Exact Sciences Jobs in Usa

Summary:

The Admissions and Student Affairs Coordinator plays a crucial role in supporting the Assistant Dean of Student Affairs and Enrollment and the Master of Science in Biomedical Sciences Program (MSBS) at the College of Biosciences and Health Professions. The coordinator position assists with the student onboarding process and student engagement activities, maintains admissions and student data, and helps drive enrollment initiatives for the Master of Science in Biomedical Sciences (MSBS) program while providing administrative and clerical support to the Office of Student Affairs and Admissions. Additionally, the coordinator will travel to recruit students and help achieve enrollment goals. The ideal candidate should possess excellent organizational skills, strong communication skills, and the ability to work collaboratively with faculty, staff, and students.

Responsibilities

Admission & Recruitment:

• Coordinate MSBS recruitment and admissions activities (interview days, open houses, information sessions, and outreach events)
• Maintain applicant files in PostbacCAS/WebAdMIT
• Provides database input and generating reports; collaborates with CHSU COM (College of Osteopathic Medicine) for pipeline initiatives.

Student Onboarding & Engagement:

• Oversee pre-matriculation processes including background checks, SONIS setup, and orientation logistics;
• Ensure smooth onboarding and communication for incoming students.

Student Affairs & Engagement:

• Support student life, wellness, and professional development activities;
• Assist with coordinating of community service and co-curricular events;
• Assist student organizations and graduation ceremonies while promoting inclusion and student success.

Administrative & Operational Support:

• Planning, scheduling, and coordinating meetings, taking meeting notes, setting agendas, and other clerical duties.
• Monitors student affairs and admissions email inboxes for RSVPs, new inquiries, and general questions and appropriately routes the emails.
• Maintains office supplies and inventory for the Office of Student Affairs & Admissions.
• Maintain relationships with vendors and assist with catering orders and events.

Qualifications

Education:

·      Associate degree required; bachelor’s Degree preferred

Skills & Experience:

• Two or more years of related work experience and/or relevant training.
• Ability to maintain confidentiality, exercise good judgment and act professionally, sensitively, and with a high level of discretion Ability to exercise good judgment and act professionally, sensitively, and with a high level of discretion.
• Superior organizational skills and attention to detail; ability to multi-task and work with deadlines; keep track of multiple projects and ensure timely follow-up.
• Ability to keep track of multiple projects and ensure timely follow-up.
• Strong research and analytic skills.
• Ability to work effectively with colleagues and students by practicing punctuality, respect for deadlines, and collaborative problem solving.
• Has positive regard for others in written, verbal, and non-verbal communication and student service skills, including the ability to maintain good relations with the University community.
• Proficiency in Microsoft Office Suite required.
• Self-motivated and able to work independently with minimal supervision.
• Demonstrated ability to learn new technological skills.
• Maintain proficiency as needed and approved by attending trainings.

Benefits:

Hourly Rate: $20.67- $27.00

Vacation: 2 weeks

Sick Time Off: 3 weeks

Holiday Time off: 14 paid holidays

Winter Shutdown: Paid time off from December 26th- December 31st

Medical Benefits

Dental Benefits

Vison Benefits

4% 401K match

Tuition Reimbursement

1 day remote after 6 months of employment

QC Supervisor

Kelly® Science & Clinical is seeking a QC Supervisor for a direct-hire position at a cutting-edge client in Fort Collins, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Location:Ft. Collins, CO (onsite)

