Director, Medical Communications - Rare Disease
Otsuka America Pharmaceutical Inc.
Columbus, OH
The Director, Medical Communications directs Leads and manages the execution of the global and US scientific communication for the global and US scientific communication strategy for the assigned Rare Disease therapeutic area and product portfolio. This includes directing the development and dissemination of core scientific and medical content within the Rare Disease portfolio (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Rare Disease Medical Affairs strategy. The role is a key leadership position within the Rare Disease Business Unit (BU) Medical Affairs team, engaging a small team of internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Senior Director, Rare Disease Business Unit Lead. **** **Key Responsibilities:** **Global Scientific Communication Strategy** + Lead and oversee the execution of a comprehensive medical communications strategy and tactical plan for the Rare Disease portfolio aligned to the overall medical strategy (developed by the medical strategy team) + Collaborate with the Rare Disease Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment + Contribute to shaping the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements + Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models **Content Development Oversight** + Provide oversight for and ensure the strategic alignment of all Rare Disease medical affairs communication materials, including but not limited to + Scientific Communications Platform (SCP) + Global Publications Strategy + Global Medical Publications Plan + Core Disease State Deck + Core Field Materials + Medical Publications + Integrated Medical Communications Planning + New Data Reporting + Medical Information Content Generation **Publications Strategy** + Direct strategic vision and ensure execution of the global publication plan for Rare Disease assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals + Direct agency and vendor relationships to deliver high-quality publication deliverables **Congress Planning** + Set priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs) + Ensure coordination of scientific communication objectives and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles **Cross-Functional Leadership** + Act as a thought leader and advisor on core Rare Disease team meetings, aligning communication plans with Rare Disease BU Medical Strategy and supporting cross-functional decision-making + Partner closely with the US Field Medical Affairs Lead to ensure the global field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy + Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education + Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function + Collaborate effectively with global colleagues by demonstrating cultural awareness, understanding regional regulations, and adapting communication and engagement strategies to foster strong cross-border partnerships + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Rare Disease or a related field + Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry + Minimum of 5 years of progressive experience leading, developing, and managing a team of direct reports within a global communications function + Demonstrated track record of leading and executing global and/or US communication strategies for a marketed or late-stage development product, preferably in Rare Disease therapeutic areas + Proven experience in managing complex budgets, leading large-scale initiatives and managing agency and vendor relationships across global or regional projects + Previous experience overseeing or leading medical information groups is a plus **Skills and Competencies:** + Strong ability to present to executive leadership team + Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level + Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that drive cross-functional alignment and measurable outcomes + Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress) + Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.$183.3k yearly 2d agoAssociate Director/Director, Medical Science Liaison - Oncology, Central Region (Field-based)
Eisai Us
Columbus, OH
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Associate Director/Director, MSLs is responsible for the leadership, direction and management of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies across the product portfolio. Works closely with his/her direct reports in the field, Medical Directors and at times with external customers to gain an understanding of the scientific landscape and to communicate the information to key internal stakeholders. Provides all direct reports with an individualized view of their development plans and ongoing performance. Assists other managers with leadership competency criteria including performance management assessments of their MSLs and recommendations of promotions Creates a culture of accountability by personally delivering on work commitments, holding others accountable for their performance and by taking, timely, decisive and constructive actions to address individual MSL performance problems and issues. Essential Functions * Ensure operational excellence of the MSL team, including corporate aligned objective/tactics, cross-functional medical support, and interactions with key opinion leaders. * Provide leadership for the MSL function by participating on cross functional teams leading to strategic planning and working collaboratively with Commercial colleagues including, Sales and Marketing as well as Medical Affairs. * Developing individual talent within the MSL region, including training, career evaluation, coaching, mentoring, performance management and talent review. * Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry, and to ensure compliance with Eisai policies & procedures and standard operating procedures. * Manage MSL activities related to presenting medical and scientific information to external customers, including but not limited to, medical thought leaders, academic institutions and managed care organizations. * Assist with recruiting, interviewing hiring, and on-boarding new MSLs. * Travel (up to approx. 50%), locally across the US when required and including international travel. Requirements * Advanced scientific terminal degree (MD, PhD, PharmD) * Must have a minimum of 5 years of experience within the pharmaceutical industry overseeing a Medical Science Liaison team or related function. * Excellent interpersonal, communication, and management skills required. * Strong personal integrity and customer focus are necessary. * Ability to work at a distance to maintain morale of field based personnel, as well as good interaction with office based Medical Affairs and PCU scientific staff. * Must possess a thorough understanding of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory/ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these external as well as internal Eisai guidelines and standard operating procedures. * Must be able to organize, prioritize, and work effectively in a constantly changing environment. * Ability to interface effectively with a variety of technical platforms for recording of external interactions and for the collection, review, and dissemination of medical information. As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, People Development, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the Associate Director/Director, Medical Science Liaison - Oncology, Central Region (Field-based) is from :$198,900-$261,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation$198.9k-261k yearly Auto-Apply 60d+ agoClinical Quality Assurance Specialist
Lumos Pharma
Remote job
