description:The Manager, Clinical Data Analytics will manage, contribute, and support the integration of different clinical systems data into clinical data warehouse/ data review / analytics platform to enhance efficiencies in collaboration with key stakeholders for cross-functional data review.
Design, develop and maintain data mappings, data rules, and data transformations to populate clinical data warehouse with source data to provide one data review reporting/analytics solution for the cross functional stakeholders.
Serve as a subject matter expert and provide expertise for study database development, reporting data mapping programming.
Provide expertise on problem-solving with clinical data, functionality and capabilities.
Provide input into assessment of new technologies, collaborates with cross-functional teams, IT and QA for implementation, validation and rollout as necessary.
Partner with IT and QA to test and implement system upgrades for elluminate system.
Support development of departmental SOPs and processes.
Provide application administration and technical support for tools such as elluminate, spotfire, SQL Server or other reporting tools.
Perform programming, testing, mapping, data feeds and documentation in accordance with programming standards and validation procedures using reporting tools such as elluminate Data Central, spotfire, SQL server or other reporting tools to support the study teams.
Program and generate data review tools such as patient profiles and targeted data listings in support of data review.
Work with clinical trial project teams and management to adhere to quality standards and project timelines.
Telecommuting available anywhere in the United States.
Job Requirements:Requires at least Bachelor's degree or foreign equivalent in Computer Science, Computer Information Technology, or a related field.
Must possess 5 years of progressive postbaccalaureate experience with all of the following: (a) pharmaceutical industry experience performing reporting and analytics programming and data warehouse management; (b) performing programming, testing, mapping, and creating data feeds and documentation using SQL Server; (c) working with clinical databases; (d) creating data visualization using Spotfire (e) working with relational databases SQL Server, MySQL, and Oracle; (f) data reporting and programming in SQL and PL/QL; (g) loading eCFR data from electronic data capturing system and cleaning data; and (h) working with regulatory guidelines including GCP/ICH, FDA/EMA/CHMP, and 21 CFR Part 11.
Experience may be gained concurrently.
Telecommuting available anywhere in the United States.
What we will give you:Deliberate Development.
Your professional growth as one of our top priorities.
Flexibility.
We're all about individual needs.
We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity.
When you're at your best, we're at our best.
Premium benefits package.
We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
Competitive and equitable performance-based compensation.
This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
The current base salary range for this position is expected to be between $161,803 - $165,044 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Psychological safety.
We support an environment of fearlessness.
We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
Commitment to diversity.
We strive to foster a welcoming workplace where everyone can thrive.
We're continuously looking to improve the inclusivity of our workforce.
Commitment to community.
We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
#LI-DNI
$161.8k-165k yearly 13h ago
Health Screener
Biolife Plasma Services 4.0
West Springfield Town, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
Phlebotomist
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will greet donors as they enter and exit the donor floor.
· You will perform venipuncture of donors and programming of plasmapheresis machine.
· You will monitor donors during the donation process and manage donor reactions.
· You will perform all tasks required for the setup, verification, operation, and troubleshooting of plasmapheresis equipment within scope of training.
· You will install, prime, and disconnect disposable sets on the plasmapheresis machines
· You will stock supplies, break down empty cartons and assist with proper disposal.
· You will take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system.
· You will perform finger sticks, test sample, and record other donor measures to include hematocrit, total protein, and weight.
· You will enter donor information into the Donor Information System (DIS).
· You will coordinate donors to donor floor and compensate donors using the Debit Card system.
· You will support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes through use of company approved procedures including 5S, Value Stream Mapping and Kaizen.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - West Springfield
U.S. Starting Hourly Wage:
$19.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - West SpringfieldWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$19 hourly Auto-Apply 1d ago
Entry Level Plasma Center Technician
Biolife Plasma Services 4.0
West Springfield Town, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - West Springfield
U.S. Starting Hourly Wage:
$18.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - West SpringfieldWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$18 hourly Auto-Apply 1d ago
Entry Level Phlebotomist - Bilingual
Biolife Plasma Services 4.0
West Springfield Town, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
Phlebotomist
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will greet donors as they enter and exit the donor floor.
· You will perform venipuncture of donors and programming of plasmapheresis machine.
· You will monitor donors during the donation process and manage donor reactions.
· You will perform all tasks required for the setup, verification, operation, and troubleshooting of plasmapheresis equipment within scope of training.