Shift: 1st or 2nd

Salary: $100-105,000 + Benefits

Essential Duties & Responsibilities

• Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items.
• Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
• Escalate and communicate items which arise per the timelines specified in the department escalation strategy.
• Execute all business and department goals and initiatives on time.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
• Issue all Certificates of Analysis within 2 business days of last test completion.
• Generate, monitor and report weekly team and analyst KPIs.
• Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples.
• Strive to balance workload across all sites and teams to ensure adequate resource allocation.
• Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time.
• Provide assistance, training and leadership for direct reports through utilization of the OTD resources.
• Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix.
• Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals.
• Create and revise developmental plans to help employees grow their skills and advance their careers.
• Monitor and discuss progress of employee’s performance, growth and development in one on ones utilizing the career ladder and KPIs.
• Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates.
• Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days).
• Support and execute all potential 3-day field alert investigations and actions expeditiously.
• Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
• Ensure all samples logged into the LIMS system are submitted correctly.
• Identify, and complete cost savings initiatives and facilitate continuous improvement.
• Participate in leadership development activities and take an active role during department and company activities.
• Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
• Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues.
• Conduct and coordinate laboratory investigations, and all associated actions.
• Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports.
• Participate in project teams, company and department meetings, third party audits, and regulatory audits.
• Monitor departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Participate in the interview and selection process for candidates, as required.
• Perform other duties as required by business demands.

Knowledge, Skills & Abilities

• Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality.
• Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively
• Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in analytical method validation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department.
• Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.
• Knowledge of analytical troubleshooting and product investigation.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,.
• Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use.
• Ability to coordinate activities to assure customers’ needs are met in terms of sample analysis cycle time.

Education & Experience

• Bachelor’s degree in science, preferably in Chemistry or Biochemistry, or Microbiology.
• 6+ years’ experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting.
• Supervisory or team lead experience is preferred.

What Happens Next

Once you apply, you’ll move forward to next steps if your background aligns with the role. If not, no worries — you’ll remain in our network, giving our Science & Clinical recruiting team access to your profile, helping open the door to future opportunities.

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

Job Title: QA Validation Specialist (Contract)

Duration: 10 months

Location: Irvine, CA (onsite)

Rate: $38–40/hr.

This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

• Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
• Authors/approves and executes qualification protocols and reports.
• Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
• Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
• Qualification of Vendors Selected.
• Input to the development of the URS/FRS/DDS.
• Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
• May present qualification studies to Regulatory and Client Auditors as required.
• Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
• Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
• Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
• Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
• Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
• Other responsibilities and special projects will be assigned based on business and customer needs.

QUALIFICATIONS:

• Bachelor’s degree in Sciences
• 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
• Strong working knowledge of cGMP and regulatory standards for validation.
• Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
• Demonstrated experience with qualification of commercial processing a packaging equipment.
• Proven track record of managing projects from start to finish on time and on budget.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

Mission Driven, Community Focused About | Charles R. Drew University of Medicine and Science ( )

Charles R. Drew University is located in the Watts-Willowbrook area of South Los Angeles and was founded in 1966 in the wake of the Watts uprising. CDU was founded to address inadequate medical care in the region and to provide equitable medical education opportunities for underrepresented students.

CDU is strongly invested in the local and regional community. The university leads multiple partnerships and programs to provide equitable healthcare resources in a variety of South Los Angeles neighborhoods.

Under the supervision of the Assistant Vice Provosts of Student Affairs, the Career Advisor helps students reach their educational and career goals by providing career counseling to undergraduate and graduate students. They will coordinate and provide career advising. Career counseling responsibilities are to assist students in developing competencies required to become informed about the choice of a major and career, and to make informed decisions related to their professional goals. Work is performed under general supervision, and performance is based upon completion of assignments and results obtained.

Higher Education Experience is REQUIRED for this role.

Essential Duties and Responsibilities:

• Provides individual and group career advising through one-on-one meetings, group settings, and college outreach in accordance with NACE standards.
• Demonstrate that students are meeting the requisite competencies that broadly prepare clinicians and undergraduates for work after the attainment of their degree. Competencies are met, such as when a student has the skills to apply, interview, and attain a position.
• Provides assistance and assessment of student aptitudes, abilities, strengths, interests, and selects appropriate career goals, and implements corrective measures to alleviate any deficiencies.
• Conducts career advisement workshops, including but not limited to resume writing, networking, interviewing skills, and other career-oriented material.
• Implement a career and internship fair every fall and spring semester with alumni/ae of Charles R. Drew University and community partners.
• Provide potential opportunities for students to network and shadow medical professionals, and visit future job sites.
• Facilitate a pipeline program that helps cultivate and develop students from freshmen to seniors.
• Recommend, administer, and interpret standardized career assessment inventories.
• Provides occupational information and maintains the career resource library and online website.
• Assist and participate in the formulation and implementation of organizational goals and objectives. Participate in regular department and component meetings.
• Participate and support student life activities, including orientation activities for new and returning students.
• Maintain effective communication and provide high-quality customer service to potential employers, faculty, staff, students, and community members.
• Create effective marketing strategies and materials to increase participation in Career Advising services and initiatives.
• Complete other duties as assigned by the Office of the Provost.

