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Medical writer jobs in Puerto Rico

- 5 jobs
  • Senior Manager, Medical Writing

    Edwards Lifesciences 4.6company rating

    Medical writer job in San Juan, PR

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. **How you'll make an impact:** + Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department + Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties + Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle + Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams + Review and interpret study data analyses + Contribute to the generation of product life cycle plans (e.g., post-market surveillance). **What you'll need (Required):** + Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria + Demonstrated track record in people management or equivalent work experience based on Edwards criteria **What else we look for (Preferred):** + Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria + Medical writing or regulatory certification or equivalent work experience based on Edwards criteria + Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria + Experience working in a regulated industry or equivalent work experience based on Edwards criteria + Certification in related fields + Strong leadership in project and team management, including coaching and performance oversight. + Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. + Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. + Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). + Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. + Familiarity with coronary interventional and structural heart environments. + Proven ability to develop metrics demonstrating medical writing value to the business. + Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $142k-201k yearly 3d ago
  • Field Director, Medical Science Liaison (Immunology/Neurology)

    Grifols 4.2company rating

    Medical writer job in Puerto Rico

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The primary responsibility of the MSL Field Director is the management, performance, and coaching of a team of MSL direct reports in the Immunology and Neurology therapeutic area (MSL primary call points include Immunology, Neurology, Hematology/Oncology). The Field Director ensures compliant execution of field medical plans, strategy, and activities within Medical Affairs, as aligned with goals and objectives. This position is a remote full-time role in the US with estimated 50% travel. Primary responsibilities include but are not limited to: Ultimate responsibility for scientific knowledge of self/team and oversight of a team of MSLs throughout the entire US. Maintains clinical knowledge of designated therapeutic area(s) and broad market knowledge. Provides leadership and serves as primary point of contact for operational/executional requests and solutions for the therapeutic area(s). Partners with the Medical Directors, National MSL Sr Director, and North America Medical Affairs Sr Director to develop field medical strategies and tactics Responsible for the MSL team's execution of field medical strategy for the assigned therapeutic area(s) Conducts and/or assists MSLs in conducting formal presentations to appropriate groups such as the following: key accounts, managed care organizations, integrated systems, national medical associations, and medical schools. Acts as an “ambassador” representing Grifols' position and interests. Participates and contributes in cross-functional teams (e.g., sales, marketing, global medical affairs) regarding field-based activities, medical insights, competitor activity gathering, data analysis, and evaluation of new and innovative initiatives. Involved in the hiring, training, performance coaching, and overseeing the work of a team of MSL direct reports. Maintains the highest level of proficiency in the MSL function Works with other MSL Field Directors regarding standardization and consistency of MSL role. Identifies opportunities for cross-functional integration of MSL roles and activities at the field level. Ensures team's work performance and deliverables meet or exceed goals and objectives. Ensures compliance with all applicable regulatory, legal, and operational rules and procedures of their team. Skills/Qualifications/Education: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions) Previous leadership experience managing a team of MSLs (e.g., MSL Field Director, Regional MSL Director, National MSL Director, or equivalent) and proven history of success required. Strong science/clinical background with advanced degree in a scientific field of study (PharmD, MD, PhD, or advanced/Master's nursing degree) Typically requires 4 or more years of pharmaceutical industry experience as a field-based medical science liaison. Experience developing and executing Key Opinion Leader territory plans, medical plans, and other field medical strategies. Multi-dimensional in abilities to work on simultaneous tasks and work cross-functionally at various levels of the organization. Strong organizational and collaborative skills, good personal initiative, attention to detail, and time management skills. Self-directed, intrinsically motivated, flexible in changes in the organization and able to excel with minimal direction in a dynamic environment. Excellent ability to understand, interpret, and communicate complex scientific and medical information and data. Ability to comfortably converse with key academic opinion leaders regarding highly technical information. Ability to manage a demanding travel schedule and be flexible. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate's degree with 6 years of experience, or a master's degree with 2 years of experience. Must possess a valid driver's license in the state in which the employee works and meet the Qualifying Driver Criteria of the Grifols Fleet Program which includes but is not limited to a 5 year Motor Vehicle Records (MVR) lookback of major driving violations. Pay Scale: The estimated pay scale for the Field Director, Medical Science Liaisons , Immunology/Neurology role based in the United States (non-California), is $195,000.00 - $250,000.00 per year. Additionally, the position is eligible to participate in 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, 9 paid Holidays per year, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! For Washington State: Currently, the first year PTO accrual for this role is 160 hours per year. Then, after completion of 365 days of employment the PTO accrual for this role will increase to 180 hours per year. For California: The estimated pay scale for the Field Director, Medical Science Liaisons , Immunology/Neurology role based in California, is $205,000.00- $250,000.00 per year. Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. #LI-CB1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. 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    $34k-62k yearly est. 60d+ ago
  • Business Writer