· You will install, prime, and disconnect disposable sets on the plasmapheresis machines
· You will stock supplies, break down empty cartons and assist with proper disposal.
· You will take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system.
· You will perform finger sticks, test sample, and record other donor measures to include hematocrit, total protein, and weight.
· You will enter donor information into the Donor Information System (DIS).
· You will coordinate donors to donor floor and compensate donors using the Debit Card system.
· You will support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes through use of company approved procedures including 5S, Value Stream Mapping and Kaizen.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - West Springfield
U.S. Starting Hourly Wage:
$19.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - West SpringfieldWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$19 hourly Auto-Apply 1d ago
Remote MSL: Osteoporosis Expert (Senior)
Upsher-Smith 4.7
Remote or Waltham, MA job
A biopharmaceutical company is seeking a Medical Science Liaison/Senior Medical Science Liaison based in the Dallas/Fort Worth metro area. This role involves developing relationships with healthcare leaders to improve health outcomes in osteoporosis. The ideal candidate will have a doctorate and experience in the sector. Key responsibilities include scientific communication, collaboration with stakeholders, and supporting research initiatives. The compensation range is competitive, reflecting experience and qualifications. This position requires up to 70% travel and offers a flexible remote work environment.
#J-18808-Ljbffr
$93k-147k yearly est. 3d ago
Strategic Operations Lead, US Market Access
Vertex Pharmaceuticals 4.6
Boston, MA job
A global biotech company is seeking an Associate Director for Strategy and Operations in Boston. This role supports the US Market Access Leadership Team, driving strategic initiatives and operational execution. The ideal candidate will have over 8 years of experience, strong communication and collaboration skills, and a Bachelor's degree. The position offers a hybrid or on-site work model and competitive compensation ranging from $155,700 to $233,600 annually, with additional benefits such as educational support and paid time off.
#J-18808-Ljbffr
$155.7k-233.6k yearly 1d ago
Director, Safety Scientist
Astrazeneca 4.6
Boston, MA job
The Director, SafetyScientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework.
You will be responsible for:
Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:
Proven skill set for strategic leadership in a cross functional matrix
Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications
Co-lead activities related to new drug applications and other regulatory filings
Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc.
Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation
Leading activities to identify and address process gaps
Responsible for vendor management and training including budgets
Responsible for overall project distribution across therapeutic area
As needed represent GPS in global program teams and associated cross functional teams and/or projects
Proactively provide guidance and educational training to GPS therapeutic teams
Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors.
Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration safety physicians.
Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products.
You will have:
Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry
Knowledge and understanding of US and EU safety regulations pre- and post- marketing
Experience with Risk Management and Minimization programs
Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans
Experience with clinical development including risk/benefit analysis and safety assessment
Strong clinical, analytical, problem solving and scientific writing and communication skills
We would prefer you have:
Expertise with clinical and safety databases
Experience in MedDRA coding and search strategies
Excellent, independent judgment based on knowledge and expertise
Strong personal time-management and project-management skills
Mastery of Microsoft Word, PowerPoint and Excel
The annual base pay for this position ranges from $175,000 to $263,000. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
02-Dec-2025
Closing Date
16-Dec-2025
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr
$175k-263k yearly 4d ago
Project Management & Strategic Operations Director
Vertex Pharmaceuticals 4.6
Boston, MA job
Project Management & Strategic Operations Director page is loaded## Project Management & Strategic Operations Directorlocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27588**Job Description****General Summary:**The Project Management & Strategic Operations Director - Clinical Development serves as the end-to-end program lead for large-scale strategic programs of high business value. Drives benefit achievement by leading program initiation, planning, solution design and build, and by measuring key performance indicators and solution adoption. Engages other colleagues/resources and assigns appropriate responsibilities to support achievement of program roadmap and project plan(s). Independently applies expert knowledge of advanced methodologies, selecting and applying high-level project management tools to conduct analyses, reporting and related activities for assigned projects. Contributes to the development of internal protocols and processes used to carry out program management work. Responsible for program management activities including contingency/dependency tracking, status reporting, issue/risk identification and tracking, scope management, estimation, and internal/external stakeholder management. Provides oversight to workstream/task leads within the program; resolves any escalated project risks, issues and dependencies. Manages the overall scope and timing of the program, ensuring on-time and within budget delivery.This role will serve an important role in the Global Clinical Development organization to improve focus and alignment across programs and ensure greater organizational effectiveness. Responsibilities will include working with other functions within Vertex to obtain accurate, up-to-date plans and metrics across all clinical development programs to ensure visibility and alignment, including study milestones, enrollment metrics and budgets.