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Harvard Divinity School invites applications for a one-year,term-limited, paid position for Yang Visiting Scholars in World Christianityfor the academic year 2024–25.
 Each visiting scholar teaches one course (either in the fall or inthe spring semester) and presents their research in a public lecture and/or other publicevents at HDS. Yang Visiting Scholars are required to be in full-time residence atHarvard Divinity School while carrying out their proposed research projects during theacademic year.
 Positions are open to early career or senior scholars withdoctorates in the fields of religion and to those with primary competence in other humanities,social science, and public policy fields who demonstrate a serious interest in WorldChristianity and hold appropriate degrees in those fields.
 Applications must be made online at <a href="https://academicpositions.harvard.edu/postings/12544" target="_blank">academicpositions.harvard.edu</a>.The deadline is September 30, 2023, for appointments beginning on August 1,2024.
 For more information, please visit our website at <a href="https://hds.harvard.edu/faculty-research/research-appointments/yang-visiting-scholars-world-christianity" target="_blank">hds.harvard.edu/yangscholars</a> or contact the Yang Scholars Program Office at <a href="mailto:yangscholars@hds.harvard.edu" target="_blank">yangscholars@hds.harvard.edu</a>.
HDS is an equal opportunity, affirmative-action employer, andencourages applications and nominations of women and/or ethnicminority candidates. All qualified applicants will receiveconsideration for employment without regard to race, color,religion, sex, sexual orientation, gender identity, nationalorigin, disability status, protected veteran status, pregnancy andpregnancy related conditions, or any other characteristic protectedby law.

Yang Visiting Scholars in World Christianity

Harvard University’s Faculty of Divinity seeks to make afull-time, tenure or tenure-track appointment in the area of Religion and Ecology tofill the Richard Reinhold Niebuhr Professorship of Divinity. Weseek candidates with expertise in Christian morality, ethics, and values, within the context ofglobal religious pluralism and diversity. We are particularly interested in ascholar with expertise either in environmental justice or environmental ethics. Thesuccessful candidate should be competent in the debates, methods, and theoreticalframeworks of the subfield of religion and ecology, including religion and climatechange. Applicants should also be familiar with forms of analysis that address race,gender, and social location. Excellence in teaching and research is expected. Thedoctoral degree must be held by June 30, 2024.
 The successful candidate will work closely with students in theDivinity School’s Master of Divinity, Master of Theological Studies, and Master ofReligion in Public Life programs, as well as PhD candidates in the Study ofReligion in the Graduate School of Arts and Sciences. They will also have anopportunity to teach undergraduates in Harvard College, and to collaborate withcolleagues and students in other related programs, departments, and schools in theUniversity.
Applications should be made online at:
<a href="https://academicpositions.harvard.edu/postings/12537" target="_blank">academicpositions.harvard.edu/postings/12537</a>
Applications must include a current CV, a cover letter, awriting sample, and three letters of recommendation (submitted by therecommenders through the application portal). Review of applications will beginon September 30, 2023, and continue until the position is filled.
 Letters of nomination are welcome. Applicants should address anyquestions regarding the position itself or the online application system tothe search office at <a href="mailto:niebuhrsearch@hds.harvard.edu" target="_blank">niebuhrsearch@hds.harvard.edu</a>.
 HDS is an equal opportunity, affirmative-action employer, andencourages applications and nominations of women and/or ethnicminority candidates. All qualified applicants will receiveconsideration for employment without regard to race, color,religion, sex, sexual orientation, gender identity, nationalorigin, disability status, protected veteran status, pregnancy andpregnancy related conditions, or any other characteristic protectedby law.