    Luma Pr

    Medical writer job in Puerto Rico

    LUMA - Built for Puerto Rico We rely on electricity every day. We need it to run our appliances, power the streetlights and produce the goods and services that drive our economy. At LUMA we are committed to provide Puerto Rico with electricity that we all can depend on. At LUMA, we put people first - our employees, our customers and the communities where we live and work. We encourage and inspire our people to embrace opportunities as they work to build an electricity system that will make Puerto Rico a better place. If you're looking for a career where you can make a tangible difference in the lives of your neighbors and your community, LUMA is the place for you. LUMA offers new jobs designed to respond to the current and future needs of the T&D system. Together we're transforming the island's electric transmission and distribution system, and energizing Puerto Rico. Please note that these new jobs with LUMA offer different terms and conditions of employment to those currently in place with PREPA. We will schedule interviews with all qualified PREPA candidates. All PREPA applicants will receive priority in hiring and a compensation package equal to or better than what they receive today. In order to receive notifications as additional positions and locations are posted, please create a profile on our career site. About the Position This position is within the Regulatory Team. The Regulatory Team works to align LUMA's business plan with the public energy policy goals of Puerto Rico and plays a key role for the design, implementation and reporting on key policy initiatives. Regulatory works with all LUMA departments in support LUMA's compliance and reporting obligations under the Operations and Management Agreement, the energy regulator and other governmental bodies. The team works with multiple external stakeholders and is responsible for the delivery of professional written documents, and verbal reason to support compliance and reporting. The Business Writer performs highly complex communications work that requires specialized skills, considerable work experience and a detailed understanding of company knowledge and practices. This position provides editorial, technical, research and analytical support to multiple departments and work groups, with widespread and long-term impacts across the organization. The nature of work requires advanced skills in language, communications, research, and a variety of software applications, as well as the ability to quickly learn new skills as required. Responsibilities frequently lie outside of standard or routine policies, processes and procedures. As this position frequently deals with sensitive or proprietary information, discretion and confidentiality are essential. What will you get up to everyday? Design, create and maintain forms and document templates that are easy to use and easy to read, for use by various departments across the company. Prepare technical, financial, regulatory and business documentation for both internal and external stakeholders, and other written deliverables as required. Review (and correct as needed) the writing of other personnel, including other clerical staff. Prepare training guides, presentations, general communications and correspondence for regulatory bodies, customers, contractors and other stakeholders as needed. Preserve the strictest level of confidentiality when accessing sensitive and/or strategic information. Conduct research using a variety of primary sources, including technical, financial and legal data. Interview subject-matter experts (SMEs) Maintain miliarity with the content, context and organization of major regulatory proceedings' evidentiary records for the purposes of research, citation and cross-referencing. Apply the principles of information design to present complex data in clear, accessible formats. Analyze audience, subject matter and stakeholder requirements to determine the appropriate form, structure, content and presentation of deliverables. Assist in determining stakeholder requirements and developing execution strategies for deliverables and ensure that SMEs provide all necessary content. Analyze complex processes and technical information and distill into clear, concise and consistent documentation. Integrate the results of research and SME interviews into new and existing documents and processes. Investigate, analyze and