**Key Duties and Responsibilities:*** Organizing, driving and managing the Clinical Development deliverables in terms of timelines, budget and communication.* Serve as a strategic partner to the SVP, Clinical Development; create and run reports, create presentations, draft communications documents, serve on cross-functional strategic initiatives representing Clinical Development.* Support the SVP, Clinical Development in creating, communicating and tracking annual goals* Partner with Clinical Development Execution group to use the clinical operations systems to track study enrollment across programs vs target and translate the information to make it relevant and user friendly for Clinical Development.* Work with finance, clinical development execution team and medical directors to track study budgets across programs vs target* Collaborate with regulatory team to use the regulatory systems to track upcoming regulatory meetings and briefing documents (drafts/review schedule etc) and translate to make this information to make it relevant and user friendly for Clinical Development* Run the TA review meetings including meeting minutes, tracking and archiving submissions and decisions* Drive executional excellence in terms of timelines, sign-offs, submissions to internal governance (eg protocols, CSRs, etc) and external postings like clinical trials.org* Support onboarding, compliance/SOP training and tracking, team effectiveness* Lead communications within the Clinical Development team including updates within the team, to cross-functional partners including those ex-US, and bring relevant communications from the broader organization in to ensure the Development area are aware and prepared* Oversees end-to-end program management activities for large-scale, strategic programs of high business value, with oversight for the full project lifecycle* Manages the progress and contributions of workstream leads or subordinate project managers to ensure all activities deliver expected value within committed timeframes and budget* Manages contingencies between multiples projects and monitors interdependencies and synergies where required* Builds and synthesizes highly-detailed project plans, budgeting & forecasting models or resource plans, requiring significant stakeholder management skills and interpretation of diverse and varied information* Develops statements of work, stakeholder management plans, guiding principles, project goals, risks, resource allocation, and roles and responsibilities for assigned projects* Secures, leads, motivates and inspires the internal and external resources required to effectively deliver the program. Establishes the program's governance (e.g., sponsors, approvers, stakeholders)* Participates in the evaluation, selection and management of external resources or vendors* Provides transparency in project progress and effectively anticipates and mitigates major risks across the project lifecycle* Proactively crafts feasible solutions to combat risks and issues. Exercises sound judgement balancing risks and making prompt decisions in ambiguous or difficult situations* Manages communication with management at a detailed functional level and discusses/resolves issues* Works with all required functions and groups to effectively plan and execute the program/project(s). May coordinate resources across organizational boundaries* Trains and coaches project teams in execution methodologies and promotes adoption of best practices* Develops tools and training methods to enable successful project management throughout the enterprise. Ensures project delivery is in conformance with company methodologies and standards; recommends improvements and changes as necessary* Evaluates program costs and benefits including actual results and forecasts with comparisons to original or baseline plan and updates plans with accurate, up-to-date information in a timely manner. Reports financial information and status to leadership. Ensures program solution(s) meets quality and reliability requirements and that the launch approach meets or exceeds adoption targets. Monitors program results/performance for significant deviations, evaluates options and makes recommendations for corrective actions, and then implements selected actions**Knowledge and Skills:*** Some education, training or experience in biology/chemistry/engineering desirable* Drug Development knowledge and/or project management experience preferred* Proven experience in cross-functional execution including medium to large-scale projects* Critical thought partner and proven ability to connect people and ideas to drive outcomes* Demonstrated ability to connect with over divisions and functions throughout Vertex* Ability to manage multiple priorities/projects at a given time, ensuring deadlines, budgets and status updates* Highly developed communication skills and the ability to synthesize data and information into meaningful insights* Very detail oriented and strong project/operation management skills* Ability to handle ambiguity**Education and Experience:*** Bachelor's degree* Typically requires 10 years of experience or the equivalent combination of education and experience**Pay Range:**$183,800 - $275,700**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
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A leading biotechnology company in Boston is seeking an experienced Senior Director, Finance Technology to drive innovation across Financial Systems, focusing on Tax, Treasury, and Accounting. The ideal candidate will have over 12 years of experience in financial systems leadership, strong stakeholder engagement skills, and a passion for technology. This role offers competitive compensation and hybrid work options.