Tenured or Tenure-Track Position in Religion and Ecology

Harvard University’s Faculty of Divinity seeks to appoint afull-time tenured or tenure-track faculty member to fill the Charles Chauncey StillmanProfessorship of Roman Catholic Theological Studies. We welcome applications fromcandidates with expertise in Catholic theology, as well as those who studyCatholicism from the perspective of other disciplines—including Biblical studies,comparative studies, cultural studies, ethics, gender and sexuality, history,literature, philosophy, politics, and ethnography—and are open to the theologicaldimensions of their scholarship. Successful candidates should be prepared to teachclasses that reflect the cultural diversity of Roman Catholicism in the United Statesand around the world. Excellence in teaching and research is expected. Thedoctoral degree must be held by June 30, 2024.
 The successful candidate will work closely with students in theDivinity School’s Master of Divinity, Master of Theological Studies, and Master ofReligion in Public Life programs, as well as PhD candidates in the Study ofReligion in the Graduate School of Arts and Sciences. They will also have anopportunity to teach undergraduates in Harvard College and to collaborate withcolleagues and students in other departments and schools in the University.
 Applications should be made online at:
<a href="0000764481">academicpositions.harvard.edu/postings/12536</a>
Applications must include a CV, a cover letter, a writingsample, and the names and email addresses of three professional referenceswho are prepared to submit letters of recommendations. The School maycontact those persons directly at a later stage in the search. Review ofapplications will begin on September 30, 2023, and continue until the position is filled.
 Letters of nomination are welcome. Applicants should address anyquestions regarding the position itself or the online application system tothe search office. Please contact us at <a href="mailto:stillmansearch@hds.harvard.edu" target="_blank">stillmansearch@hds.harvard.edu</a>.
HDS is an equal opportunity, affirmative-action employer, andencourages applications and nominations of women and/or ethnicminority candidates. All qualified applicants will receiveconsideration for employment without regard to race, color,religion, sex, sexual orientation, gender identity, nationalorigin, disability status, protected veteran status, pregnancy andpregnancy related conditions, or any other characteristic protectedby law.

Stillman Professorship of Roman Catholic Theological Studies

Position Description: The Department of African and AfricanAmerican Studies seeks to appoint a tenure-track professor inAfro-Latin American Studies. Scholars working on the study ofpeople of African ancestry and on processes of racialstratification in Latin America, regardless of period, region, ordiscipline, are encouraged to apply. The appointment is expected tobegin on July 1, 2024. The tenure-track professor will beresponsible for teaching at the undergraduate and graduatelevels. Basic Qualifications: Doctoral degree required by the time theappointment begins. Additional Qualifications: Demonstrated strong commitment toteaching, research, and advising is desired. We are looking for acolleague who wants to work with us to the develop the field ofAfro-Latin American Studies. Special Instructions: Please submit the following materials throughthe ARIeS portal [LINK TO BE INSERTED] Applications must besubmitted no later than September 5, 2023 (with all referenceletters submitted by September 12, 2023). 1. Cover letter 2. Curriculum Vitae 3. Teaching/advising statement (describing teaching philosophy andpractices) 4. Research statement 5. Statement describing efforts to encourage diversity, inclusion,and belonging, including past, current, and anticipated futurecontributions in these areas. 6. Names and contact information of 3-5 referees, who will be askedby a system-generated email to upload a letter of recommendationonce the candidate's application has been submitted. Three lettersof recommendation are required, and the application is consideredcomplete only when at least three letters have been received. Atleast one letter must come from someone who has not served as thecandidate's undergraduate, graduate, or postdoctoral advisor. 7. Publications and as much of the dissertation and otherunpublished material as is relevant. The health of our workforce is a priority for Harvard University.With that in mind, we strongly encourage all employees to beup-to-date on CDC-recommended vaccines. Harvard is an equal opportunity employer and all qualifiedapplicants will receive consideration for employment without regardto race, color, sex, gender identity, sexual orientation, religion,creed, national origin, ancestry, age, protected veteran status,disability, genetic information, military service, pregnancy andpregnancy-related conditions, or other protected status. Contact Information: Alejandro de la Fuente, Chair of SearchCommittee, Department of African and African American Studies,Faculty of Arts and Sciences, Harvard University, Cambridge, MA02138 Contact Email: <a href="mailto:micconi@fas.harvard.edu" target="_blank">micconi@fas.harvard.edu</a>

