Privacy & Regulatory Assistant General Counsel (Remote)
Myriad Genetics job in Salt Lake City, UT or remote
The Assistant General Counsel - Privacy & Regulatory will work closely with members of the Legal and Compliance Teams in the drafting, implementing, and overseeing the organization's global privacy, regulatory, and legal compliance programs. This individual enables adherence to applicable laws and regulations, including data privacy laws (e.g., HIPAA, CCPA, GDPR, etc.), industry regulatory standards (CLIA, NYS), and internal policies to mitigate risk and protect organizational integrity.
Responsibility
Serve as subject matter expert and internal escalation point for privacy and data protection issues in contracting, sales and marketing, business development and operations.
Ensure the organization has appropriate privacy contract provisions, including DPAs, Business Associate Agreements, Standard Contractual Clauses and Transfer Impact Assessments, if and as required.
Monitor developments in data protection, regulatory, and privacy laws applicable to advanced diagnostics, and develop and lead cross functional project teams to support company compliance.
Provide practical legal advice on data driven projects while anticipating and navigating regulatory and privacy considerations. This includes advising on issues related to data sharing and analytics, mobile applications, and use of artificial intelligence.
Participate in the review of customer-facing materials for alignment with applicable data protection and privacy policies, laws, and regulations.
Oversee and provide legal advice on privacy incident and breach response program.
Provide legal advice on the use of technology within the organization (i.e. enterprise digital marketing, websites, etc.).
Partner with Information Security, Governance/Risk/Compliance (GRC), and Government Affairs on diagnostics regulatory oversight (FDA/CLIA etc.), privacy and cyber related policy/regulation impacting the company.
Create and/or assist with privacy operations management, including, where applicable, DSARs, data mapping, data inventory, records of processing activities, DPIAs and PIAs.
Provide legal advice to support compliance with HIPAA, GDPR, global privacy regulation, and state genetic testing, data breach notification, regulatory and privacy laws.
Provide support for human subject research, IRB protocol, and informed consent review in compliance with the Common Rule and Clinical Trial Regulations.
Provide privacy and regulatory advice in research and commercialization collaborations and M&A transactions and integrations.
Assist in special projects and other duties as assigned.
Qualifications
Juris Doctor degree and bar admission in good standing required.
7-10 years of experience as a licensed attorney in a law firm or in-house required
Minimum of 3-5 years in a role focused on healthcare privacy, regulatory compliance, and risk management required.
License in Utah preferred or ability to obtain Utah license upon hire.
Deep understanding of and demonstrated experience working with HIPAA/HITECH, the Common Rule, GDPR, CAN SPAM/TCPA, 21
st
Century Cures Information Blocking Rules, state comprehensive privacy laws (including CCPA) and emerging US state and global privacy laws.
Experience in the diagnostics industry and working knowledge of CLIA and state regulations related to laboratory developed tests is strongly preferred.
Strong business sense coupled with the ability to provide practical legal advice.
Thorough organizational skills, and resourceful self-starter with excellent problem-solving capabilities, judgment, communication (written and verbal) and interpersonal skills.
Ability to work collaboratively with cross functional teams and provide clear, concise and actionable legal advice.
Understanding and adherence to legal ethics and ability to maintain confidentiality.
Physical Requirements
Lifting Requirements - sedentary work or exerting up to 10 pounds of force occasionally. Physical Requirements - stationary positioning, moving, communicating, and observing. Use of equipment and tools that are necessary to perform essential functions of the job.
EEO
We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.
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#LI-remote
Auto-ApplyReimbursement Specialist, Insurance Billing (Remote)
Myriad Genetics job in Salt Lake City, UT or remote
The Reimbursement Specialist is responsible for collecting on all outstanding balances for a specific group of payors to ensure maximum reimbursement.
. It requires day time hours Monday-Friday.
Responsibility
Responsible for collecting on all outstanding balances for a specific group of payors to assure maximum reimbursement.
Work aged accounts, process appeals and corrected claims, research and reconcile credit balance accounts, and process adjustments as needed.
Interact with payers and management team to ensure timely collections of accounts.
Display exemplary teamwork, professionalism, and time management.
Comply with applicable CLIA, HIPAA, and Compliance standards.
Qualifications
High school diploma or GED equivalent required.
1+ year of experience working in medical billing or revenue cycle required.
Excellent organizational, communication, multitasking, and teamwork skills.
Ability to stay updated on industry trends, regulatory changes, and best practices in medical billing and reimbursement.
Proficiency in medical billing software and electronic health records (EHR) systems.
Working knowledge of ICD-10 and CPT codes.
Physical Requirements
Lifting Requirements -light work or exerting up to 20 pounds of force frequently. Physical Requirements -stationary positioning, moving, operating, ascending/descending, communicating, observing, pushing or pulling, and reaching. Use of equipment and tools necessary to perform essential job functions.
EEO
We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.
Auto-ApplySenior Life Sciences Counsel - Strategic Legal Leader (Remote)
Remote or San Diego, CA job
A leading biopharmaceutical company in San Diego is seeking a Sr. Corporate Counsel to provide legal support across multiple departments including Commercial and Regulatory affairs. The ideal candidate has a Juris Doctorate, over 10 years of experience, and strong skills in contract negotiation and compliance. This role offers a competitive salary, an annual bonus, and comprehensive benefits including health coverage and retirement plans.
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Technical Specialist - Chemistry
Akron, OH job
Smithers is a global leader in delivering trusted analytical testing and consultancy services to a range of industries, including pharmaceuticals, medical devices, and packaging. We are seeking a highly skilled Technical Specialist to join our team in Akron. This is a fantastic opportunity for an experienced professional to provide leadership in Extractables and Leachables (E&L) testing and regulatory consultancy while working with cutting-edge analytical techniques.
What You'll Do:
As a Technical Specialist, you will:
Act as a Subject Matter Expert (SME) in Extractables and Leachables (E&L) regulations, designing and delivering comprehensive analytical testing solutions tailored to client needs.
Develop and lead multi-staged E&L programs, providing expert advice on technical strategies and ensuring compliance with regulatory requirements.
Communicate effectively with clients through various channels (e.g., verbal, video conferencing, written, or in-person meetings) to provide high-quality consultancy and service.
Design and oversee analytical projects using techniques such as LC-MS/UV, GC-MS, FTIR, ICP, UV, conductivity, and pH.
Produce high-quality documentation, including test protocols, reports, and risk assessments, ensuring accuracy and compliance.