Clinical Quality Assurance Specialist Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs. This position reports to the Vice President, Quality and Compliance, and is responsible for providing quality oversight of clinical trial activities performed in compliance with Good Clinical Practices (GCP). This position also supports internal quality systems and compliance functions. The Clinical Quality Assurance Specialist is expected to execute established processes involving quality assurance, quality systems, and compliance. ESSENTIAL FUNCTIONS Author, review, and/or approve SOPs, protocols, study plans, and other applicable clinical documents in accordance with GCP requirements Provide input on protocol deviations and associated corrective/preventive actions involving clinical trials. Perform audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.) Complete required tasks in the electronic quality management system Assist with training coordination, ensuring employees are up to date on quality and compliance requirements Assist with audits of external suppliers Routinely work with internal and external stakeholders to achieve cross-functional goals. Each employee is responsible for financial and compliance controls as they relate to their roles. For example, being fiscally responsible in purchasing decisions and completing compliance training within the specified time frames. REQUIRED QUALIFICATIONS Education Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, Chemistry, Health Administration, or related technical discipline EXPERIENCE 1-3 years of experience in quality assurance within the pharmaceutical or biotech industry PREFERRED QUALIFICATIONS Knowledge of GMP and GCP regulations Strong attention to detail, documentation accuracy, and organizational skills Microsoft Office Experience with MasterControl is desirable Experience with CDER BIMO inspections is desirable COMPETENCIES Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization. Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to technical and non-technical audiences. Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders. Business Acumen: Business acumen is the ability to understand and discriminate between various business-related topics and issues. Decision-Making/Judgment : Decision-making skills look at the ability of the individual to select an effective course of action while controlling resources and expenditures. WORK ENVIRONMENT This position can work remotely in the United States. TRAVEL EXPECTATION Up to 10% What you can expect as a Lumosian Industry-competitive compensation Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance. Lumos covers 85 - 95% of the medical premium Health Reimbursement Arrangement 8 weeks of fully paid parental leave for all new parents Gym or fitness class reimbursement 401(k) with 5% employer contribution Flexible work hours and location Generous PTO policy 11 paid holidays in the US Offices in Austin, TX, and Ames, IA$51k-86k yearly est. 34d agoAccount Management Director
Eclinical Solutions
Remote job
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. You will make an impact: As a Account Management Director, you will ensure eClinical Solutions customers achieve their desired business outcomes, by utilizing the elluminate software platform. We are looking for technically savvy individuals that possess the drive to build relationships and demonstrate value through results. The goal of the Account Management Director is to increase customer satisfaction, loyalty, and retention to meet and exceed their expectations. Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. Your day to day: Develop trusted advisor relationships with customers and manage the customer lifecycle, from initial contract through renewal Collaborate with client leadership to translate their strategic direction into a series of actionable and measurable outcomes Deliver customers a data strategy that leverages elluminate and eCS professional services Analyze and resolve customer requests, complaints, and feedback with internal teams to improve client experience Maintain documentation in the eCS Customer Success system. Including a record of customer communication, milestones, and business reviews Create and share educational resources, trainings, and best practices, to include product demonstrations and explanation of product roadmap Contribute to revenue generation through renewals, upsells, and expansions Drive growth and profitability by adding value by encouraging deeper feature adoption Collaborate cross-functionally within eCS to promote customer success, specifically with Product and Engineering to understand and evaluate customer feature requests Take the first step towards your dream career. Here is what we are looking for in this role. Qualifications: Bachelor's degree in sciences, business, computer science, communications, or related field preferred Clinical Data Management and/or clinical programming experience preferred Experience in clinical research or drug development industry is preferred, including knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, Clinical Data Management, SDLC in regulated environments, and industry standards preferred 3+ years of experience successfully implementing SaaS and/or enterprise software applications. Clinical research and/or life sciences a plus 2+ years cross functional program/project experience, with a demonstrated track record of execution bringing product from concept through market release is required Self-motivated to prioritize and manage Knowledge of pharma and life sciences Excellent verbal and written communication Demonstrated leadership ability to work effectively at all organizational levels Self-driven learner with the ability to build proficiency in new topics quickly. Specifically, the pharmaceutical industry and clinical trials process Exceptional communication and written skills and the ability to create documentation and multi-task Knowledge of customer success processes Enterprise software and service delivery Must be an avid problem solver with proven ability to make timely decisions while dealing with ambiguity Must be a team player who thrives on working collaboratively and skilled at influencing Is achievement oriented, i.e.: measures performance, improves outcomes, sets challenging goals Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: ****************************************************** eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. Pay Range US Pay Ranges $92,000-$138,000 USD$92k-138k yearly Auto-Apply 1d agoPharmacy Technician (PRN)
Evolution Research Group
Columbus, OH
About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I-IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. : This role prepares, compounds, manufactures, and dispenses investigational drugs and materials issued by the company for ongoing research studies. The candidate will be responsible for the coordination, organization, and efficient implementation of clinical data as it relates to the conduct of site's IP Pharmacy and completes all duties under the direction of the Site Manager or designee. In this role you will maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Research Pharmacist is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies. We value the spirit of collaboration in our teams and believe that to be successful, we must be a patient-centric organization. The successful candidate will be certified as a Pharmacy Technician or be an LPN with clinical research pharmacy experience. Must be knowledgeable in medical terminology and be well organized and methodical in approach. Responsibilities: Follow step-by-step procedures and/or kits for preparation, dispensing and distribution of investigational and study drug. Use codes, labels, and other predefined formats for pharmacy computer entry. Establish and maintain adequate and easily retrievable recordkeeping systems for protocols, study subjects, drug inventory and dispensing investigational drugs per regulatory requirements and ICH guidance requirements for handling investigational products Use drug data sheets and other documents Maintain standards which assure quality, proper storage and safe use of all investigational agents and related supplies. Perform ordering and stocking of investigational and study agents. Perform the removal and disposal of expired stock or stock from completed or terminated studies according to protocol guidelines. Complete and retain paperwork. Handle investigational and study drugs according to the requirements of the sponsoring agencies. Prepare special formulations of investigational agents under unusual circumstances as dictated by a particular protocol. Assist with appropriate monthly pharmacy audits to ensure that company policies and procedures are met. Assist in quality assurance procedures as needed. Maintain a neat and clean work area. Develop a well-organized work routine. Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives. Skills and Qualifications: Education and experience Training and/ or certification as a Pharmacy Technician Prior hospital pharmacy experience is strongly preferred. Knowledgeable in medical terminology Requirements Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods. Excellent verbal and written communication skills$27k-37k yearly est. 3d agoDirector, Drug Safety & Pharmacovigilance
Bridgebio
Remote job