TENURE-TRACK PROFESSOR IN AFRO-LATIN AMERICAN STUDIES

<h3>Job Description</h3>
Job Description
Food Manufacturing
Location : Peabody, MA
Position : Maintenance Mechanic
Salary: $27 to $34&nbsp;plus $2500 Stay-on-Bonus
Shift: 1st (Monday through Friday, 6:00 am to 2:30 pm, with flexibility for overtime and weekend coverage as needed)
Join a Growing Food Manufacturer as a Maintenance Mechanic
We’re seeking a skilled Maintenance Mechanic to join our team and keep our production equipment and facility systems running at peak performance. In this role, you’ll perform preventive maintenance, troubleshoot and repair mechanical/electrical issues, support general building maintenance, and ensure accurate documentation using our maintenance management system.
Ideal candidates have experience with mechanical and electrical systems, facility maintenance, and preventive maintenance programs in a manufacturing environment. Strong problem-solving skills, safety awareness, and flexibility to work overtime or weekends as needed are essential. Bilingual (Spanish/English) skills are a plus but not required.
Principal Duties and Responsibilities
<ul>
<li>Perform preventive maintenance, inspections, and corrective repairs on production machinery, including motors, conveyors, packaging systems, refrigeration support equipment, and auxiliary systems.</li>
<li>Troubleshoot and repair mechanical, electrical, hydraulic, and pneumatic issues using appropriate tools and diagnostic equipment (e.g., multimeters).</li>
<li>Conduct general facility maintenance, including lighting, plumbing, HVAC support, structural repairs, and other building needs.</li>
<li>Interpret and work from electrical schematics, blueprints, technical manuals, and work instructions to ensure accurate and safe maintenance tasks.</li>
<li>Respond promptly to equipment and facility-related breakdowns and emergencies, identifying root causes and implementing sustainable solutions.</li>
<li>Support and enhance preventive maintenance programs for both production and facility systems to minimize downtime and extend equipment life.</li>
<li>Safely operate material handling and support equipment (e.g., scissor lift, forklift, pallet jack) as needed.</li>
<li>Assist in after-hours building and equipment maintenance, including emergency response when required.</li>
<li>Collaborate with Production, Quality, and other departments to proactively identify and resolve maintenance issues.</li>
<li>Using the company's computerized maintenance management system (CMMS), maintain accurate records of maintenance activities, work orders, and parts inventory.</li>
<li>Ensure compliance with OSHA, USDA, SQF, and other applicable safety and regulatory requirements.</li>
<li>Perform other duties and special projects related to facility and equipment maintenance as assigned.</li>
</ul>
Requirements
<ul>
<li>High school diploma or GED required; technical school or maintenance certification preferred.</li>
<li>Minimum 2+ years of experience in industrial or facility maintenance.</li>
<li>Strong knowledge of mechanical and electrical systems, with experience troubleshooting production and building equipment.</li>
<li>Familiarity with hydraulics, pneumatics, plumbing, HVAC basics, and general building repairs.</li>
<li>Ability to read and interpret blueprints, schematics, and technical manuals.</li>
<li>Strong problem-solving and planning skills, with the ability to prioritize tasks in a fast-paced environment.</li>
<li>Basic computer skills for work order documentation and parts tracking.</li>
<li>Knowledge of OSHA safety standards and food industry compliance regulations (USDA, SQF).</li>
<li>Good oral and written communication skills.</li>
<li>Bilingual (Spanish/English) preferred but not required.</li>
<li>Flexibility to work overtime and weekends and adjust schedule as required to meet operational and facility needs.</li>
</ul>
Summary
The Maintenance Mechanic is responsible for ensuring optimal operation and reliability of production equipment and general facility systems. This role covers preventive and corrective maintenance on mechanical, electrical, hydraulic, and pneumatic equipment, as well as general building maintenance and support, to ensure a safe, efficient, and compliant food manufacturing environment.
Apply today to join a stable and growing team committed to operational excellence!
Company DescriptionGreenKiss Staffing Solutions, Inc. brings over 30 years of industry expertise to the forefront of nationwide recruiting. Our team of dedicated talent acquisition specialists delivers customized staffing solutions, including contract, contract-to-hire, on-site managed services, and direct professional placements. We specialize in sourcing top-tier talent for manufacturing and regulatory environments, ensuring each candidate aligns seamlessly with your organizational needs. At GreenKiss, we don’t just fill roles — we build strong, lasting partnerships by delivering the right people at the right time 
<h3>Company Description</h3>
GreenKiss Staffing Solutions, Inc. brings over 30 years of industry expertise to the forefront of nationwide recruiting. Our team of dedicated talent acquisition specialists delivers customized staffing solutions, including contract, contract-to-hire, on-site managed services, and direct professional placements. We specialize in sourcing top-tier talent for manufacturing and regulatory environments, ensuring each candidate aligns seamlessly with your organizational needs. At GreenKiss, we don’t just fill roles — we build strong, lasting partnerships by delivering the right people at the right time