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$71k-96k yearly est. 1d ago
Hybrid HCP Marketing Associate Director
Vertex Pharmaceuticals 4.6
Remote or Boston, MA job
A leading biotechnology company in Boston seeks an HCP Marketing Associate Director to develop and execute marketing strategies. The ideal candidate will have significant experience in pharmaceutical marketing, strategic planning, and strong analytical skills. Responsibilities include collaborating on brand strategies, overseeing agency partnerships, and measuring marketing effectiveness. A Bachelor's degree and at least 8 years of experience are required. This position offers a hybrid or on-site work model and a competitive salary range of $162,800 - $244,200.
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$162.8k-244.2k yearly 2d ago
External Innovation Executive Director
Vertex Pharmaceuticals (San Diego) LLC 4.6
Remote or Boston, MA job
The External Innovation (EI) Executive Director leads end‑to‑end identification, evaluation, and advancement of external opportunities that materially strengthen Vertex's R&D pipeline across modalities (e.g., small molecules, biologics, CGT, RNA, delivery platforms) and enabling technologies (e.g., discovery, translational, and manufacturing tools). The role orchestrates integrated, cross‑functional analyses and converts opportunity signals into clear, decision‑ready recommendations for EI governance (EI Science, BDSC) and the Executive Committee. Culture & talent: Foster an environment consistent with EI competencies (business‑minded leader, insight generator, influential communicator, trusted partner, change enabler, technical expert).**Required Education:** PhD (or equivalent advanced degree) and 15+ years of biotech/pharma experience spanning discovery and/or early development; or an equivalent combination of education and experience.**Required Experience**Proven ability to build and manage high‑performing analyst teams and to operate an integrated analysis model. **Required Knowledge & Skills**Business acumen: Valuation literacy; option‑value framing; scenario and risk modeling; ability to articulate value drivers and deal concepts (from partnerships to company creation/M&A). Influential communication: Executive‑quality narratives and visuals; clear storyline from problem framing to recommendation; ability to lead with facts and secure alignment. The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.
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$158k-229k yearly est. 3d ago
Senior Consumer Media Strategy Lead - Kidney Health (Hybrid)
Vertex Pharmaceuticals 4.6
Remote or Boston, MA job
A global biotechnology company is seeking an Associate Director, Consumer Media Strategy & Execution to lead media strategies and enhance digital presence in the US Kidney Business Unit. The role requires a strong background in media planning, buying, and analytics. Candidates should have excellent leadership skills and be capable of collaborating with cross-functional teams. The position offers flexibility to work either hybrid or on-site, with a competitive benefits package including bonuses and educational assistance.
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$113k-150k yearly est. 5d ago
Sr. Manager,Safety Operations / Case Management, Medical Safety and Risk Management
Agios Pharmaceuticals 4.5
Remote Agios Pharmaceuticals job
Sr. Manager, Safety Operations / Case Management, Medical Safety and Risk Management Who we are:At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve.
We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate.
Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built.
To learn more, visit www.
agios.
com and follow Agios on LinkedIn and X.
The impact you will make:Agios Pharmaceuticals is searching for a dynamic Sr.
Manager, Safety Operations/Case Management to join our growing Medical Safety and Risk Management team.
We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities.
The Sr.
Manager, Safety Operations / Case Management will be responsible for overseeing the execution of deliverables associated with case processing, expedited reporting and submission of designated aggregate safety reports, with a specialized focus on risk minimization activities required by global regulatory agencies such as the FDA and EMA.
This position ensures individual reports from all sources (spontaneous, literature, product/patient support programs, market research programs, clinical trials (pre-& post approval), medical information, call centers, commercial affiliates, partner companies, health authorities, post marketing commitment studies, etc.
) are collected, managed and reported according to Agios' global SOPs and global adverse event regulations and guidelines.
This position oversees case processing activities, processes, procedures, and interdepartmental projects involving safety data captured in the global safety database.
This position collaborates within MSRM and with other company functional areas and cross-functional teams, and interacts with CROs, vendors, partners, and study teams on all aspects of safety data collection and reporting.