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do Director of Drug Safety will be responsible for managing all aspects of the drug safety functions related to US and assigned postmarketing data review and reporting. Manage the drug safety contract service organizations (CSOs) for postmarket pharmacovigilance with >=95% compliance with periodic reporting, signal management, and global risk management plans and, manage on-time and scientifically sound local safety report preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators Develop and prepare assessments of global safety data, signal management, and benefits/risks for internal senior management as well as external partner or regulatory authorities Accountable for global periodic safety review and signal management meetings, and relationships with all internal and external stakeholders, and maintain audit trail as inspection ready at all times Responsibilities Accountable for maintenance and inspection readiness of the quality management system for signal management (GVP Module IX.B.5) and PBRER preparation Leads data collection for signal examination and assessment within timelines Accountable for ad hoc safety review meetings, including all internal and external stakeholders, with 100% compliance with signal evaluation timelines, and maintain audit trail as inspection ready at all times Manages the authoring of aggregate reports including PBRER, and other local safety reports as required Manages the authoring and collaboration with partner for global risk management plans Manages the PV agreements and compliance of all assigned local distribution organizations and for compliance tracking for all safety submissions across all drug safety functions of the local distribution organizations, maintain audit trail as inspection ready at all times Oversee the creation of periodic report and signal management reports, analysis, and presentation of safety data from the safety database, and maintain audit trail as inspection ready at all times Manages ongoing reconciliation of incoming safety information and the safety databases Develops and prepares reports for company management as well as external regulatory agencies Ensure compliance with standard operating procedures and clinical trial and post-market global drug safety regulations, including to the FDA, EMA, MHRA, and all assigned international RAs Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects Where You'll Work This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Who You Are Bachelor's degree in a health care discipline or equivalent is required, and an advanced degree is preferred Requires at least ten years of drug safety and pharmacovigilance experience (post-market safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least three years of oversight management experience (line management or CSO management) Experience in post-marketing safety, including clinical development preferred Experience with Regulatory submissions for PSUR, PBRER, RMP, and other countries' Regulatory reviews; experience in US, EU Canada, Brazil, Australia preferred QPPV service management and oversight, PSMF authoring experience Direct FDA and EMA, but also other regulatory bodies (e.g. Anvisa, Health Canada...) inspection experience Growing a clinical trial drug safety system into a global post-marketing PV system Demonstrated ability to successfully manage drug safety team or drug safety CRO for clinical and post-marketing programs with responsibilities for ICSR collection, expedited reporting, on-time PSUR preparation, and meeting corporate goals and key performance indicators Safety signal management, and tracking, including supporting regulatory documentation Experience in drug safety audits and agency inspections as case processing, PSUR, and CSO management subject matter expert Intimate knowledge of GCP and strong working knowledge of FDA or other agencies, Good Clinical Practices, and ICH regulations and guidelines Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities #LI-NT1 At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$220,000-$320,000 USD$65k-110k yearly est. Auto-Apply 5d agoDirector of Operations
Syneos Health Clinical Lab
Remote job
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities The Director of RWLP Operations is a strategic, client-facing leader responsible for driving operational excellence across real-world and late-phase research portfolios. This role ensures successful delivery of peri- and post-approval studies while fostering account growth and long-term client partnerships. Acting as a subject matter expert and operational strategist, the Director provides end-to-end oversight-from RFP/proposal development to portfolio execution-ensuring integrated, cost-effective solutions aligned with client objectives. Key responsibilities include: Leading cross-functional teams to deliver complex, global RWLP programs on time and within budget Overseeing all aspects of assigned client accounts, including governance, risk management, financial performance, and strategic planning Partnering with internal and external stakeholders to identify evidentiary needs and deliver tailored operational solutions Ensuring alignment of delivery with regulatory standards (ICH, GCP, GPP) and Syneos Health SOPs Supporting business development through proposal strategy, bid defenses, and capability presentations Driving operational efficiency, quality, and innovation through lessons learned, process improvement, and cross-BU collaboration This role requires strong real-world research acumen, proven operational leadership, and a commercial mindset. Ideal candidates will bring: 10-12 years of clinical research experience, with 8-10 years in RWLP Direct experience with large-scale RWLP programs and client portfolio oversight Strong financial and contract management skills Prior CRO/pharma experience in cross-functional, global environments Excellent communication, team leadership, and stakeholder management capabilities The Director may have direct reports and is expected to travel up to 25% of the time. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.$81k-132k yearly est. Auto-Apply 8d agoClinical Biomarker Specimen Specialist - FSP
Parexel International
Remote job
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager, Study Managers, and Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody is maintained through the specimen lifecycle from collection through testing and final sample disposition. This role requires clinical study, specimen management, and project management experience. As well as knowledge of GxP and vendor-sponsor best practices. Key Accountabilities: Oversight of programming activities: Clinical specimen management from collection through testing and final disposition Ensures compliance with clinical protocol and informed consent. Maintain chain of custody for specimens Organize and oversee the collection, shipping and proper storage and maintenance of clinical specimens Resolve and/or triage specimen queries from sites or vendors Ensuring proper documentation of specimen destructions are obtained and filed appropriately Collaborative relationships: Collaborate on implementation and maintenance of specimen tracking system Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study-level execution of specimen management Compliance with Parexel standards: Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Effective project management and time management skills; able to prioritize successfully Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession Detail oriented; performs quality and accurate work with minimal oversight Excellent written/verbal communication skills Can identify opportunities for efficiency improvements and simplification, recognizes appropriate. Resources for deliverables, has effective organizational skills Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively Flexible, easily adapts to change, and is energized by challenges and problem-solving Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate Other competencies include managing complexity and ambiguity, decision quality, collaborates, cultivates innovation, customer focus, nimble learning, balances stakeholders, and action oriented Proficiency in written and spoken English - required Proficiency in local languages (as applicable) Knowledge and Experience: Years of experience: 2-5 years; dependent on level of related skills and education Laboratory background and/or strong knowledge of commonly tested biomarkers in the Oncology setting, latest and advanced analytical tools and assays Proficiency with data sets and Excel, understanding of data relationships and metadata Confident in overseeing vendors and communicating with experts to drive quality deliverables Preferred: Previous biobanking, sample tracking and handling experience Previous LIMS (Laboratory Information Management System) experience Working knowledge of the clinical drug development process Working knowledge of the Food & Drug Administration (FDA) regulations, International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines, Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), database development and User Acceptance Testing (UAT). Oncology experience and/or working knowledge Proficiency with timeline management Education: Bachelor of Arts/Bachelor of Science in relevant field, or other relevant experience/qualification EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.$64k-108k yearly est. Auto-Apply 4d agoSoftware Engineer