Production Maintenance Mechanic - 1st Shift ($2500 Stay on Bonus)

<h3>Job Description</h3>
Job DescriptionAn Apprentice Optician is responsible for all facets of the dispensary while maintaining the highest level of customer service. Ensuring our patients have the best experience is a priority. A successful candidate will be self-motivated, organized and detail-oriented with an ability to multitask while working in a fast-paced environment. This position requires a commitment to teamwork and provides a great opportunity to join a growing and successful company. The Apprentice Optician will be expected to learn and support the policies and procedures necessary for opening, closing, and operating the dispensary.Responsibilities
<ul>
<li>Meet and/or exceed pre-established company goals for Sales, Collections, KPIs and Patient Experience expectations</li>
<li>Must perform all responsibilities as an Apprentice Optician</li>
<li>Listen and respond immediately with an appropriate level of concern to all patient and practice issues</li>
<li>Analyze, solve, and correct customer service issues</li>
<li>Ensure best practices are being delivered so that patients are satisfied and make their purchases with the optical dispensary</li>
<li>Communicate directly and promptly any concerns related to patient or practice satisfaction to their District Manager</li>
<li>Foster positive working relationships with the practice doctors, leadership and staff</li>
<li>You may from time to time be required to perform tasks not specifically listed here, but the company will ensure that you have received adequate training and support to facilitate such assigned tasks</li>
</ul>
Required Skills
<ul>
<li>Previous experience in retail and/or optical industry</li>
<li>State registration, licensure and certifications (where applicable)</li>
<li>Effective interpersonal skills</li>
<li>Excellent problem solving abilities</li>
<li>Strong communication skills (verbal &amp; written), including strong relationship building skills</li>
<li>Ability to adjust priorities and manage time wisely in a fast-paced environment</li>
<li>Ability to communicate in a clear concise and understandable manner</li>
</ul>