Support the development and delivery of technical presentations and workshops at conferences, which may involve international travel.
Stay at the forefront of scientific advancements in E&L, contributing to the growth and evolution of Smithers' services.
Collaborate with internal and external stakeholders to meet project deadlines, budgets, and quality standards.
What We're Looking For:
To excel in this role, you'll need:
A degree in Chemistry, Analytical Science, or a related field (higher qualifications are advantageous).
Extensive experience in Extractables and Leachables testing and/or regulatory consultancy.
Proficiency in a wide range of analytical techniques, including LC-MS, GC-MS, and ICP.
Strong project management skills, with the ability to oversee complex, multi-stage technical programs.
Excellent communication and interpersonal skills, with the ability to build and maintain strong client relationships.
Attention to detail and a commitment to delivering high-quality work.
A proactive approach to continuous professional development in scientific advancements and industry regulations.
Desirable Skills and Experience:
Experience with cGMP, ISO 17025, or equivalent quality systems.
Familiarity with regulatory submissions and risk assessments.
Previous experience presenting at industry conferences or workshops.
What We Offer:
At Smithers, we provide an environment where technical excellence thrives. Our employees benefit from:
Competitive salary and benefits.
Paid time off and holiday pay.
Professional development and career progression opportunities.
A supportive and innovative work culture.
Join Our Team
If you are passionate about delivering technical expertise and are looking for an opportunity to advance your career in a global organization, we'd love to hear from you!
Apply now and make a difference as a Technical Specialist at Smithers.
Smithers is an equal opportunities employer.
#PharmaJobs
SQA Contract Auditor - ISO 9001/ ISO 14001 / ISO 45001 / ISO 13485 / IATF 16949 / AS 91XX / ISO 27001
Akron, OH job
The Quality Assessments Division of Smithers seeks full-time and contract auditors to join our team to assess our clients to management system standards including Quality, Environmental, Occupational Health and Safety, Automotive, Aerospace, and Information Security. If you want to be a part of our mission to provide our clients with accurate data, on-time with high-touch, we would love to have you on board.
Smithers Quality Assessments is a global, accredited third-party Certification Body. Auditors perform assessments and certification activities to verify conformance to management system standards. Responsibilities include ensuring the certification scheme continuously meets the requirements of current industry standards, internal procedures and that of our accreditation requirements. Your goal is to build positive relationships with our clients while providing quality auditing and exceptional client services while maintaining a high level of integrity and impartiality.
QMS/ EMS/ OHSMS Qualifications and/or Experience:
For QMS, EMS or OHSMS auditors: 5 years of work experience with a minimum of two out of those 5 years in quality, environmental or occupational health & safety roles. ISO 9001 / 14001 / 45001 Lead Auditor Certification.
Automotive and Aerospace sector auditors beyond this will be according to SQA qualification and competence requirements, per IATF Rules, and in accordance with ISO/IEC 17021, AS9104/3 and AS9104/1.
ISO 13485 Qualifications:
Has gained experience in the entire process of auditing medical device quality management systems, including review of documentation and risk management of applicable medical devices, parts or services, implementation audit and audit reporting.
Has gained experience by participating as a trainee in a minimum of four audits for a total of at least 20 days in an accredited QMS program, 50% of which shall be against ISO 13485 preferably in an accredited program, and the rest in any other accredited QMS program.
In addition to the criteria above, audit team leaders shall fulfill the following:
Has experience as an audit team leader role under the supervision of a qualified team leader for at least three ISO 13485 audits.
IATF 16949 Qualifications include current 3rd party credentials:
IATF 16949 Auditor credentials (third-party certification) accompanied by an IATF certificate number.
New IATF 16949 Auditor:
Qualified to perform ISO 9001 Audits
Conducted a minimum of six ISO 9001 third-party audits in manufacturing industries with at least three as audit team leader.
Knowledge of automotive Core Tools (at a minimum: FMEA, MSA and SPC) - must have documented evidence of competency was achieved.
Four years full-time appropriate practical experience (including two (2) years dedicated to Quality Assurance and/or Quality Management activities) within the past fifteen (15) years in an automotive manufacturing organization meeting the applicability of IATF 16949. (experience in similar industries may be considered)
Observed a minimum of one (1) IATF third-party audit, excluding special audits, from beginning through the end, lasting a minimum of two (2) days.
AS 91XX Qualifications:
All qualified auditors must have participated in a minimum of twenty (20) audit-days that cover all the elements of AS9100 standard spread over a minimum of four audit sites within the last 3 years.
Work experience requirements preferred include four years in the aerospace industry directly involved in Engineering, Design, Manufacturing Quality or Process Control for a major airframe/spacecraft/space payload manufacturer, prime supplier, auxiliary equipment supplier and/or appropriate NASA, DOD, or FAA organization. In addition, personnel certification required per AS9104/3.
ISO 27001 Qualifications:
Associate auditors - 5 years of work experience with a minimum of 2 years in cyber security implementation or auditing and either an (ISC)2 Entry Level Certification or Associate Membership.
Auditors - 7 years of work experience with a minimum of 5 years in cyber security implementation or auditing and either a CISA, CISM, or ISO 27001 Certificate.
Senior Auditors - 10 years of work experience with a minimum of 5 years in cyber security implementation or auditing and a CISSP with either a CISA or ISO 27001 Certificate.
Auditor competency-based certificates should be demonstrated for support of auditor knowledge.
Four (4) years of full-time appropriate practical experience (including two (2) years dedicated to Quality Assurance and/or Quality Management activities) within the past fifteen (15) years in an automotive manufacturing organization meeting the applicability of IATF 16949.
Associate Chemist II
Columbus, OH job
DUTIES & RESPONSIBILITIES
Collecting, receiving, labeling, and/or analyzing samples using the appropriate testing equipment, in accordance with Smithers CTS OH procedures and state guidelines
Performing analytical testing with SME supervision using instrumentation and procedures including, but not limited to, HPLC, LCMS/MS, ICP-MS, GC-MS, microbiological testing, wet chemistry techniques and extractions, and minor lab equipment
Recording all experimental data and test results accurately in lab notebooks and LIMS systems
Organizing and storing all chemical substances, fluids, and compressed gases according to safety instructions
Ensuring that safety guidelines are followed within the laboratory
Maintaining daily logs and equipment record books
Cleaning, sterilizing, maintaining, and calibrating laboratory equipment
Performing inventory checks and reporting counts to Lab Manager/Lab Director as assigned
Performing sample intake duties as assigned
Performing other minor duties as assigned by management, such as sample disposal and lab/facility cleaning
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#LI-LO1
Operations Support Coordinator - ISS
Akron, OH job
The Quality Assessments Division at Smithers is seeking a detail-oriented professional with strong organizational and scheduling skills to join our team as an Operations Support Coordinator (ISS).