Character Bio
Remote job
Character Biosciences Character Biosciences is a drug discovery and development company building world-class, deeply-phenotyped databases that integrate genomics with longitudinal clinical and imaging data in age-related macular degeneration (AMD) and glaucoma therapeutic areas. Our interdisciplinary team, comprising experts in clinical science, data science, statistical genetics, machine learning and drug discovery utilize these platforms to determine genetic drivers of disease progression, advance novel therapeutics and define genetics-based patient stratification. Character is currently advancing two programs in AMD towards clinical development with additional programs in earlier stages of discovery research in AMD and glaucoma areas. The Opportunity We are looking for an experienced software engineer to join our team and contribute to the build out of our observational study software and broader data platform. As a member of a small team, you will play an active role in product design and development via partnership with internal end-users at Character Bio. You will play a key role delivering technology solutions that will enable a wide range of functions across the company, including clinical trial operations, data science, and genomics. This role requires a collaborative working style, attentive listening and an ability to translate the expressed needs of non-technical staff, as well as leadership to propose creative solutions that balance tradeoffs. The multi-modality information content within our data can be complex, so candidates should also be literate and interested in longitudinal clinical data, as well as medical image and genomic data, from a scientific and regulatory perspective. This is a fully remote role. Key Responsibilities Collaborate with our clinical research team to develop features that support our longitudinal studies Build appropriate tooling to connect deidentified and processed data with our data science environment Integrate third party software platforms to ingest and transform patient data, and extend these platforms by building and configuring data exploration and analysis apps Skills and Qualifications Bachelor's Degree and 3-5 years of experience building and deploying web applications (familiarity with Django highly preferred) Some familiarity with frontend development (this is not a frontend-heavy role, although there are times when frontend knowledge will be a critical requirement for development). Experience with cloud platforms, CI, and containerized deployments, particularly GCP and Kubernetes Demonstrated ability to communicate technical concepts, gather requirements from, and provide technical guidance to non-technical stakeholders Track record of self-directed work and proactive problem-solving Ability to express a strong product sensibility with user-centered design, and anticipate user needs Comfortable with scoping, designing, and implementing features with minimal technical oversight Preferred Qualifications Experience working with sensitive or regulated data Previous experience in healthcare or clinical research Familiarity with compliance frameworks (HIPAA, 21 CFR Part 11) Compensation & Benefits The annual pay range for this full-time position is $140-180k base + bonus + equity + benefits. The stated compensation range reflects pay for roles based in New York or San Francisco metro area; compensation for hires in other locations may be adjusted based on the local market rate. Benefits include a competitive salary, bonus, strong equity incentives, medical, dental, vision, 401(k), and an accrued paid time off policy. Character is committed to recruiting, developing, and supporting colleagues from all backgrounds. We embrace diversity, equity, and inclusion as an integral part of our culture.$140k-180k yearly Auto-Apply 47d agoVice President / Senior Vice President, Global Regulatory Affairs
Vistagen
Remote job
The Vice President/Senior Vice President, Global Regulatory Affairs will lead our regulatory strategy, ensuring compliance with global regulations. This team member will lead strategy, preparation and submission of regulatory documents, including NDA, IND, and other submissions. Working with the cross-functional development team, they will lead all Health Authority meetings associated with the program, hold accountability for the program's global regulatory plan and its execution, identify and assess regulatory risks associated with planned clinical development activities and provide technical advice and counsel. This is a critical leadership role within the company and has a significant influence on the achievement of corporate and program objectives and key results. This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Chief Operating Officer. Key Duties & Responsibilities: Key responsibilities of this role include, but are not limited to: * Lead the global regulatory strategy for the assigned product(s), accountability for ensuring that plans meet global regulatory requirements. * Work cross-functionally with other internal departments and external partners to develop, strategize, and submit regulatory documents (NDA, IND, etc.). * Lead Health Authority meeting planning, preparation, and conduct; accountable for the delivery of optimal meeting outcomes. * Proactively identify and assess regulatory risks associated with planned clinical development activities. * Review and approve all submission documents, including clinical study protocols and reports, statistical analysis plans, investigator brochures, development safety update reports, and other documents as needed. * Support strategy for providing submission of CMC and non-clinical information. * Act as the independent subject matter expert in giving guidance to project teams, departments, and management; provide strategic counsel to C-Suite executives. * Contribute to the development of target product profile and draft labeling. * Stay current with evolving regulatory requirements and industry trends, interacting with regulatory agencies and ensuring the company's compliance with global regulations. * Provide training and education on regulatory topics to internal stakeholders. * Recruit, mentor, and develop a high-performing regulatory team, fostering a collaborative and innovative work environment. * Serve as the primary point of contact with the FDA and other health authorities, as applicable. Qualifications: * Advanced degree in science (Ph.D., MD, PharmD) in a relevant scientific discipline. * 15+ years of industry experience with a minimum of 10+ years of progressive leadership experience in regulatory affairs within the biotechnology or pharmaceutical industry. * Proven experience with various Phase I-III and NDA submissions with a preference for recent, successful approval. * Broad regulatory background with ability to act as both a generalist and specialist depending on what's needed. * Significant experience with US FDA regulations; strong understanding of Global Health Authority policies, laws, regulations, and guidelines as they apply to drug development and approvals. * Significant knowledge of the drug development process (early-stage through commercialization). * Exceptional leadership, communication, negotiation, and stakeholder engagement skills. * Demonstrated ability to prepare for launch readiness. * Ability to travel up to 15-20% (US and international). Compensation and Benefits What we offer: * Industry competitive compensation * Performance-based bonuses * Stock options * Employee Stock Purchase Plan * 401k plan * A collaborative and innovative work environment at the forefront of biotech advancements Give your best, live wholesomely: * Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents * FSA and HAS * Basic Life Insurance 2x Earnings and AD&D * Employee Assistance Program * Healthcare advocates group to help navigate the healthcare system Work-life balance: * Unlimited paid time off * Flexible work schedule * Remote work option * Paid holidays * Mental health days * Winter shutdown * Casual work environment We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence. The anticipated salary range for candidates who will work remotely is $300,000-$400,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc. Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents. Physical Demands: The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often. Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. This position requires the ability to lift and/or move up to 25 pounds occasionally. Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment. DISCLAIMER The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification. All Employee's have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA) OVERVIEW OF THE COMPANY Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen's neuroscience pipeline is designed to rapidly activate olfactory system and rain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen's neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at *****************$300k-400k yearly 12d agoClinical Laboratory Coordinator