What you will do:Contribute to the authoring, development, and ongoing maintenance of REMS materials Participate cross-functionally in the internal review of REMS assessment reports Conduct and monitor reconciliation activities related to the reporting of REMS safety events to AgiosTrack and ensure follow-up of specified safety events utilizing the Liver Adverse Event Report Form (LAERF) Ensure processing and expedited submission of safety events in accordance with REMS enhanced pharmacovigilance requirements Conduct and monitor reconciliation activities related to the reporting of REMS safety events to AgiosOrganize, direct and manage technical and human resources to efficiently support the capture and management of REMS safety data in accordance with FDA safety regulations and ICSRs in accordance with global regulations and standards Contribute to signaling and aggregate reporting activities of REMS and other safety data through ensuring quality and accuracy of individual cases through collaboration with Global Safety Sciences Ensure development and delivery of REMS-related training materials for case management vendor and safety operations team Support internal audits and external regulatory inspections related to REMS activities Contribute to safety database upgrades and configuration changes; perform user acceptance testing Collaborate internally and with vendors to establish and monitor key performance indicators (KPIs) that are relevant and in alignment with regulations/industry standards Provide subject matter expertise and collaborate with MSRM Standards, Compliance and Training colleagues, Pharmacovigilance Quality Assurance colleagues and vendors to ensure compliance with world-wide regulations for case quality and timely submissions Support MSRM and cross-functional compliance activities through the compilation and delivery of compliance metrics at required intervals/frequencies Represent the functional area in internal committees and with external parties (e.
g.
partners, regulatory agencies) Serve as a point of escalation for issue resolution Drive timely decisions and appropriately shift functional timelines, resources and priorities What you bring:BS/BA with health care professional (e.
g.
RN, pharmacist) or other life sciences experience Minimum of 3-5 years of relevant drug safety/pharmacovigilance experience Strong knowledge of FDA REMS requirements Knowledge of current industry standards and benchmarks Able to oversee and manage vendors Extensive experience with MedDRA and WhoDD coding dictionaries Experience with software-based drug safety systems (eg: ARGUS, ARISg) Excellent computer skills (MS Office) Advanced knowledge of US and EU pharmacovigilance regulations for development and marketed products Strong planning, process mapping, and organization skills Strong orientation to teamwork Strong negotiation skills to effectively drive discussions and decisions to achieve desired end-results Excellent written/verbal communication and interpersonal skills Preferred:Audit and/or inspection experience in REMS and/or pharmacovigilance Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table.
We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work.
If you're excited about this role but your previous experience doesn't align perfectly with the , we still encourage you to apply.
You may be just the right candidate for this role or another opening! Work Location:Location Agnostic: Work location for this role is based on employee's individual preference.
This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters.
Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters.
Remote employees work entirely from home except for attending Company sponsored events/ meetings.
For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:Deliberate Development.
Your professional growth as one of our top priorities.
Flexibility.
We're all about individual needs.
We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity.
When you're at your best, we're at our best.
Premium benefits package.
We invest in the health, wellbeing and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
Competitive and equitable performance-based compensation.
This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
The current base salary range for this position is expected to be between $131,035 - $196,553 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Psychological safety.
We support an environment of fearlessness.
We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
Commitment to diversity.
We strive to foster a welcoming workplace where everyone can thrive.
We're continuously looking to improve the inclusivity of our workforce.
Commitment to community.
We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
$33k-47k yearly est. 13h ago
Finance Systems & Reporting Excellence Director
Vertex Pharmaceuticals 4.6
Boston, MA job
A leading biotechnology company is seeking a Director, Global Process Excellence to enhance finance systems and processes integral to scaling operations. This role requires extensive finance experience, capability in project management, and leading cross-functional improvements. The position offers a hybrid work model and competitive salary range of $180,800 - $271,100, along with generous benefits and annual bonus eligibility.
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$180.8k-271.1k yearly 4d ago
Senior / Staff / Principal Embedded Software Engineer
Nia Therapeutics 3.3
Boston, MA job
At Nia Therapeutics, we are engineering solutions at the frontier of neuroscience to make memory loss reversible.
We are a team of scientists and engineers developing advanced implantable brain stimulation devices to reverse memory loss from brain injury and degenerative disease. Our core technology, developed at the University of Pennsylvania and funded by DARPA, is built on a foundation of human clinical studies that demonstrate its efficacy. This is a rare opportunity to help develop a product that will not only improve patient lives but also redefine what's possible in neural engineering.