In this role, you will manage and track audit activities for assigned clients and auditors, oversee scheduling and workflow coordination, handle records and data management, support clients, and assist with special projects to ensure smooth operations and high-quality outcomes.
Duties:
Support auditors by preparing and distributing required documentation for audits.
Verify audit packages for accuracy, completeness, and compliance with requirements.
Compile accreditation packages for new and renewal clients; issue certificates.
Schedule new client audits in accordance with industry standards and company procedures.
Confirm audit schedules and maintain compliance with established procedures.
Track and manage non-conformance reports, including correspondence and follow-up.
Distribute Auditor Performance Evaluation forms; record and respond to client feedback.
Process auditor reassignments as needed.
Maintain and update internal and external databases.
Prepare timely quotes for new business and provide budgetary quotes upon request.
Respond to client inquiries professionally and promptly.
Prepare, upload, and conduct monthly audits of CMMC assessments in eMASS (DoD system).
Maintain accurate records through scanning, filing, retrieval, storage, and secure destruction.
Provide backup support for front desk/reception and Operations Assistant functions as needed.
Perform special projects and additional assignments as directed by management.
Must be able to successfully pass a U.S. Department of Defense background investigation.
Required Qualifications:
High school diploma and two to three years of administrative experience, or an equivalent combination of education, training, and experience that demonstrates the ability to perform the duties of the position.
Experience with professional scheduling (e.g., coordinating appointments, managing calendars, or scheduling services) strongly preferred.
Friendly, courteous telephone manners and strong interpersonal skills, with the ability to interact effectively with clients, staff, and field personnel.
Team-oriented with a demonstrated ability to work collaboratively to achieve goals.
Why Smithers?
Variable salary commensurate with experience and qualifications
Medical, dental, and vision benefit plan
401(k) retirement savings plan
Life insurance and AD&D
Short-term and long-term disability coverage
Wellness Program
Employee Assistance Program (EAP)
Business Operation System (BOS) - SQA Audit Management Platform
Training and development support
Hybrid work schedule
Manager of Aerospace Sector
Akron, OH job
The Quality Assessments Division of Smithers is seeking a full-time Manager of the Aerospace Sector to join our team.
As the Manager of the Aerospace Sector, you will oversee and direct all activities within the Aerospace Sector of Quality Assessments (SQA), focusing on developing, applying, and maintaining quality standards / accreditation requirements.
Duties:
Responsible for the oversight, promotion, and performance of activities associated with the Management System and Accreditation Requirements for the Aerospace Sector, including but not limited to, internal witness audits
,
internal audits
,
corrective/preventive actions
,
customer satisfaction
,
continual improvement
,
and management system documentation.
Maintains a working knowledge of government and industry requirements and standards and how they can impact the Aerospace Sector.
Analysis of client and regulatory requirements for the Aerospace Sector and to assess their effect on the internal Management System.
Support of internal/external customers, interested parties, and accreditation body audits (office and witness) for the Aerospace Sector.
Develop training modules and provide training for the Aerospace Sector; this may include staff, auditors, and clients.
Performs internal review of documentation for compliance with stated requirements and makes any necessary updates, deploys, and ensures understanding with appropriate personnel.
Ensures that identified non-conformances are responded to within required timeframes.
Ensure maintenance of external databases and that required metrics are met.
Responsible for approving accurate quotes to the Sales Department.
Determine auditor resourcing needs based on auditor/client location, auditor availability, and auditor effectiveness.
Manages the scheduling of auditors with the support of the Operations Support Coordinator(s).
Managing financial targets and Critical Action Items.
Generate revenue of 60 billable days/year
(including on-site and off-site audit duration and nonconformance verification).
Supervising auditor(s) and Operations Support Coordinator(s) for the Aerospace sector; will be required to work closely with all staff.
Qualifications:
A bachelor's degree is preferable but a minimum of an associate degree (A.A.)
Four years of substantiated work experience in the Aerospace, space, and defense sectors within the last ten years.
Two to four years of experience in a Quality Assurance environment in the Aerospace sector.
Knowledge of Quality Systems requirements. Prefer knowledge of Accreditation Requirements (e.g. ISO 17021 and the Mandatory Document series of Standards).
Knowledge of ISO 9000 and Aerospace requirements (AS91XX, AS9104/XX, and AS9101).
AEA credentials required.
OASIS V3 Knowledge preferred.
US Citizenship Required.
Why Smithers?
Variable salary commensurate with experience and qualifications
Medical, dental, and vision benefit plan
401(k) retirement savings plan
Life insurance and AD&D
Short-term and long-term disability coverage
Wellness Program
Employee Assistance Program (EAP)
Business Operation System (BOS) - SQA Audit Management Platform
Training and development support
Hybrid work schedule
Automotive Aud IATF 16949
Akron, OH job
The Quality Assessments Division of Smithers seeks full-time Automotive (IATF 16949) Auditors to join our Automotive Sector team. If you want to be a part of our mission to provide our clients with accurate data, on-time with high-touch we'd love to have you on board.As an Automotive Auditor, you will support clients through their certification process and assessment activities to verify conformance to management system standards in the automotive industry (IATF 16949). Your goal is to build positive relationships with our customers while providing quality auditing and exceptional client service.
Duties:
Conducting audits to assess compliance with ISO9001:2015 and IATF 16949 standards.
Development and execution of audit plans and reports
Assess client facilities to determine conformity.
Evaluating documentation, processes, and procedures.
Identify non-conformities and areas of improvement.
Maintenance of appropriate records.
Submit expense reports and other critical audit documentation.
Maintain acquired auditor credentials.
Qualifications:
IATF 16949 Auditor credentials (third-party certification) accompanied by an IATF certificate number.
Interested but not certified?
Smithers can assist with your next steps to achieve your credentials!
Qualifications for certification track:
Qualified to perform ISO 9001 Audits.
Conducted a minimum of six (6) ISO 9001 audits in manufacturing industries with at least three (3) as audit team leader.
Knowledge of automotive Core Tools.