identify opportunities to address, improve or resolve issues, and provide recommendations as necessary. Serve as a SME on writing, templates, processes and software, and respond to specialized and complex inquiries as required. Provide research, editorial, document design and document control support to executives, workgroups and project teams as required. Proofread and copyedit drafts prepared by other personnel for clarity, concision, consistency, correctness and conformity with applicable style guide(s). Ensure consistency of structure, formatting and writing style across large sets of documents, e.g., regulatory applications. Act as a resource for difficult and complex inquiries and either resolve if possible or liaise with other departments as necessary to obtain a resolution. Prepare and maintain style guides and train other personnel on their usage. Develop and implement training guides for templates, processes, procedures, etc. Train project teams on how to use and write for Management Systems. Provide training to other writers and clerical staff as needed. Follows all policies and procedures. Other duties as assigned. Perform major storm restoration work and associated drills as assigned. Leadership Responsibilities N/A What We are Hoping You Bring to LUMA LUMA's culture is rooted in the concept of People First, Safety Always. We want your knowledge and expertise to pair with LUMA's globally recognized experts in numerous fields such as customer service, field workforce development, high-voltage transmission engineering, distributed energy resources and mini/micro grid integration. Our employees receive substantial training and development, as well as opportunities for advancement and success. Within our People First, Safety Always culture, we're committed to offering continuous learning opportunities and career-long support for our employees. Education Required: College Degree in Journalism, Spanish, English, Communications, or related field. Preferred: Bachelor's Degree in Journalism, Spanish, English or Communications. Experience Required: One year or more of experience as a business or technical writer. Advanced skills in research and analysis, language and written and oral communication. Advanced proficiency with Microsoft Office applications (especially Word and Excel), Microsoft SharePoint and Adobe Acrobat Pro. Experience with Microsoft Visio and Adobe Photoshop, Illustrator and InDesign. Proven ability to meet aggressive deadlines in a fast-paced, high-volume environment. Proven ability to work both collaboratively and with minimal supervision. Demonstrated ability to quickly grasp technical concepts and write clear explanations for a variety of audiences. Fully bilingual, English and Spanish, oral and written. Preferred: 1+ years of experience as a business writer in Corporate Communications or a regulatory environment. Licenses/Certifications N/A Travel Requirements Travel: No Percentage of time: N/A Requires overnight: No Physical Demands Stationary Position - Seldom Pushing/Pulling/Reaching - Seldom Climb - Seldom Kneel - Seldom Grab - Seldom Bend - Seldom Lift/carry over - 5-10 LBS Vision - 20/20 Corrected Vision Hearing - Receive detailed information if spoken to Working Conditions Wet or Humid - Seldom Working near or on moving mechanical parts - N/A Working near or on heavy machinery - N/A Working in high places - N/A Exposed to fumes or airborne particles - N/A Exposed to toxic or caustic chemicals - N/A Frequency of working in outdoor weather conditions - N/A Work with Electricity - N/A Work with explosives - N/A Work on or near a source of radiation - N/A Loud noise conditions (above 87dB)- N/A Other Environmental Factors including weather conditions______________________ We are looking forward to seeing your application! You made it to the end of the job posting! Thank you for expressing interest in LUMA and taking the time to read all the details of this position. We encourage you to apply and give us the opportunity to get to know you better through the recruitment process. Together, we're energizing the people of Puerto Rico. Note: this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, working conditions, physical demands, and activities may change or new ones may be assigned at any time with or without notice. LUMA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $51k-75k yearly est. Auto-Apply 60d+ ago
  • Senior Medical Science Liaison