WHAT YOU WILL DO
Develop embedded firmware in C to support BLE communication between an implantable device and mobile apps
Design and implement custom GATT services and characteristics to enable secure, low-latency data exchange
Support real-time signal processing, sensor interfaces, and closed-loop control logic
Contribute to the design of system-level communication protocols across implant, wearable, and cloud platforms
Help build automated test systems for wireless and embedded functionality
REQUIRED QUALIFICATIONS
BS in Electrical Engineering / Computer Science plus 5+ / 8+ / 11+ years experience OR an advanced degree plus 3+ / 6+ / 9+ years of experience
Strong programming skills in C for embedded systems
Hands‑on experience developing and debugging BLE firmware, including custom profiles and characteristics
Understanding of BLE stack behavior (advertising, connection parameters, bonding, encryption)
Comfortable working with microcontroller toolchains, oscilloscopes, and logic analyzers
Ability to read datasheets and electrical schematics and develop device drivers
Strong troubleshooting, communication, and cross‑functional collaboration skills
PREFERRED SKILLS
Experience with ST or Nordic microcontrollers
RTOS based firmware development (e.g. FreeRTOS, Zephyr)
Hands‑on experience developing and debugging Bluetooth Low Energy (BLE) communication protocols, including creating custom GATT services and characteristics
Experience integrating mobile applications with embedded firmware, ensuring robust and reliable data exchange
Experience developing active implantable medical devices, medical device quality systems, standards (e.g. ISO-14708) and risk management activities (e.g. FMEA)
Proficiency in cross‑platform (Android, iOS) mobile application development
Broad circuit design experience including analog, digital, power supply and comms functions
Setting up and maintaining testing environments for hardware and software systems
OUR CULTURE
This position is 5 days per week in person based in Boston, MA. We're a small team tackling big challenges. We move quickly, think rigorously, and care deeply about the impact of our work. If you're excited by the idea of helping build a product that integrates neuroscience, embedded systems, and mobile UX, and you're eager to grow in a fast‑paced startup, we'd love to meet you.
BENEFITS
Nia Therapeutics provides comprehensive health benefits to support our employees' well‑being, including medical, dental, and vision insurance. We also offer stock options, giving team members a direct stake in the company's success and long‑term mission.
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$106k-132k yearly est. 3d ago
Director, Order Management Operations - Heme
Vertex Pharmaceuticals 4.6
Remote or Boston, MA job
develops and provides strategic direction and leads daily operations of the US care management team supporting the US, Heme Business Unit. This individual will represent the US on the global cross-functional manufacturing team, developing slot allocation policies, managing exceptions processes, and managing system/manufacturing capacity. This individual will also play a key role in ensuring exceptional support is provided to our customers by our care manger team. This critical role will be highly cross functional within Vertex with the goal of providing industry-leading patient support through patient facing interactions and logistical coordination.Exceptional leadership and collaboration skills, as well as a strategic mindset are essential to the role. Strong partnerships will be required with internal functions such as finance, supply chain, manufacturing, IT, and other commercial colleagues. This individual will report to the Head of US Heme Patient Support. **Key Responsibilities:** Clear and consistent communication of roles, responsibilities, and performance expectations Daily monitoring to ensure consistent execution of all program requirements Consistent refinement and development of the CM role to ensure provision of impactful support in the logistical coordination of support activities and customer relationship development Support US OMstrategy and process optimization to ensure the processes support global OM goals and the best possible customer experience including but not limited to:System requirements (VCP and BEACON) Oversight and optimization of CM OM roles and responsibilities EHR and portal system requirements (VCP and BEACON)**Qualifications:** Strong customer service focus and the ability to act with urgency to respond to customer needs CGT experience preferred 5+ years' experience as impactful people-leader preferably in the biotech/pharma environment Excellent communication, interpersonal, and leadership skills Ability to act with urgency to ensure time-critical activities are completed while ensuring all stakeholders are on-board and have clarity around the goals and objectives Business savviness and ability to streamline processes and find opportunities for improvement Must be able to effectively work in a fast-paced environment, with strong time-management skills10+ year's work experience in the biotech/pharma environment Excellent communication, interpersonal, and leadership skills Ability to act with urgency to ensure time-critical activities are completed while ensuring all stakeholders are on-board and have clarity around the goals and objectives Ability to take complex situations and break them down into simple parts to enable stakeholders to make decisions / take actions Business savviness and ability to streamline processes and find opportunities for improvement Must be able to effectively work in a fast-paced environment, with strong time-management skills The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.