Four (4) years full time appropriate practical experience (including two (2) years dedicated to Quality Assurance and/or Quality Management activities) within the past fifteen (15) years in an automotive manufacturing organization meeting the applicability of IATF 16949.
Why Smithers?
Variable salary commensurate with experience and performance
Medical, dental, and vision benefit plan
401(k) retirement savings plan
Life insurance and Accidental death and dismemberment (AD&D)
Short-term and long-term disability coverage
Wellness Program
Employee Assistance Program (EAP)
Business Operation System (BOS) - SQA Audit Management Platform
Training and development support
Flexible work schedule
Inside Sales Representative - GeneSight- Onsite Mason, OH
Myriad Genetics job in Mason, OH
We are seeking a dynamic and driven Inside Sales Representative (ISR) to join our team in Mason, OH. The ISR will play a crucial role in qualifying and selling to healthcare providers, as well as assisting patients throughout their journey. This role involves proactively targeting healthcare professionals to educate them, address their questions, and maintain a strong presence for Myriad within the assigned territory. Our team is dedicated to putting patients' mental health first and driving awareness among healthcare providers.
Responsibilities:
Lead Management: Source new sales opportunities through inbound lead follow-up and outbound cold calls and emails, driven by an inquisitive and competitive mindset.
Customer Engagement: Understand customer needs and requirements to provide tailored solutions, ensuring a consultative approach that prioritizes patient mental health.
Opportunity Management: Route qualified opportunities to the appropriate sales executives for further development and closure.
Sales Achievement: Close sales and consistently achieve quarterly quotas, striving for success by pushing beyond comfort zones.
Account Management: Research existing and prospective accounts, identify key players, and generate interest in our offerings, embracing innovative thinking and collaboration.
Database Management: Maintain and expand your database of prospects and customers within your assigned territory, pushing beyond comfort zones to achieve growth.
Collaboration: Team with sales partners to build a robust pipeline and close deals, fostering a collaborative environment that celebrates success.
Sales Presentations: Conduct engaging virtual sales calls to educate customers and showcase our solutions.
Qualifications:
Education: BS/BA degree or equivalent preferred.
Experience: Prior inside sales experience preferred; healthcare experience is a plus.
Communication Skills: Excellent phone skills with the ability to quickly develop and manage relationships over the phone, embodying a positive and consultative approach.
Adaptability: Agile and able to adapt to rapidly changing external circumstances or internal needs, embracing continuous learning and growth.
Technical Proficiency: Ability to efficiently utilize systems, tools, and data to prioritize tasks and achieve results, including:
Salesforce.com or similar CRM.
Corporate productivity and web presentation tools.
Sales Acumen: Understanding of sales cycles and ability to track related data, holding oneself accountable for achieving results.
Interpersonal Skills: Strong listening and presentation skills, valuing diverse opinions and innovative thinking.
Time Management: Ability to multi-task, prioritize, and manage time effectively, ensuring a balance between professional success and personal well-being.
Physical Requirements
Lifting Requirements - sedentary to light work or exerting 10 to 20 pounds of force frequently. Physical Requirements - stationary positioning, moving, operating, ascending/descending, communicating, and observing. Use of equipment and tools necessary to perform essential job functions.
EEO
We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.
Auto-ApplyInformation Technology Help Desk Analyst
Akron, OH job
The Quality Assessments Division at Smithers is seeking a detail-oriented, customer-focused IT Help Desk Analyst to join our team.
In this role, you will provide technical support to the Quality Assessments Division as well as other divisions across the Smithers organization. Responsibilities include managing service calls and requests from office and auditor staff, troubleshooting Microsoft software (Windows, Office 365, SharePoint), and supporting other applications such as InforCRM and our custom audit operations management system (BOS).
You will also assist end users with general help desk tasks, collaborate with supervisors, managers, and peer IT teams to identify requirements for new features, services, applications, and hardware, and ensure the timely resolution of technical issues. Occasional availability outside of core business hours may be required.
Duties:
Install, configure, deliver, tag, and decommission IT hardware, software, and peripherals.
Image and deploy new computers.
Troubleshoot issues with computers, laptops, mobile devices, and other peripheral devices.
Maintain accurate documentation in the helpdesk ticketing system (SysAid).
Process, communicate, and follow up with users regarding helpdesk tickets, providing timely status updates and assessing customer satisfaction.
Deliver proactive, high-touch help desk support to the Smithers Executive Team.
Coordinate timely repairs, replacements, and/or upgrades of hardware and software.
Perform routine preventative maintenance and patching on SQA hardware and software systems.
Collaborate with vendors for parts replacement and technical assistance.
Assist with the procurement, configuration, and deployment of equipment.
Support network device maintenance (e.g., replacing devices or cabling).
Adhere to established procedures and assist in creating and maintaining documentation.
Partner with IT colleagues from other Smithers divisions to support shared systems and exchange technical knowledge.
Perform other duties as assigned by the Manager of Information Technology.
Required Qualifications:
Associate degree in Computer Science, Information Technology, or a related field preferred.
Industry certifications (e.g., Microsoft, CompTIA, A+) preferred, or an equivalent combination of coursework and experience.
Proficiency with Windows 11 and newer operating systems.
Working knowledge of Apple iOS software.
Experience with Zoom, Microsoft Teams, Multi-Factor Authentication (MFA), Intune (Autopilot), Azure, on-premises Active Directory fundamentals, and network troubleshooting.
Familiarity with SQL reporting or similar data querying tools (preferred).
Experience with vulnerability and patch management tools.
Knowledge of Microsoft Power Automate and Power BI (preferred).
Why Smithers?
Variable salary commensurate with experience and qualifications
Medical, dental, and vision benefit plan
401(k) retirement savings plan
Life insurance and AD&D
Short-term and long-term disability coverage
Wellness Program
Employee Assistance Program (EAP)
Business Operation System (BOS) - SQA Audit Management Platform
Training and development support
Hybrid work schedule
Accounting Associate
Akron, OH job
Are you a detail-oriented individual with a passion for numbers, ready to embrace the future of accounting? Smithers seeks a proactive Accounting Associate to join its innovative team and contribute to its commitment to efficiency, accuracy, and strategic growth. This role plays a key part in maintaining financial health and supporting client relationships across Smithers' divisions. The position handles general accounting functions, with a primary focus on Accounts Receivable, for our Smithers divisions. The primary responsibilities include Accounts Receivable, Collections and General Ledger.