Medpace
Remote job
Medpace Clinical Pharmacology, a 96-bed facility specializing in early phase clinical trials, is led by a team of highly trained clinical researchers who are experts in the design, implementation, and analysis of Phase I - IIa studies. The Phase I Unit, functionally integrated with Medpace, a large global Clinical Research Organization, conducts studies and collaborates with the best therapeutic minds in the industry to bring promising drug compounds to the market. Responsibilities * Plan and organize laboratory activities for assigned projects including ensuring adequate procedures are in place for handling, processing, storing and shipping specimens; * Train Research Assistants on appropriate processing techniques required for assigned studies; and * Maintain supplies and make sure those necessary for laboratory functions are available. Qualifications * High School Diploma and 3-5 years of Laboratory Experience * Flexible schedule with the ability to work first and second shift as needed. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Today The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Hybrid work-from-home options (dependent upon position and level) * Competitive PTO packages, starting at 20+ days * Flexible work hours * Discounted tuition for UC online programs * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Competitive compensation and benefits package * Structured career paths with opportunities for professional growth * Partnership and discount with onsite childcare * Discounts on local sports games, local fitness gyms and attractions * Official Sponsor of FC Cincinnati * Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets$52k-70k yearly est. Auto-Apply 36d agoSenior Implementation Consultant
Eclinical Solutions
Remote job
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. You will make an impact: As a Senior Implementation Consultant, you will be responsible for liaising with our clients and internal stakeholders to align our client's clinical data strategy to tools and functionality within elluminate. Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. Your day to day: Participate in elluminate implementations by providing business process and product best practices consulting services to support the technical and project management team members Provide efficient and effective implementation services for clients, by ensuring appropriate requirements gathering through sound assessment of the clients' elluminate environment and expectations Consult in a post-implementation capacity to measure and drive an increase in the ROI customers receive from elluminate Steer productive elluminate implementation workshops through a consultative process, administer training sessions, if necessary, and provide high-quality support Align client clinical data review objectives to functionality in elluminate and delivers gap analysis where applicable Collaborate with Technical, Engineering, Product, and Project Management team members to develop new and enhanced product offerings in alignment with client objectives; drafts specifications and prototypes as needed Configure elluminate software to meet the client requirements Support elluminate training team in preparation of course materials and delivery of courses Assist sales effort to drive new sales by delivering Proof of Concept, Prototypes/Pilots and targeted presentations that fulfill client expectations Collaborate with Marketing to develop client specific case studies and share client success Participate in the development of new processes, best practices, and recommend improvements to all procedures to ensure an optimal level of client satisfaction Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures Other duties as assigned Take the first step towards your dream career. Here is what we are looking for in this role. Qualifications: Bachelor's degree or higher preferred, analytic discipline a plus and/or equivalent work experience 5+ years of experience Pharmaceutical/Biotechnology/CRO Experience in a software development environment a plus Knowledge of the drug development process and clinical trial execution as they relate to data collection, management, analytics, and reporting Understanding database concepts and ability to use data to optimize reporting, data mapping and programming Analytical and technical skills and experience with analytic software applications (i.e., Spotfire, J-Review, Qlik, Tableau) Prior management and delivery of technical projects in a professional services environment is a plus Proficiency with clinical data review and analytics solutions required Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: ****************************************************** eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. Pay Range US Pay Ranges $116,000-$145,000 USD$116k-145k yearly Auto-Apply 23h agoAssoc Director-Imaging Portfolio Project Management
Eli Lilly and Company
Remote job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: This position will support delivery of Lilly Imaging's molecular imaging agents and biomarkers portfolios by leading cross-functional teams to develop and drive robust, integrated project plans continuously optimizing processes through tools and capabilities; and, supporting modernization of the Lilly Imaging infrastructure and business operations reporting Responsibilities: Support Portfolio Delivery through Project Leadership Work with cross-functional teams in Lilly Imaging (Research & Discovery, clinical development, Imaging Operations, Medical, Regulatory) and key business partners such as Tech@Lilly, CMC, Clinical Design & Delivery, Radioligand Therapy (RLT) to develop and deliver project plans that encompasses all project management knowledge areas (timeline, scope, risks, communications; budget where applicable) Hold project teams accountable for achievement of key deliverables in alignment with the project plan and corporate quality standards Develop and implement team communication plans, decisions, risks / issues to stakeholders; maintain documentation and create visualizations and messaging upward and across organization Help manage the organization's various portfolios of work (clinical, non-clinical, data and digital) for different therapeutic areas (Neuroscience, Oncology, Immunology, Diabetes) to identify and communicate integration risks and impacts across projects, and create milestone roadmaps Continuously Improve PM Capabilities, Competencies, and Business Processes Support the expansion of PM capabilities and competencies throughout Lilly Imaging and key business partnerships through applied PM tools and techniques, and shared learning Lead special projects as needed to optimize business processes; expertise in Smartsheet portfolio management and reporting capabilities a plus Support Imaging Infrastructure and Business Reporting Modernization Efforts Partner with peers and functional leaders to identify modernization and optimization opportunities Liaise with Tech@Lilly and Lilly business functions to identify and build implementation plans that leverage needed capabilities and tools Create and implement change management plans to support adoption of new processes and tools Basic Requirements: Bachelor's degree with at least 10 years of project management experience in the radiopharmaceutical or pharmaceutical industry, with a proven track record of leading complex projects within Clinical Development Proficiency with various project management tools (e.g., MS Project, Smartsheet, Jira) and methodologies (e.g., Waterfall, Agile) Proficiency with Microsoft Word, Excel, PowerPoint, Project and working in O365 platform Strong problem-solving skills; able to anticipate and recognize issues and barriers, diagnose root causes, validate/confirm, and propose creative alternatives to influence corrective actions Excellent verbal and written communication skills, with the ability to engage effectively with technical and non-technical audiences, and communicate clearly and concisely with leadership Ability to work in a fast-paced, dynamic environment and adapt to changing priorities. Additional Skills/Preferences: PMP certification / Applied knowledge of project management processes Proficient in self-management and organizational skills; able to manage workload, set personal, team priorities, and adjust as needed Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse styles Technical project / system implementation incorporating change management for business adoption Additional Information: Travel 0- 10%, depending on location - team presence primarily in Philadelphia, PA and Indianapolis, IN offices Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $187,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly$115.5k-187k yearly Auto-Apply 3d agoCustomer Success Manager