EDUCATION:

• Bachelor’s degree or above in education, counseling, or general subject area of advising and five years’ experience in advising, recruiting, teaching, coaching, and Student Affairs or other related area.
• Master’s degree preferred.

MINIMUM EXPERIENCE/QUALIFICATIONS:

• Two (2) years of post-graduate experience in academic and career advising.
• Experience working with undergraduate and graduate students in support of their career development.
• Demonstrated interest and experience in working with a student population that is diverse in terms of race, language of origin, ethnicity, nationality, religion, generation to college, sexual identity, abilities and interests.
• Strong written and oral communication skills.
• Experience in advisement within a higher education setting.

DESIRED EXPERIENCE/QUALIFICATIONS:

• Experience planning, coordinating, and facilitating outreach programs.
• Knowledge of career exploration, demonstrated ability to work with students from diverse, ed. disadvantaged and non-traditional backgrounds.

KNOWLEDGE/SKILLS/ABILITIES:

• Ability to provide and analyze statistical data for periodic and end of year reporting.
• Excellent communication, interpersonal, and customer service skills.
• Demonstrated database management skills.
• Ability to establish priorities, meet deadlines, and attain growth-oriented goals.

COMPUTER SKILLS:

• Must possess excellent computer skills and be proficient in MS Windows, Word, Excel, etc.

Compensation:

• $28-$31 per hour

Position Status:

• Full-Time, non-exempt

COMPLEXITY:

• The ability to perform highly detailed work with sustained attention and care while providing/obtaining information on numerous inquiries is paramount to success in this position.

WORK ENVIRONMENT:

• Variable work environments including non-traditional service areas.
• May work in cramped, crowded quarters.
• Position is on-site unless specific authorization from the manager.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• This position requires the ability to travel to remote locations and to load and transport admissions materials, displays, and other equipment.
• Some evening and weekend hours required, especially during orientation and examination seasons.
• Sitting and standing for extensive periods of time.
• Walking, stooping, reaching, climbing high and low levels.
• Lifting up to 25 pounds; carrying materials to various locations.
• Finger and hand movement and feeling sufficient for computer and equipment operations.
• Clear speaking, hearing conversationally, and seeing near and far.

MENTAL DEMANDS:

• The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Frequent variety of unrelated tasks. Constant calculating, interrupted work, a variety of interrelated tasks, and use of sustained concentration, reasoning, judgment, resourcefulness, analytical ability, and ingenuity

Special Requirements:

• Ability to work effectively with a diverse community.
• As a health professions institution of higher education, Charles R. Drew University of Medicine and Science seeks to protect the health and safety of the University community. As a condition of enrollment and employment, students, faculty, and staff must comply with the current CDU COVID-19 requirements as described on the CDU COVID-19 webpage. Please visit the CDU Return to Campus website or email the Campus Nursing Office at
• Conditional Employment:
• The employment status of this position is classified as “Conditional.” Conditional employment means that the job exists contingent upon continued funding and limitations of restricted funds or, the duration of a specific program, project, grant, or contract. Since your salary is funded by Title III and end date of 9/30/2026, your position is contingent upon the continued receipt of these funds. Continuation of your position is dependent, in part, upon funding availability. Furthermore, no work may be performed after the grant end date(s) unless you have received an extension in writing from a Dean, Division VP, or Human Resources.
• EEO Statement: Charles R. Drew University is committed to Equal Employment Opportunity. Applicants will be considered without regard to gender, race, age, color, religion, national origin, sexual orientation, genetic information, marital status, disability or covered veteran status.
• Fair Chance Statement: Charles R. Drew University of Medicine and Science will consider qualified applicants, including those with criminal histories, in a manner consistent with state and local “Fair Chance” laws.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.