What you'll be doing:
Manage Accounts Receivable across multiple platforms (Dynamics SL, QuickBooks, Sage Intacct)
Prepare, enter, and report Accounts Receivable data for Smithers
Support monthly close activities and assist the Finance Business Partner with closing entries and financial reporting
Reconcile cash and purchasing ledgers and prepare corresponding journal entries
Monitor cash levels and reconcile general ledger cash accounts.
Engage with clients to resolve outstanding balances, update account information, and support timely payments through clear, respectful communication
Strengthen cash flow and client relationships by documenting collection efforts, resolving discrepancies, and reducing aged receivables
Collaborate with internal teams to resolve account discrepancies and ensure smooth payment processing.
Identify opportunities to streamline accounting workflows and enhance efficiency across receivables and reporting processes.
Create weekly and monthly reports to support financial visibility and decision-making
Maintain, update and create Accounts Receivable SOPs to ensure consistency and compliance
Contribute to a fast-paced, collaborative team environment across Accounting and other departments
Support the supervisor and team with various Accounting and administrative duties as needed
Who we are looking for:
3+ years of experience is required
A bachelor's degree in accounting required; or equivalent work experience
Strong understanding of accounting principles and standards
Intermediate knowledge in Microsoft Excel is required (managing and interpreting data, pivot tables, v-lookups, etc.)
Experience with Microsoft Dynamics SL or Sage Intacct preferred; QuickBooks familiarity a plus
Proficiency with accounting software and ERP systems
Exceptional organizational and time management skills
Excellent attention to detail and commitment to accuracy
Effective communication and interpersonal skills
Eagerness to learn new systems and contribute to process improvements is highly valued
Attributes including a customer focus, an entrepreneurial mindset, responsiveness, and a consistently principled approach to their responsibilities
Ability to work effectively both independently and as part of a team
In return, we offer:
Hybrid work schedule
Medical, dental, and vision benefit plan
Paid time off and holidays
401(k) retirement savings plan
Life insurance and AD&D
Short-term and long-term disability coverage
Wellness Program
Employee Assistance Program (EAP)
Ongoing learning and development
About Smithers:
Founded in 1925 and headquartered in Akron, Ohio, Smithers is a multinational provider of testing, consulting, information, and compliance services. With laboratories and operations in North America, Europe, and Asia, we are helping our clients innovate and sell products that change the world.
At Smithers, we foster a collaborative environment where precision, curiosity, and client focus drive everything we do. If you're ready to step into an associate accounting role where your work makes a difference and you're excited to roll your sleeves up and grow with us - apply now.
Medical Science Liaisons (MSL) Director (Biotechnology, Oncology, CA Region)
Remote job
SUMMARY/JOB PURPOSE:
The oncology Senior Medical Science Liaison functions as a highly trained, field-based, scientific expert who engages oncology health care professionals to exchange clinical, scientific, and research knowledge. They build scientific relationships and collaborations. This position interacts with local, regional, and national oncology HCPs, societies and organizations.
Essential Duties And Responsibilities:
Act as the primary point of contact in the field for Exelixis Medical Affairs
Appropriately engage key national and regional thought leaders and healthcare professionals
In an accurate, fair and balanced manner, exchange scientific information with external parties
Intake and manage investigator-initiated study interests
Report field intelligence to Exelixis including competitive information, perspectives about compounds, and the treatment landscape
Provide support to the Exelixis clinical development and operations teams through site recommendations, initiation visits, facilitation of communication, and accrual support activities.
Participate in or lead advisory board meetings
Provide internal and external training
Represent Exelixis at medical conferences and provide session summaries
Within guidelines, provide cross-functional support across the company by being a scientific resource
Develop and maintain a level of knowledge about pertinent studies, compounds, and diseases that would facilitate collegiate and scientific discussions with leading oncology thought leaders
Consistently demonstrate a high standard of excellence in the management of assigned territory while also supporting contributing to the success of colleagues and the MSL organization as a whole
Contribute to the business beyond the borders of a geographic territory on an as-needed basis
Serve as a positive role-model to Associate MSLs
Supervisory Responsibilities:
None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
Master's level oncology PA or NP with active commitment towards completion of doctorate degree, and a minimum of 11 years of related experience; or,
Accredited doctorate degree in a basic-science or life-science discipline (Pharm.D., Ph.D., D.Sc., D.N.P., or D.O.) and a minimum of 8 years related experience; or,
Equivalent combination of education and experience
Experience/The Ideal for Successful Entry into Job:
A minimum of 5 years of MSL experience in therapeutic oncology preferred
Knowledge/Skills:
Ability to travel frequently up to 50%, including occasional weekends
Ability to take and follow directions, accept guidance from management, and adjust quickly to changes
Ability to communicate and engage small and large groups in an engaging manner
Ability to be a strong individual contributor as well as a valued collaborator on a team
Ability to efficiently manage time and priorities
Ability to demonstrate project leadership while recognizing when input from others is needed
Ability to support the achievement of goals while executing all duties in an honest and compliant manner
Travel frequently up to 50%, including occasional weekends
#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $231,000 - $295,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyLong Term Care Regional Specialty Manager - West Texas
Remote job
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (
*in collaboration with AbbVie
)
About the Role:This role leads a sales team promoting life-changing treatments for people with serious neurological, endocrine and psychiatric disorders. The successful candidate recruits and develops a diverse, high-performing team to exceed sales goals within an assigned region while managing key projects and collaborating with commercial cross-functional teams. They provide strategic direction, field coaching, and develop specialty pharmacy fulfillment access strategies. The position requires excellent relationship-building abilities with internal and external stakeholders, impactful communication skills, and the ability to execute successful sales meetings while guiding the team toward effective solutions.