Verantos
Remote job
Located in California's Silicon Valley, Verantos is the global leader in high-validity real-world evidence at scale. By applying artificial intelligence to the complete patient record, Verantos enables life sciences organizations to generate high-validity evidence across therapeutic areas with measured accuracy, completeness, and traceability. Credible evidence accelerates clinical development, market access, medical affairs, pharmacovigilance, and regulatory initiatives. Verantos believes that advanced RWE requires a group of dedicated and highly-trained professionals who are specialists in the field. Our team consists of physicians, data scientists, clinical researchers and engineers with a deep knowledge of, and extensive experience in, protocol development, health system engagement, electronic health record integration, de-identification, artificial intelligence, data enrichment, study implementation and validity assessment. In addition, we have vast experience within the healthcare ecosystem, including pharma, payer, provider, and regulatory As a Customer Success Manager within the customer success team, you will be responsible for managing project progress from initiation to on-time delivery and ensuring high-quality deliverables to our life-science customers and healthcare partners. Responsibilities: Manage customer projects from initiation to project closeout Determine stakeholder requirements and develop detailed project plans. Drive the progress, management, performance, and completion of projects. Share project status reports and escalate risks as appropriate to management. Engage with external stakeholders Develop excellent working relationships with customers and research partners. Conduct and lead project meetings including agenda setting, materials preparation, and recording meeting notes and task assignments. Communicate with external stakeholders in a professional manner. Collaborate with key internal stakeholders Work with key internal stakeholders in cross-functional teams. Coordinate with internal teams to answer customer inquiries in a timely manner. Respectfully hold people accountable for their project roles and deliverables. Build mutual trust and encourage cooperation among team members; facilitate consensus building and working across various styles. Qualifications Required Bachelor's degree from a reputed institution Exceptional interpersonal, verbal, and written communication skills At least 2 years of project management experience within the life science, biotechnology, or digital health space Clinical research or real-world evidence generation experience Proficient in project management tools and methodologies Desire to work in a start-up environment with dynamic and diverse teams across multiple time zones Preferred Advanced degree in public health, health administration, or similar field Project management experience within a data vendor Proficiency in tools for data analysis or transformation (e.g., SQL, Excel, Python, or R) AI-first mindset, with a focus on leveraging automation to develop scalable, repeatable solutions for project tracking and risk management Why Verantos? At Verantos, we are pioneering technologies that power advanced real-world evidence (RWE). Advanced RWE helps understand how patient characteristics and behaviors affect health outcomes - helping to predict the progression of a disease, a patient's responses to a therapy, or the risk of adverse events. Come and join a team at the intersection of cutting-edge technology, complex data, and healthcare research. We offer: Flexible work location to support employees in the new pandemic-shaped reality. Medical, dental, vision benefits. 401K plan with employer match. Work-life balance. Opportunity to work with healthcare technology visionaries.$75k-116k yearly est. Auto-Apply 10d agoClinical Modeling & Analytics Solution Lead
Astellas Pharma
Remote job
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** The Clinical Modeling, Analytics & Operational Excellence team is a high-impact innovation team that applies advanced analytics, real-world data, modeling & simulation, and AI/ML to solve critical challenges in clinical development. This team designs and implements predictive models for patient recruitment and retention, optimizes trial feasibility and site selection, assesses novel clinical endpoints, simulates study outcomes to guide protocol design, and develops innovative operational strategies to reduce execution risk and accelerate timelines. The Clinical Modeling & Analytics Solution Lead plays a pivotal role in architecting and developing clinical modeling and analytics platforms, transforming prototypes into production-ready solutions, and enabling self-service tools to meet the evolving needs of efficient clinical operation and optimal trial planning/design. This position will collaborate across the business to design and deliver innovative solutions that improve accessibility, scalability, and reliability of clinical trial insights. **Responsibilities and Accountabilities:** The Clinical Modeling & Analytics Solution Lead: + Architects scalable trial operational data and analytics solutions, ensuring reliability and adaptability to meet long-term analytical needs for clinical trial optimization + Develops user-friendly dashboards and analytics tools and platforms for operational and feasibility insights that support key stakeholders across clinical trial portfolio + Translates data modeling and analytics prototypes into production-ready systems, partners with IT and digital teams to automate data & analytics workflows that are accessible to both technical and non-technical users + Implements processes and pipelines for deploying, monitoring, and maintaining data, analytical, forecasting and simulation models at scale + Collaborates with stakeholders to refine and adapt solutions for operational use + Acts as a key point of contact of Clinical Modeling & Analytics team to collaborate internal technical teams (i.e., clinical data enablement, digital/IT teams etc.), and contributes to the assessment of internal/external solutions + Provides technical leadership and mentorship to junior team members and colleagues involved in clinical modeling data and analytics projects + Develops and implements rigorous data governance practices to maintain compliance, security, and scalability in analytics workflows **Qualifications:** **Required** + Master's or Bachelor's degree in Computer Science, Data Science, Data Engineering, Statistical Programming or related disciplines. + MS with minimum 9+ years of experience or bachelor with minimum 12+ years of experience, preferred in pharma/biotech, CROs or healthcare settings + At least 7+ years of experience in data engineering, modeling, analytics, or solution architecture. + Proven track record in developing data architecture, tools and platforms to support modeling, visualization, and real-time analytics. + Proficiency in programming (i.e., Python, R, SQL etc.), application development (Shiny, Streamlit, etc) and data visualization tools (Tableau, Spotfire, Qlik etc.) + Strong experience with cloud platforms (AWS, Azure, Google Cloud) and related data and analytics systems for deploying and managing data & analytics solutions + Deep knowledge with clinical trial and RWD data standards (CDISC, OMOP, CTMS etc.), EDC systems, and regulatory requirements for clinical trial data + Strong problem-solving abilities and a strategic mindset to tackle challenges in clinical trial data analytics, and able to manage multiple projects and deadlines in a dynamic environment **Preferred:** + Experience in systems and workflows deploying AI/ML applications for clinical trials + Solid understanding of MLOps frameworks and AI/ML techniques (e.g., TensorFlow, PyTorch, Scikit-learn) + Experience enabling GenAI or medical imaging pipelines at the infrastructure level. **Salary Range:** $141,400 - $222,200 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Quantitative Sciences & Evidence Generation Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans$141.4k-222.2k yearly 60d+ agoRegional Director, Medical Science Liaisons (East)