Mesmerize, the leader in out of home advertising, is seeking a focused, structured, and motivated Customer Service Representative. The ideal candidate will thrive in a fast-paced, concurrent deadline environment. The Customer Service Rep will be highly focused, detail oriented, and capable critical thinking in a high-pressure environment.

For fifteen years, Mesmerize has maintained an entrepreneurial spirit and is in a rapid growth mode in the out of home and point of care vertical. We seek a true team player that has the fire and desire to help us grow, and grow their own skills in a fast paced, fun environment. Mesmerize team members are passionate, focused and dedicated to the markets and customers that we serve, and we expect new team members to contribute and share their knowledge and skills at 100%. If this role excites you, we encourage you to apply for this unique position.

Duties and Responsibilities

• Minimum of 70 outbound calls per day.
• Follow communication scripts & understand products being offered prior to calling.
• Receive calls & answer questions from medical offices.
• Identify customers' needs, clarify & update account information.
• Build sustainable relationships & engage customers by going the extra mile.
• Multitasking, effective time management, & pivoting when needed.
• Follow up on materials being delivered.
• Be open-minded & coachable for growth improvement.

Skills and Requirements

• Bachelor's Degree preferred.
• Minimum of 2 years outbound B2B calling.
• Computer efficiency with Microsoft Office.
• Salesforce experience preferred.
• Avaya phone experience a plus.
• Good team player with desire to work collaboratively with operations and management.
• Meet daily/weekly/monthly performance metrics.
• Self-motivated, energetic, and creative
• Strong communication skills; both verbally and in writing
• Active listener
• Excellent attention to detail

Compensation

• Mesmerize offers a competitive compensation plan, health benefits, and the opportunity to work with a dynamic and fun team
• Salary commensurate with experience

MJH Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. All employees of MJH Life Sciences are employed "At Will." This means that either the employee or the Company is free to end the employment relationship at any time, for any reason, with or without cause and with or without notice.

SANY'S Syracuse Academy of Science Middle School is excited to announce the immediate opening of a Night Cleaner (PT).

Main responsibilities and tasks:

1. To be responsible for cleaning certain parts of the school as allocated by the Operations Manager and following Health & Safety guidelines.

2. The safe use of chemicals and cleaning materials as instructed by the Operations Manager following Health and Safety guidelines and the use of Personal Protective Equipment (PPE)

3. To operate cleaning machinery in cleaning soft and hard surfaces, eg. vacuum cleaners and polishers following Health & Safety guidelines.

4. To maintain all School standards of hygiene and safety of all Cleaning equipment and Cleaning Closets in your charge.

5. To report any hazards, defects and any relevant factors of breakdowns of equipment that may be detrimental to safe working practices, immediately to the Operations Manager.

6. Duties to include the following:

Vacuum cleaning hard and soft floors

Spot cleaning of spillages

Wiping furniture, ledges, pipes, paintwork, doors and polishing door glass

Emptying and cleaning bins

Cleaning toilets including sanitary fittings and surrounds

Mopping and spray cleaning hard floor surfaces

Wiping and polishing and straightening furniture

Replenishing janitorial supplies in toilets, etc.

Checking and closing windows, switching off lights after work

Such other duties as may be allocated from time to time

Notes: During periods when the school is closed, routine cleaning is undertaken throughout the school. This may include stripping and sealing floors, high-level dusting, wall washing, etc. Other duties as requested.

Equal Opportunity Employer Science Academies of New York is committed to maintaining a working and learning environment free from discrimination on the basis of race, color, religion, national origin, pregnancy, gender identity, sexual orientation, marital/civil union status, ancestry, place of birth, age, citizenship status, veteran status, political affiliation, genetic information or disability, as defined and required by state and federal laws. Additionally, we prohibit retaliation against individuals who oppose such discrimination and harassment or those who participate in an equal opportunity investigation.

Requirements

Qualifications:

Fingerprint clearance through the NYS Department of Education

Location:

This is a hybrid role and requires 3 days in the office in Ann Arbor, Michigan.

Who We Are:

The National Center for Manufacturing Sciences (NCMS) is a cross-industry technology development consortium, dedicated to improving the competitiveness and strength of the U.S. industrial base. As a member-based organization, it leverages its network of industry, government, and academic partners to develop, demonstrate, and transition innovative technologies efficiently, with less risk and lower cost.