_
Your Contributions (include, but are not limited to):
Leadership & Talent Management
Lead regional sales team by recruiting, developing, and retaining top talent
Provide strategic direction and performance coaching to achieve team excellence
Support team development and ensure proper onboarding of new team members
Strategy & Execution
Drive regional implementation of sales strategies to meet or exceed sales objectives
Develop targeted strategies for psychiatric and neurological markets
Identify regional opportunities and remove barriers to team success
Foster innovative sales approaches and best practices
Performance Management
Analyze sales data and market trends to inform strategic decisions
Hold team accountable for execution of sales strategies and meeting objectives
Consistently spends time with each account specialist in the field to observe and coach performance
Provide regular performance feedback and development opportunities
Business Operations
Manage regional budgets and expenses effectively
Ensure compliance with Neurocrine policies, FDA guidelines, and industry standards
Maintain open communication between field teams and headquarters
Stakeholder Engagement
Is a known entity with key opinion leaders and healthcare professionals within their Region
Develop and maintain relationships with key opinion leaders and healthcare professionals
Engage with local professional and patient advocacy groups
Coordinate with pharmacies and payers to optimize market access
Cross-Functional Collaboration
Align with marketing, training, sales operations and other departments
Requirements:
BS/BA degree AND 8+ years of sales experience in biotech/pharmaceuticals industry, including 3+ years of first-line sales management experience typically acquired through progressively responsible sales roles. Demonstrated track record of successfully building OR
Master's degree preferred AND 6+ years of experience as show above. OR
PhD AND 4+ years of experience as show above
Sees broader organizational impact across departments/divisions
Strong sales disposition and business acumen
Proven sales performance (meeting/exceeding quotas, rankings, recognition awards)
Successful launch experience in complex, competitive environments
Effectively manages change and can act without complete information
Maintains composure under pressure
Strong understanding of healthcare regulatory environment
Entrepreneurial mindset suitable for startup environments
Excellent analytical thinking and problem-solving skills
Intellectual curiosity and ability to challenge status quo
Able to lead through ambiguity and provide team with directional clarity instead of perfect answers
Knowledge of functional discipline best practices and related business concepts
Improves tools and processes within functional area
Developing internal reputation in area of expertise
Leads cross-functional teams and demonstrates leadership skills
Sees broader organizational impact across departments/divisions
Strong computer and technical skills
Excellent communication, problem-solving, and analytical thinking abilities
Manages multiple projects/deadlines with high accuracy and efficiency
Thrives in collaborative, performance-based, fast-paced environments
Adaptable learner who enjoys unfamiliar challenges
Upholds high ethical standards
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.
_
The annual base salary we reasonably expect to pay is $165,600.00-$227,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position is eligible participate in the Company's quarterly incentive compensation plan, which provides the opportunity to earn additional compensation based on individual performance results. This position is also eligible to participate in our equity based long term incentive program.
Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Auto-ApplyTesting Technician (Biomedical/Mechanical)
Akron, OH job
SUMMARY: The technician will handle daily laboratory upkeep and conduct routine equipment checks/maintenance, perform laboratory tests to determine physical characteristics of products and materials in a GMP environment with some supervision, ensure laboratory cleanliness, and conduct preventative maintenance and routine checks on laboratory equipment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Records and stores incoming samples, and maintains storage log.
• Completes assigned testing and tasks in an efficient manner.
• Supports team members to complete testing assignments.
• Is knowledgeable of relative specifications, testing methods, and laboratory practices.
• Maintains record keeping for laboratory assignments and testing to GMP/laboratory standards for audit purposes.
• Follows quality and safety procedures to GMP/laboratory standards.
• Maintains clean appearance of work area.
• Commits to on-time completion of work assignments.
• Undertakes appropriate training and development.
EDUCATION AND/OR EXPERIENCE:
• Associate of Science (AS) or Associate of Applied Science (AAS) degree in Biomedical or Mechanical Engineering
• High School Diploma or General Education Degree (GED); and minimum of one (1) year laboratory experience and/or training may be substituted for the AS or AAS degree.
#MedDeviceJobs #LI-JW1
Aerospace Auditor AS9100D
Akron, OH job
The Quality Assessments Division of Smithers seeks full-time Aerospace (AS91XX) Auditors to join our Aerospace Sector team. If you want to be a part of our mission to provide our clients with accurate data, on-time with high-touch we'd love to have you on board.
As an Aerospace Auditor, you will support clients through their certification process and assessment activities to verify conformance to management system standards in the aerospace industry (AS91XX). Your goal is to build positive relationships with our customers while providing quality auditing and exceptional client service.
Duties:
Conducting audits to assess compliance with AS91XX standards.
Development and execution of audit plans and reports.
Assess client facilities to determine conformity.
Evaluating documentation, processes, and procedures.
Identify non-conformities and areas of improvement.
Maintenance of appropriate records.
Submit expense reports and other critical audit documentation.
Maintain acquired auditor credentials.
Qualifications:
Must have participated in a minimum of twenty (20) audit days that cover all elements of AS9100 standard spread over a minimum of four (4) audit sites within the last three (3) years.
Preferred Qualifications:
Four (4) years work experience in the aerospace industry directly involved in engineering, design, manufacturing quality or process control for a major airframe/spacecraft/space payload manufacturer, prime supplier, auxiliary equipment supplier and/or appropriate NASA, DoD, or FAA organization.
AS9110 and AS9120 experience a plus.
Why Smithers?
Variable salary commensurate with experience and work efficiency.
Medical, dental, and vision benefit plan.
401(k) retirement savings plan.
Life insurance and Accidental death and dismemberment (AD&D)
Short-term and long-term disability coverage
Wellness Program
Employee Assistance Program (EAP)
Business Operation System (BOS) - SQA Audit Management Platform
Training and development support.
Flexible work schedule.
Clinical Practice Liaison - LTC, Mid-South
Ohio job
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
About the Role:
The Clinical Practice Liaison (CPL) builds and maintains clinical/scientific relationships with Advanced Practice Providers (APPs) and other health care professionals, to communicate and advance Neurocrine's scientific position in alignment with Medical Affairs strategy. This role supports educational outreach including disease state pathophysiology, diagnosis, and evidence-based treatment options, with a focus on Long Term Care (LTC) and skilled nursing facilities. "Mid-South" includes all of Indiana, Cincinnati, OH, all of Kentucky, a tiny sliver of MO and IL. Ideal areas for candidates to live: Indianapolis or Cincinnati.
_
Your Contributions (include, but are not limited to):
* Develop and maintain strong clinical/scientific integrity with local, regional, and national advanced practice KOLs plus other HCPs as appropriate to facilitate meaningful scientific discussions
* Identify knowledge gaps across diverse clinical practice settings and provider types to provide appropriate scientific education
* Effectively educate across a continuum that includes disease state, diagnosis and evidence-based treatment aligned with Medical Affairs' scientific narrative
* Partner with national and state professional organizations to support education
* Stay current in latest literature and research within therapeutic area to enable meaningful clinical/scientific interactions
* Identify and recommend research opportunities and project sites
* Serve as a scientific resource and trainer for internal Neurocrine teams
* Collaborate effectively with cross-functional partners to ensure alignment with initiatives
* Attend and provide insights from relevant medical congresses
* Provide feedback on and recommendations for resources to support CPLs in the field (i.e., slides, publications, etc.)