Arcellx
Remote job
Who We Are Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work. What Matters to Us Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team. Arcellx Core Values Start with authenticity: We foster an inclusive environment where each person can bring their authentic self to work. Think ‘we' before ‘me': We prioritize collective success, collaborating and supporting one another to achieve our shared goals. Embrace the challenge: We deliver exceptional results by working with shared determination and a commitment to doing what's right. The “Fine Print” - What You'll Do Leadership & Team Development Recruit, coach, and manage a team of high-performing MSLs, fostering a culture of scientific curiosity, integrity, and collaboration. Develop and execute territory plans in alignment with Medical Affairs strategies, which includes interactions with community thought leaders, disease state experts, cell therapy-referring HCPs, and academic centers. Monitor territory coverage, scientific engagements, and metrics to optimize team impact and resource allocation. Field Strategy & Execution Lead regional implementation of the medical affairs plan, ensuring consistent, high-quality scientific exchange with key community stakeholders in multiple myeloma. Partner effectively with cross-functional departments, such as Clinical Operations, Clinical Development, Marketing, Market Access, Sales, Regulatory Affairs, and Pharmacovigilance and ensure alignment with company priorities. Oversee regional congress planning and ensure effective post-meeting insight dissemination. Maintain deep scientific and clinical knowledge of cell therapy, immuno-oncology, hematology, and multiple myeloma. Skills and Experience We Look For Advanced scientific degree strongly preferred (PharmD, PhD, MD, or equivalent). Master's degree in health sciences (RN, RPh, PA, NP, etc.) considered if extensive years of clinical and/or medical affairs experience in relevant therapeutic area is present. 5+ years of experience in biotech/pharma, including experience in the field and 2+ years of experience in field leadership. Demonstrated expertise in hematology and multiple myeloma; cell therapy or oncology experience strongly preferred. Proven ability to lead and develop distributed teams in a fast-paced, growing organization. Excellent communication, interpersonal, and strategic planning skills. Ability to travel extensively within region and occasionally for national meetings. Successful candidates must live within their region. Rewards at Arcellx Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits. In addition to a competitive base salary, our compensation package includes an annual bonus based on company goals and an equity (RSU) grant. Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more. Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to ****************$75k-169k yearly est. Auto-Apply 42d agoClinical Educator
Imagine Pediatrics
Remote job
Who We Are Imagine Pediatrics is a tech enabled, pediatrician led medical group reimagining care for children with special health care needs. We deliver 24/7 virtual first and in home medical, behavioral, and social care, working alongside families, providers, and health plans to break down barriers to quality care. We do not replace existing care teams; we enhance them, providing an extra layer of support with compassion, creativity, and an unwavering commitment to children with medical complexity. What You'll Do: As Clinical Educator with Imagine Pediatrics, you will play a critical role in supporting the clinical development and education of all clinical health professionals. This position involves developing, implementing, and evaluating training programs to ensure the delivery of high-quality, family-centered care. The Clinical Educator will collaborate with interdisciplinary teams to enhance the competencies of clinicians, improve patient outcomes, and ensure adherence to value-based care principles. You will support various learning programs through in-person and remote training. You will: Develop and maintain new hire standards for onboarding and clinical orientation. Collaborate with program and regional leaders to design and deliver robust clinical onboarding experience that focuses on care delivery models, process improvement, tailored services, value-based care, and SDOH. Create, coordinate, and deliver training programs, workshops, and continuing education sessions for team members focusing on evidence-based practices, child/adolescent health, and our integrated care models. Oversee preceptor training by collaborating with clinical staff on current practices, interpersonal skills and EMR training. Create and present educational content with a focus on areas that support business objectives to include but not limited to transitions of care, disease management, and case management. Provide clinical coaching and mentorship to clinical health staff, focusing on skill development, case consultation, and clinical supervision. Foster a culture of continuous learning and improvement. Utilize clinical data, outcome measures, and performance metrics to assess the effectiveness of educational programs and make data-driven recommendations for program enhancements. Assist in the development and revision of clinical policies, procedures, and protocols to ensure compliance with regulatory requirements and alignment with Imagine Pediatrics care model. Create educational materials, guides, and resources for clinicians and families to support understanding of pediatric behavioral health conditions, treatments, and the value-based care model. Provide training for various electronic medical records and software. Design compelling training for wide audiences and skill levels for both online and instructor-led material. Travel to Imagine Pediatrics' offices to train on various content or reinforce adherence to process. This position will require up to 20-30% travel. What You Bring & How You Qualify First and foremost, you're passionate and committed to reimagining pediatric health care and creating a world where every child with complex medical conditions gets the care and support, they deserve. You want an active role in building a diverse and value-driven culture. Things change quickly in a startup environment; you accept that and are willing to pivot quickly to priorities. In this role, you will need: You hold an unrestricted RN and/or NP state license, including board certification, or the ability to become board certified within 2 years. You have strong comprehension of clinical standards of care and are focused on quality of life for your patients. You have proficiency in Microsoft products and general technological savviness. Experience with curriculum design platforms. Experience leading training efforts or as a Clinical Educator. Experience working with a pediatric population strongly preferred, virtual care experience a plus. What We Offer (Benefits + Perks) The role offers a base salary range of $80,000 - $110,000 In addition to competitive company benefits package and eligibility to participate in an employee equity purchase program (as applicable). When determining compensation, we analyze and carefully consider several factors including job-related knowledge, skills and experience. These considerations may cause your compensation to vary. We provide these additional benefits and perks: Competitive medical, dental, and vision insurance Healthcare and Dependent Care FSA; Company-funded HSA 401(k) with 4% match, vested 100% from day one Employer-paid short and long-term disability Life insurance at 1x annual salary 20 days PTO + 10 Company Holidays & 2 Floating Holidays Paid new parent leave Additional benefits to be detailed in offer What We Live By We're guided by our five core values: Our Values: Children First. We put the best interests of children above all. We know that the right decision is always the one that creates more safe days at home for the children we serve today and in the future. Earn Trust. We listen first, speak second. We build lasting relationships by creating shared understanding and consistently following through on our commitments. Innovate Today. We believe that small improvements lead to big impact. We stay curious by asking questions and leveraging new ideas to learn and scale. Embrace Humanity. We lead with empathy and authenticity, presuming competence and good intentions. When we stumble, we use the opportunity to grow and understand how we can improve. One Team, Diverse Perspectives. We actively seek a range of viewpoints to achieve better outcomes. Even when we see things differently, we stay aligned on our shared mission and support one another to move forward - together. We Value Diversity, Equity, Inclusion and Belonging We believe that creating a world where every child with complex medical conditions gets the care and support, they deserve requires a diverse team with diverse perspectives. We're proud to be an equal opportunity employer. People seeking employment at Imagine Pediatrics are considered without regard to race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, marital or veteran status, age, national origin, ancestry, citizenship, physical or mental disability, medical condition, genetic information, or characteristics (or those of a family member), pregnancy or other status protected by applicable law.$80k-110k yearly Auto-Apply 26d agoManager, PVRM