    Cardinal Health 4.4company rating

    Medical writer job in San Juan, PR

    **About Nuclear & Precision Health Solutions:** The Nuclear & Precision Health Solutions (NPHS) division is committed to improving the lives of patients by applying more than 40 years of experience and expertise in nuclear medicine and precision health. The business provides radiopharmaceutical development, manufacturing, preparation, market access, and business solutions across the care delivery continuum from origin to patient administration. As the only national source for both SPECT and PET radiopharmaceuticals with the largest network of 130 pharmacies and 30 cyclotron facilities, we can reach 95% of U.S. hospitals within three hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, so they can focus on their patients. **What a Senior Medical Science Liaison contributes to Cardinal Health** : The Senior Medical Science Liaison acts as a representative of the Nuclear & Precision Health Solutions (NPHS) medical affairs department to support Cardinal Health customers, the scientific development of radiopharmaceutical drug products, and medical education. This role leverages internal product knowledge and medical and clinical subject matter expertise to develop activities that deliver highly credible, and fair/balanced scientific information to internal and external stakeholders. The individual will establish professional relationships with medical thought leaders including key opinion leaders (KOLs) to communicate and understand key relevant clinical and research insights and develop and deploy scientific and clinical education for healthcare professionals, patients and others. This role joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions and within a region to maximize theranostic knowledge and clinical strategies + Lead scientific strategy at medical congresses + Lead internal and external clinical education programs + Provide timely feedback/information on emerging clinical/scientific data and opportunities from literature and market insights to internal teams and stakeholders (strategy, business development, marketing) + Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider settings in both groups and one-on-one situations + Identify Key Opinion Leaders (KOLs) to establish and maintain scientific relationships; connect with KOLs in academic and community centers in multiple therapeutic areas focused on radiopharmaceuticals (oncology, neurology, cardiology) + Act as a technical resource to physicians, nuclear medicine technologists, and other healthcare providers using NPHS products + Act as primary liaison to investigators interested in developing and performing investigator-initiated research of NPHS products + Collaborate with NPHS Clinical Affairs to enhance patient enrollment in NPHS-sponsored clinical trials with site recommendations and maintain contact with investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including any MSL presentations and Medical/Safety Review Committees + Provides pharmacovigilance support through collaboration with other internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying customer needs or knowledge gaps to ensure customers use our products safely and effectively + Participate in internal advisory boards to support product safety monitoring and medical affairs oversight **Qualifications:** + 10+ years of experience as a Medical Science Liaison or in a similar clinical education role with customer facing experience + Radiopharmaceutical hands-on experience is required, i.e. Nuclear Medicine Technologist experience + Nuclear Medicine certification (NMT, CNMT) or MD/DO/PharmD/RN/PhD preferred + Bachelor's degree in a scientific field and/or medical discipline in applicable field highly preferred + Current working knowledge of US legal, regulatory, and compliance regulations & guidelines to industry interactions with healthcare professionals + Possess the ability to partner and maintain relationships within the medical community + Proven ability to work independently and in cross-functional teams and networks + Outstanding written and verbal presentation skills + Proficient knowledge of Microsoft Office + Strong business acumen, project management, analytical, communication and decision-making skills + Ability to thrive in a matrix organization and enjoy a problem-solving, fast-paced environment + Strong customer facing experience with ability to interact with all levels of internal and external customers + Ability to travel up to 20% when needed (primarily to scientific conferences, customer locations); can work remotely from home when not traveling **What is expected of you and others at this level:** + Interacts with subordinates, peers, customers, and suppliers at various management levels + Interact with senior management + Independently lead Medical Affairs projects + Utilizes broad and deep knowledge to develop innovative new business practices, policies and procedures + Contributes to the development of department strategy + Works on or lead highly complex projects of large scope + Provides solutions which set precedent + Consults with management to determine project objectives with long-term implications + Acts as a mentor to less experienced colleagues **Anticipated salary range:** $105,600-$167,265 **Bonus eligible:** Yes **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 11/15/2025 *if interested in opportunity, please submit application as soon as possible. _The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity._ _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************
    $105.6k-167.3k yearly 45d ago
  • Scientific Writer

    Ladgov Corporation

    Medical writer job in San Juan, PR

    Scientific Writer Location: USDA Forest Service, International Institute of Tropical Forestry (IITF), San Juan, Puerto Rico Schedule: Monthly: Develop scientific briefings, blogs, research highlights, and outreach products. Quarterly: Submit written progress reports. Bimonthly: Deliver reports for the Forest Service American Relief Act 60-day Congressional Report. Annually: Provide text for an IITF Accomplishment Report. Key Responsibilities Translate technical and scientific findings into clear reports, articles, and outreach products. Develop communication materials related to hurricane recovery and forest resilience science. Provide writing support for briefings to USDA leadership, Congress, and the public. Collaborate with IITF scientists and communication staff to consolidate evidence, photos, and project materials. Advise on communication strategies for science delivery and branding. Attend regular meetings to review deliverables and progress. Qualifications Master's degree in communications, science writing, or related field. At least 5 years of experience in scientific writing, public affairs, or communications. Bilingual proficiency in English and Spanish. Experience in public relations, outreach campaigns, and science branding. Strong teamwork and collaboration skills in a research environment.
    $54k-85k yearly est. Auto-Apply 60d+ ago

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