* Complete required reports and assignments with established deadlines
* Other duties as assigned
Requirements:
* Master's degree, NP, CNS, PA or equivalent and 4+ years of similar experience noted above OR
* PhD, DNP, or PharmD degree and 2+ years of similar experience noted above
* Therapeutic Area clinical expertise in Psychiatry or Neurology
* Maintains professional license (ie advanced practice licensure and certification per individual state requirements)
* Ability to represent NBI in a professional manner at all times
* Ability to follow fiscal guidelines and adhere to compliance guidelines
* Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
* Developing reputation inside the company as it relates to area of expertise
* Ability to work as part of and lead laterally on projects
* Exhibits leadership skill and ability.
* Excellent computer skills
* Excellent problem-solving, analytical thinking skills
* Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
* Excellent oral, written and presentation skills
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.
_
The annual base salary we reasonably expect to pay is $160,900.00-$220,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Auto-ApplyIT Functional Analyst
Akron, OH job
IT Functional Analyst - HR
Drive HR Transformation with Technology
Are you ready to make a real impact by blending your passion for technology with the evolving needs of people and culture?
We're looking for an experienced and collaborative IT Functional Analyst to help shape the future of our HR systems. This is an exciting opportunity to work across departments, shape impactful solutions, and be a critical voice in the evolution of our digital network.
What You'll Do:
In this dynamic role, you'll serve as a vital link between our HR teams and IT, using your skills to analyze, design, and implement smart, scalable technology solutions. You'll drive system improvements, support digital transformation, and ensure our HR platforms are not just functional-but adding high value in each of our divisions.
You'll be hands-on across a wide range of responsibilities, including:
Be the Tech Translator:
Work closely with HR stakeholders to understand their needs.
Translate complex business requirements into clear technical specs.
Lead workshops and interviews to dive deep into HR pain points and process needs.
Own Implementation & Integration:
Configure, implement, and support HR systems such as HRIS, payroll, and learning management platforms.
Collaborate with IT to ensure seamless integration with finance, ERP, and other business tools.
Identify and resolve integration challenges.
Lead Change & Ensure Compliance:
Manage system updates, upgrades, and new releases.
Align technology with business goals and compliance standards (e.g., GDPR, HIPAA).
Keep stakeholders informed and supported throughout the change journey.
Deliver Projects with Impact:
Oversee HR tech projects from concept to completion, including budgets and timelines.
Coordinate across internal teams and external consultants to meet goals.
Ensure clear alignment between people, process, and technology.
Collaborate & Communicate:
Work with vendors and external consultants to bring in expert solutions.
Ensure smooth knowledge transfer and alignment on project objectives and deliverables.
Facilitate training sessions and create learning materials for HR users.
Enable Data-Driven Decisions
Ensure accurate data flow across HR platforms and systems.
Help HR teams generate reports and dashboards to analyze key HR metrics, employee data, and performance insights.
Ensure integration of data across systems for comprehensive reporting and analysis.
What You'll Bring:
A Bachelor's degree in Information Technology, Business Administration, or a related field.
3+ years' experience in a similar role (IT Functional Analyst, Systems Analyst, Business Analyst).
Experience with HRIS systems is essential, experience with UKG is preferred.
Familiarity with data management, analytics tools, and reporting platforms (e.g., Power BI, Tableau).
Experience with system administration tasks, including user access control, software updates, and system maintenance.
Familiarity with cloud-based technologies and SaaS platforms.
Understanding of web technologies, APIs, and system integrations.
Experience with system administration and management of user roles in tools.
Proven experience working with external consultants and cross-functional teams.
What We Offer:
Hybrid work flexibility - enjoy the best of both remote and in-office collaboration, with 2 days from home and 3 days in our Akron office.
A collaborative and forward-thinking team environment.
The chance to make a real difference in how our people experience HR.
Professional growth opportunities and in a growing Global organization.
Ready to Join Us?
If you're passionate about bridging people, processes, and technology, and want to be part of a company that values innovation and impact-this is your opportunity.
#LI-KE1 #AnalystJobs #HR #LI-Hybrid
Manager, Statistical Programming
Remote job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Gilead and help create possible, together.
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Manager, Statistical Programming, at Gilead you will ...
Exhibit strong statistical & programming knowledge & expertise to influence key decisions on statistical programming outputs and provide guidance to statistical programmers.
Attend SMT Meetings, providing functional input on programming related activities and potential risks.
Review and approve statistical programming requirements (e.g. ADaM Mapping Specifications).
Communicate SMT decisions, discussions, and action items to statistical programmers.
Review and approve key study documents.
Help statistical programmers understand critical study documents.
Review statistical programming timelines and negotiate with study team if needed.
Participate in internal and external audits and identify areas of opportunity to refine and simplify procedural steps.
Analyze vendor performance through assessment of Key Performance and Quality Indicators (e.g. KPI, KQI), metrics, and results.
Participate as needed in vendor governance discussions to address any performance related risks and/or concerns.
Ensure adequate statistical programming resourcing for study milestones.
Assign tasks to statistical programmers based on experience and ability.
Closely monitor and track study statistical programming activities within task management system.
Maintain regular communications on study statistical programming milestone activities with appropriate study team members and stakeholders.
Influence and support data and submission standards, templates, etc.
Perform quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards.
Ensure programming activities are executed in correct order.
Ensure validation documentation, folder locking, and TMF requirements are observed.
Surface the need for new or updated standards to improve efficiency and uniformity across TA or Indication level objects.
Provide prioritization decisions and coaching to fellow onboarding staff as needed to advance their knowledge on Gilead processes and statistical programs & methods.
Ensure the programming team identifies data issues and enters accordingly into the Data Issue Log. In addition, ensure all issues and observations noted on the issue log have been resolved prior to final production release.
Hold analysis team meetings with Biostatisticians.
Serve as the point-of-contact with vendors, and liaise with other functions.
Request the locking and archiving of study folders.
Overview:
To achieve the commitments of our clinical portfolio, CDS has been developing an agile and sustainable resource model that leverages external partnerships to form a strong alliance with internal Gilead roles. Together, these teams will deliver statistical programming outputs that meet study analysis needs and requirements. The Analysis Oversight Statistical Programming (AOSP) Lead is essential to these partnerships. As a member of the Study Management Team (SMT), the AOSP Lead works closely with the study team to determine the statistical programming requirements, understand study milestones and programming dependencies, and leads the development of the programming outputs.