NCMS enables world-class member companies to work effectively with other members on new opportunities – bringing together highly capable companies with providers and end-users who need their innovations and technology solutions. NCMS members benefit from an accelerated progression of idea creation through execution.

Job Purpose:

The Business Operations Specialist is responsible for supporting diverse projects and other business activities while providing exceptional customer service.

Primary Responsibilities:

• Maintain data integrity and accuracy through validation, which will likely include comparison to and review of official NCMS documentation.
• Collaborate with various business units to understand processes and collect data.
• Maintain and assist in the creation of content for internal and external communications.
• Respond to internal and external customer requests as needed. Identify customer needs and collaborate with internal NCMS departments.
• Provide project meeting support as needed via attending meetings, preparation and distribution of project meeting notes. Assist in the documentation and improvement of procedures.
• Assist in preparation and/or review of quarterly and final project reports.
• Maintain project information, collect and maintain data files/folders, develop presentations.
• Become trained and proficient in specified core functions within the organization.
• Perform other duties as requested.

Requirements:

• Must be a citizen of the United States.
• Must have or be eligible to obtain government security clearance.
• Must be fully vaccinated against COVID-19 unless legally exempt.
• Flexibility to work a hybrid schedule; three days in the office & two days home.
• Degree in Business Administration, Science/Technology or related field or a minimum of 5 years’ experience in an administrative role with customer service and/or technology focus.
• Critical thinking & problem-solving skills are required.
• Microsoft Office 365 experience.
• SharePoint functional knowledge.
• Effective communicator in written and oral formats.
• Demonstrated high level of organization and attention to detail.
• Demonstrated ability to develop and deliver suggestions for process improvements.
• Demonstrated customer service excellence.

This position is contingent upon the successful completion of a background screening, which may include checks for criminal history, driving records, financial history, and education verification, as permitted by law.

NCMS IS AN EQUAL OPPORTUNITY EMPLOYER

Key Responsibilities

• Document Leadership and Authoring:
• Provides medical writing leadership for clinical programs
• Acts as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and protocol-related documents (e.g. informed consent forms), clinical study reports, DSURs, Investigator’s Brochures, IND clinical summaries/overviews, and CTD components (e.g. Module 2 summaries)
• Partners with the regulatory function to ensure timely completion of high-quality regulatory documents including health authority meeting requests, briefing packages, responses to requests for information, and other documents as required for submissions
• Vendor Management: Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activities
• Process Improvement:
• Develops medical writing best practices
• Partners with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes and all clinical documents to ensure compliance with ICH requirements

Position Requirements

• Master’s degree in a life science discipline from an accredited college or university; PharmD or PhD preferred
• Minimum of 8+ years of scientific or medical writing experience at a biotech/ pharmaceutical company or clinical research organization setting
• Expert knowledge of standard clinical regulatory document types and associated regulatory requirements (e.g. ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations, etc.)
• Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator’s Brochures, IND clinical summaries/overviews, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study Trials
• Expert ability of Microsoft Office Suite, Adobe Acrobat, collaborative review management systems (e.g. SharePoint) and documents management (e.g. Veeva RIM)
• Experience in resource planning and management experience of contractors
• Excellent organization skills with a passion for delivering quality results
• Detail-oriented mindset with excellent verbal and written communication skills
• Self-motivated and able to work collaboratively
• Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude
• Must be willing to work onsite at least 4 days a week

Title: Senior Account Executive

Location: Remote, Morristown, NJ (In office once a month for an All-staff meeting)

Job Type: Full Time

About our client:

Our client is a boutique healthcare public relations agency with a strong purpose at its core, partnering with some of the most prominent names in the life sciences industry. Their work focuses on bringing innovative therapies to market, increasing awareness around important disease areas, and shaping compelling stories that highlight advancements in healthcare.

Overview:

As a Senior Account Executive, you will play a key role in supporting and driving client initiatives, mentoring junior team members, and approaching projects with a proactive, solutions-focused mindset. This opportunity is ideal for someone who is eager to develop professionally, thrives in an organized environment, and is ready to take ownership of dynamic healthcare communications campaigns.