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$200k-303k yearly est. 5d ago
Health Screener $19 per hour
Biolife Plasma Services 4.0
Attleboro, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Attleboro
U.S. Starting Hourly Wage:
$19.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - AttleboroWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$19 hourly Auto-Apply 1d ago
Phlebotomist $19 per hour
Biolife Plasma Services 4.0
Attleboro, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Attleboro
U.S. Starting Hourly Wage:
$19.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - AttleboroWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Director, Risk Evaluation & Mitigation Strategy (REMS) Who we are:At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve.
We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate.
Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built.
To learn more, visit www.
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The impact you will make:Agios Pharmaceuticals is searching for a dynamic Director, Risk Evaluation & Mitigation Strategy (REMS) to join our growing Medical Safety & Risk Management team.
We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities.
The Director, Risk Evaluation & Mitigation Strategy (REMS) will be responsible for serving as the organizational lead for the design, implementation, and oversight of REMS programs.
This role combines strategic leadership, operational execution, and cross-functional collaboration.
The Director will reside within Medical Safety & Risk Management (MSRM) and work closely with Regulatory Affairs, Medical Affairs, Market Access, Commercial, Supply Chain, and Legal teams, as well as external vendors, to deliver high-quality REMS programs that meet FDA requirements and support product success.
What you will do:Strategic LeadershipLead the implementation, oversight, and evaluation of REMS in alignment with the broader Program Strategy.
Act as the in-house REMS expert across the organization.
Monitor regulatory changes and proactively update strategies, policies, and procedures to align with FDA requirements and best practices.
Partner with cross-functional teams to integrate REMS considerations into product development, launch, and lifecycle management strategies.
Cross-Functional & Matrix LeadershipResponsible for the cross functional development of implementation and operational plans that support the REMS.
Accountable for REMS management and oversight in accordance with time, cost and quality commitments.
Coordinate matrix teams across MSRM, Regulatory Affairs, Medical Affairs, Market Access, Marketing, Quality, Supply Chain, Commercial, and Legal.
Communicate REMS strategy, progress, and compliance metrics to senior management and governance committees.
Operational ExecutionEnsure timely execution of operational aspects of REMS and related activities.
Review REMS related documentation, including FDA requests, and approve vendor-authored documents as required.
Oversee vendor interactions and management of day-to-day REMS operations, ensuring compliant enrollment, data collection, monitoring, and reporting.
Support integration of call centers, technology platforms, and other operational infrastructure as appropriate.
Approve and manage program deliverables, budgets, and timelines.
Develop and oversee KPIs, dashboards, and compliance metrics to measure program effectiveness.
Ensure readiness for regulatory inspections and audits; support noncompliance issue resolution, CAPA development and execution as needed.
What you bring:QualificationsBachelor's or Advanced degree in science, pharmacy, nursing, healthcare, or related field.
10+ years of pharmaceutical/biotech industry experience, with expert knowledge and proven track record on REMS operations Proven track record in vendor management, program implementation, and compliance oversight.
Demonstrated success leading cross-functional and matrix teams.
Strong knowledge of FDA REMS requirements and evolving regulatory landscape.
Experience implementing SOPs and compliance frameworks.
Excellent communication, project management, and organizational skills.
PreferredAdvanced degree (PharmD, PhD, MSN, MPH, MBA, or related).
Audit and/or inspection experience in REMS and/or pharmacovigilance Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table.
We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work.
If you're excited about this role but your previous experience doesn't align perfectly with the , we still encourage you to apply.
You may be just the right candidate for this role or another opening! Work Location:Location Agnostic: Work location for this role is based on employee's individual preference.
This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters.
Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters.
Remote employees work entirely from home except for attending Company sponsored events/ meetings.
For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:Deliberate Development.
Your professional growth as one of our top priorities.
Flexibility.
We're all about individual needs.
We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity.
When you're at your best, we're at our best.
Premium benefits package.
We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
Competitive and equitable performance-based compensation.
This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
The current base salary range for this position is expected to be between $183,549 - $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Psychological safety.
We support an environment of fearlessness.
We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
Commitment to diversity.
We strive to foster a welcoming workplace where everyone can thrive.
We're continuously looking to improve the inclusivity of our workforce.
Commitment to community.
We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
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Agios Pharmaceuticals may also be known as or be related to AGIOS PHARMACEUTICALS INC, AGIOS PHARMACEUTICALS INC., Agios Pharmaceuticals, Agios Pharmaceuticals Inc and Agios Pharmaceuticals, Inc.