The AOSP Lead is accountable for the development of Analysis Data Model (ADaM) and Table, Figure, and Listing (TFL) deliverables, ensuring completeness, accuracy, and compliance with regulatory and quality standards. This role will progressively review vendor performance metrics in governance meetings to monitor trends and address any challenges, risks, and/or bottlenecks encountered by the study programming team.
The position requires a strong acumen in statistical analysis, focused on achieving high-quality outputs that support clinical results. In addition, the candidate will need to perform quality management, coach and mentor programming colleagues, and provide statistical guidance as it relates to specifics of the study and general processes and statistical program education. The candidate will need to closely monitor the quality and timeliness of clinical trial programming deliverables, provide process guidance, support creation and maintenance of onboarding materials, and direct prioritization and coordination of study related deliverables.
Qualifications:
BS degree in Biostatistics/Computer Science or equivalent with 6+ years of experience OR
MS degree in Biostatistics/Computer Science or equivalent with 4+ years of experience OR
PhD degree in Biostatistics/Computer Sciences or equivalent with 0+ years of experience
Experiences leading late phase HIV studies in Virology TA.
Mature statistical knowledge and expertise in the development of ADaM and TFLs and dependent tasks/activities.
Proven track record in delivering high quality statistical programming datasets and outputs.
Ability to collaborate and work effectively with global team members and build strong relationships.
Expertise working in global teams, across various time-zones to achieve clinical trial milestones.
Remains current and has deep knowledge of GCP, ICH guidelines, and regulatory requirements, specifically as it relates to quality oversight, quality assurance, and risk management.
Ability to problem-solve using data-driven approaches to help determine the best path forward.
Excellent customer-focus with proven track-record in building relationships through superlative communication and writing skills.
Superior skills in coaching and mentoring staff of varying skillsets and respectful of cultural differences especially communication styles.
Results-oriented and able to work closely with others through great collaboration to resolve challenges, bottlenecks, or risks.
Ability to motivate large diverse teams to achieve a common set of goals.
Strong experience in data analysis and demonstrated critical thinking skills.
Deep knowledge in HIV study designs and analysis requirements.
Able to lead and mentor effective cross functional teams and keep programming team promptly informed of all study activities.
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $133,195.00 - $172,370.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplyNeuroPsych Account Specialist - Fort Worth TX
Remote job
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (
*in collaboration with AbbVie
)
About the Role:Responsible for a specific geographic territory and the successful promotion and growth of Neurocrine products. Manages and develops long-term relationships with physicians and other customers for targeted accounts in their assigned territory and represent Neurocrine brand(s) and their approved indications. This role also plays an important part in educating external customers such as physicians, nurses, medical assistants, case managers, etc. and helping them learn about the benefits of our product(s).
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Your Contributions (include, but are not limited to):
Sales and Market Development
Drives product acceptance and growth through targeted education and strategic account management
Executes territory sales strategies to meet or exceed objectives via in-person and virtual communications
Identifies and addresses territory-specific opportunities and barriers to product success
Effectively manages promotional resources and budget
Customer Relationship Management
Builds and maintains relationships with key stakeholders including:
Healthcare providers (Psychiatrists, Neurologists, NPs, PAs)
Clinical staff (RNs, LPNs, PharmDs)
Key opinion leaders and advocacy groups
Community Mental Health Clinics and Long Term Care facilities
Local/regional payers and pharmacies
Cross-Functional Collaboration
Establishes excellent communication with internal partners including managed care, Marketing, Patient Access, Medical Science Liaisons, and medical communications teams
Professional Standards
Upholds highest ethical standards, including FDA guidelines and pharmaceutical industry best practices
Demonstrates integrity and models behaviors consistent with company values and compliance policies
Work Expectations
Maintains full field presence Monday-Friday with flexibility for occasional evening/weekend events
Other duties as assigned
Requirements:
BS/BA degree in science or related field AND Minimum of 4 years of commercial pharma/biotech or related experience, including 3+ years of specialty pharmaceutical or LTC, Psychology, or Neurology sales experience is highly desired. Close-door or specialty pharmacy distribution experience is strongly preferred. Psychiatry, neurology or antipsychotic experience strongly preferred. Experience with business systems, salesforce automation platforms, and other business intelligence tools (e.g., Salesforce.com, Oracle database, SAP, Business Objects, COGNOS, QlikView, Veeva, etc.) OR
Master's degree in science or related field AND 2+ years of similar experience noted above
Professional Expertise
Knowledge of best practices in the functional discipline and broader related business concepts
Strong understanding of healthcare regulatory and enforcement environments
Proven track record of meeting/exceeding sales objectives and launch success in complex environments
Developing internal reputation in area of expertise
Continuously works to improve tools and processes
Leadership & Teamwork
Ability to lead and participate in cross-functional teams
Exhibits leadership skills, typically directing lower levels and/or indirect teams
Builds trust and support among peers
Acts as a settling influence in challenging situations
Technical Skills
Strong computer skills and working knowledge of business systems
Proficiency with sales platforms and business intelligence tools (Salesforce.com, Oracle, SAP, Veeva, etc.)
Excellent project management abilities
Critical Thinking
Sees broader organizational impact across departments/divisions
Excellent analytical thinking and problem-solving skills
Intellectual curiosity and ability to challenge status quo
Able to decide and act without having the complete picture
Communication & Relationship Management
Excellent verbal and written communication skills
Strong sales and account management disposition
Ability to navigate complex accounts across varied care sites
Understanding of specialty fulfillment and payer requirements
Personal Attributes
Results-oriented with high ethical standards
Adaptable and effective in managing change
Ability to meet multiple deadlines with accuracy and efficiency
Thrives in performance-based, fast-paced environments
Versatile learner who enjoys unfamiliar challenges
Derives satisfaction through purposeful, passionate work
Entrepreneurial attitude/experience
Job-Specific Requirements
Should reside within the geographic area of the assigned territory
Valid driver's license and clean driving record (position requires frequent driving)
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.
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The annual base salary we reasonably expect to pay is $123,100.00-$168,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position is eligible participate in the Company's quarterly incentive compensation plan, which provides the opportunity to earn additional compensation based on individual performance results. This position is also eligible to participate in our equity based long term incentive program.
Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
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