You will become part of a tight-knit, collaborative team that combines strategic expertise with a genuine passion for making a meaningful impact in health.

Key Responsibilities

Client Engagement & Strategy

• Act as a primary point of contact for day-to-day client communication, delivering high-quality service and responsiveness
• Conduct detailed research to inform strategic planning and deepen client partnerships
• Develop a strong understanding of client products, key opinion leaders, and the competitive healthcare landscape

Project & Campaign Delivery

• Manage project logistics across events, campaign deliverables, media initiatives, and vendor coordination
• Ensure timelines, quality standards, and budgets are effectively managed and met

Media Relations

• Pitch and secure meaningful media coverage across both healthcare and consumer media outlets
• Create targeted media lists, craft compelling story angles, and coordinate spokesperson opportunities
• Monitor media activity and produce performance reports

Content Development

• Produce a variety of communications materials including press releases, briefing documents, pitches, and other PR assets
• Translate complex medical or scientific information into clear, accessible messaging

Team Collaboration & Financial Oversight

• Provide guidance and mentorship to junior team members
• Assist with budgeting processes, financial trackers, and expense management
• Contribute to new business initiatives through research, strategic ideas, and presentation support

Qualifications

• Bachelor’s degree in Communications, Public Relations, Journalism, or a related discipline
• 3-4 years of experience in public relations, ideally within healthcare or life sciences
• Strong writing, editing, and storytelling capabilities
• Solid understanding of media relations strategy, trends, and industry tools
• Proficiency in Microsoft Office; familiarity with social media platforms is advantageous

Kelly® Science & Clinical is seeking a Document Control & Training Manager for a Direct Hire position at a leading specialty pharmaceutical company in Sacramento, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary:

$80-90k

Overview:

In this role, you will lead and mentor teams to manage document control and GMP training programs, ensuring regulatory compliance and inspection readiness, driving digital transformation, supporting cross-functional collaboration, and fostering a culture of continuous improvement and operational excellence within a fast-growing pharmaceutical and biotech organization.

Schedule:

Monday-Friday, standard working hours

Responsibilities:

• Lead and Develop Teams: Direct, mentor, and inspire the Document Control and GMP Training teams, fostering growth, accountability, and continuous improvement.
• Set Strategic Direction: Establish KPIs, objectives, and overall strategy for document control and training in alignment with organizational quality goals.
• Champion Regulatory Compliance: Ensure robust document management and training programs meet global regulatory requirements (21 CFR 210/211, EU GMP) and maintain inspection readiness.
• Oversee Document Lifecycle: Supervise the creation, organization, revision, archival, and retrieval of critical documents such as SOPs, Master Batch Records, and logbooks for multi-product/multi-site operations.
• Manage GMP Training Programs: Oversee employee training curricula, ensuring all staff are qualified, compliant, and prepared for evolving processes or regulatory changes.
• Drive Process Improvement: Proactively identify workflow bottlenecks, elevate document control best practices, and implement scalable solutions across the organization.
• Lead Digital Transformation: Act as the Business System Owner for electronic document and training management systems, overseeing system configuration, validation, and integrity per regulatory standards (21 CFR Part 11).
• Support Audits and Inspections: Represent quality systems during FDA/EMA audits, regulatory inspections, and customer visits, and deliver improvement strategies to leadership.
• Collaborate Cross-Functionally: Work closely with QA, Manufacturing, Regulatory, IT, and Engineering teams to drive seamless quality operations and support remediation efforts as needed.
• Uphold Culture and Standards: Set clear policies and productivity benchmarks, promote ethical practices, and cultivate a strong culture of operational excellence and compliance company wide.

Qualifications:

• Bachelor’s degree in Science, Engineering, or related field, Master’s degree strongly preferred.
• 8+ years of QA experience in a GMP-regulated environment.
• 3+ years of people management experience.
• Extensive knowledge of cGMP (21 CFR 210/211), EU GMP, GDP, 21 CFR Part 11, and ALCOA data integrity principles.
• Demonstrated expertise as a Business System Owner for digital Document Control/Training systems.
• Proven experience supporting successful regulatory inspections and customer audits.
• Superior project management, change leadership, and communication skills.