Sumitomopharma
Remote job
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work collaboratively with cross-functional colleagues across the SMPA organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. Job Duties and Responsibilities Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety. Assist in signal detection activities including data assembly, signal validation, and signal evaluation. Perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities. Participate and lead aggregate safety report activities including data compilation and analysis as well as writing of assigned sections (with vendor support.) Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross-functional Safety Management Team meetings. Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and project teams, as required. Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician, including communication with internal and cross-functional team members, submission of data requests, and compilation of analysis and results. Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities. Collaborate with Clinical Development to interpret safety data from ongoing clinical trials. Serve as a subject matter expert in Pharmacovigilance, including operations and medical, within the assigned program. Support collaboration with external partners Key Core Competencies Strong understanding of pharmacovigilance regulations and drug safety reporting requirements Skills in signal detection, risk assessment, and safety data analysis Proficiency with safety databases and software Ability to evaluate and write case reports and prepare regulatory submissions Analytical thinking and attention to detail Communication skills for cross-functional collaboration and regulatory interactions Project management and organizational abilities Ability to work effectively within teams Additionally, experience using tools such as Argus, Oracle, MedDRA, Empirica, and Excel is highly valuable for this position Education and Experience Minimum of bachelor's level degree in a health care/life science related field, with Master's or other graduate degree preferred. Minimum 3 years' experience within Pharmacovigilance and in the pharmaceutical industry. Prior experience in oncology, and/or neurology is strongly preferred. Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It 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. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.$127.9k-159.9k yearly Auto-Apply 60d+ agoRN (PRN)
Evolution Research Group
Columbus, OH
About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I-IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. : The Unit Clinician assists with the conduct of clinical trials through dispensing investigational drugs, the collection of biological samples, performing venipuncture, electrocardiograms, tube labeling, sample processing, documenting in subject charts, and other related tasks in accordance with the doctor's written orders. In executing these responsibilities, the Unit Clinician is guided by Good Clinical Practices (GCP). Responsibilities: Dispense and collect investigational products, routine medications, and PRN medications while subjects are housed on the site observation unit as dictated by written orders. Perform appropriate research protocol procedures which may include but are not limited to vital signs, blood collection and processing, ECGs, and point of care laboratory tests. Perform basic lab procedures including but not limited to preparation of specimen tubes and labels, blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups. Ensure that biological specimens are disposed of appropriately. Maintain a clean, safe work environment. Study, learn and comply with ERG site standard operating procedures, and other policies, practices, and regulations where applicable. Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives. Skills and Qualifications: Education and experience Graduate / completion of approved accredited school of nursing. Education and requirements will be determined by the site need and protocol requirements. Valid License as an RN in the state of practice; maintain current license. Must have a minimum of one (1) year of clinical experience. CPR Certification required, ACLS preferred for RN. Phlebotomy certification (national) preferred. Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines. Communicate with providers, co-workers, and others in a collaborative and courteous manner. Knowledgeable in medical terminology to communicate with physician office and staff. Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change. Requirements Ability to work independently and as a team player. Ability to organize and prioritize within a changing environment. Uses safety/universal precautions to protect self, subjects and staff. Able to appropriately implement protocol and regulatory requirements in study conduct. Proficient in venipuncture, centrifugation, sample storage and performing electrocardiogram. Excellent documentation practices Good organizational and interpersonal skills Attentive to detail, good initiative and able to work with changing priorities.$54k-88k yearly est. 3d ago2026 Co-Op, Strategic Partnerships and Outsourcing
Modernatx
Remote job
The Role: This position offers exposure to the broader clinical development lifecycle, strategic sourcing approaches, and the business, contractual, legal, and financial considerations that drive progress across Moderna's R&D pipeline. As an intern in Strategic Partnerships & Outsourcing (SP&O), you'll be immersed in a dynamic team that supports three core areas: Strategic Partnerships - focused on vendor management and governance Business Analytics - supporting clinical forecasting, budgeting, and site contracting Outsourcing - managing RFPs and contracts for CROs and Global Central Labs (GCLs) This interdisciplinary role offers a valuable opportunity to develop both strategic insight and operational capabilities in a fast-paced, collaborative biotech environment. Throughout your tenure, you'll work closely with experienced professionals who will provide mentorship, guidance, and opportunities to develop both strategic thinking and operational skills. Here's What You'll Do: Gain a foundational understanding of end-to-end clinical outsourcing and vendor governance by assisting with coordination of RFPs, contracts, analysis and benchmarking requests. Strengthen your project coordination abilities through scheduling meetings, drafting agendas, capturing notes, and tracking action items using tools like Microsoft Outlook and Teams. Build operational experience by updating records in the contract management system and generating reports that track contract volumes, timelines, and status metrics. Practice information management by helping maintain structured repositories in SharePoint and Microsoft Teams for contracts, proposals, templates, and vendor materials. Participate in inter- and intra-departmental continuous improvement initiatives as needed. Here's What You'll Need: Minimum GPA of 3.4 Currently Enrolled Junior or Senior Major in scientific, economic, business, or legal discipline At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Here's What You'll Bring to the Table: Superb organizational skills and attention to detail Good verbal and written communication skills Solid technical skills in MS Office Suite applications Must be curious, eager, open to learning, resourceful and independent A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Free premium access to meditation and mindfulness classes Subsidized commuter benefits Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • Discretionary year-end shutdown Location-specific perks and extras! About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. -$85k-165k yearly est. Auto-Apply 60d+ ago