Apprentice Optician

<h3>Job Description</h3>
Job Description
Associated Home Care is hiring Caregivers!
Benefits:
<ul>
<li>Competitive&nbsp;pay,&nbsp;direct deposit,&nbsp;holiday pay,&nbsp;weekly pay.</li>
<li>Flexible scheduling - pick the shift that works best for your lifestyle</li>
<li>Weekday - Short shifts</li>
<li>Career advancement opportunities&nbsp;&nbsp;</li>
<li>Benefits (Medical, Dental, 401K)&nbsp;</li>
<li>Referral bonus -&nbsp;$$</li>
<li>Ongoing&nbsp;training and&nbsp;mentor&nbsp;program&nbsp;</li>
<li>Paid time off&nbsp;</li>
</ul>
Responsibilities:
<ul>
<li>
Assist clients with errands, light housekeeping, meal preparation, grocery shopping, transportation, ambulation, and transfers.&nbsp;
</li>
<li>
Personal care including dressing, bathing, mobility, incontinence care, and other services&nbsp;
</li>
<li>
Companionship and friendship for seniors and loved ones&nbsp;
</li>
<li>
Medication reminders&nbsp;
</li>
<li>
Communication in daily log of client's health, well-being, and activities&nbsp;&nbsp;
</li>
</ul>
Successful applicants will meet the following requirements:&nbsp;
<ul>
<li>Minimum High School Diploma or GED&nbsp;</li>
<li>Home Health Aide Certified&nbsp;</li>
<li>Valid driver's license, car&nbsp;insurance, and reliable vehicle&nbsp;</li>
<li>Open availability strongly preferred&nbsp;</li>
<li>Submit to criminal background check&nbsp;&nbsp;</li>
</ul>
Associated Caregivers possess that special something that makes them indispensable. They help our clients feel listened to and in control of their lives - whether by handling complex medical needs, preparing favorite meals, or simply taking a walk around the block. They intuitively know just what is needed. Just like family.&nbsp;
As a Caregiver on our team, you will provide one-on-one assistance to clients in the comfort of their own homes. In this role, you will provide exceptional in-home and companion experiences, fulfilling the personalized care plan of each client.&nbsp;
Associated is an independent, non-franchise company - our team is like family and we are looking for people who want to make a difference. We are strongly considering candidates with previous experience as a CNA, Homemaker, Personal Care Aide, Companion or similar positions.&nbsp; Our clients have a variety of needs and we are looking for people who have a passion for assisting older adults to live their most life fulfilled lives at home.&nbsp;&nbsp;
Make a difference in the life of a senior. Apply now!&nbsp;
AHC2000
HouseWorks, LLC and its Family of Companies is an Equal Opportunity Employer. We do not discriminate against race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.
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Caregiver - Home Health Aide (Short Shifts)

<h3>Job Description</h3>
Job Description
We are hiring a full-time and per diem Physical Therapist to join our dynamic care team at Southeast Rehabilitation &amp; Skilled Care Center in North Easton!
Working with our team and residents will give you purpose in your professional and personal life.
Here at Athena Health Care Systems, our employees are the heart of our organization, and we take immense pride in their dedication. We are not only committed to delivering high-quality care and customer service to our residents and their families, but we also aspire to be the employer of choice. We strive to create a workplace where your skills and talents are nurtured to allow you to grow within the com
As a Physical Therapist, you provide patient/resident assessment, care planning, direct treatment and consultation to a general rehab caseload while also participating in the clinical team process. You also provide teaching and training to caregiver staff and supervise other therapists, assistants, aides and students as required.
Education &amp; Experience:
<ul>
<li>
Bachelor of Science Degree, Master of Science or Doctoral degree in Physical Therapy.
</li>
<li>
Appropriate licensing requirements by individual states must be maintained.
</li>
<li>
Two (2) years of clinical experience preferred.
</li>
</ul>
Duties &amp; Responsibilities:
<ul>
<li>
Screens patients/residents.
</li>
<li>
Evaluates patients/residents and develops appropriate care plans.
</li>
<li>
May perform additional assigned administrative duties like: assigning and overseeing resident care activities, medical record oversight, assuring execution of physician orders, ordering supplies, etc.
</li>
<li>
Under a physician’s order, provides direct resident treatment in accordance with an established plan of care. Treatment venue includes individual, supervised and group.
</li>
<li>
Contributes to the team meeting and decision-making process as defined by the program.
</li>
<li>
Consults with and trains patients, residents and caregivers.
</li>
<li>
Monitors efficiencies on an ongoing basis in collaboration with supervisor.
</li>
<li>
Documents activities according to the company’s clinical documentation system on a timely basis.
</li>
<li>
Demonstrates consistent knowledge and application of Medicare and other reimbursement regulations.
</li>
<li>
Communicates effectively with patients, residents, team members, customer and supervisor.
</li>
<li>
Provides appropriate consultation to the facility.
</li>
<li>
Participates in clinical program development and implementation.
</li>
<li>
Participates in the training and orientation of other staff, students and volunteers.
</li>
<li>
Participates in the interview process for new staff.
</li>
<li>
Participates in census building and marketing activities.
</li>
<li>
Participates in quality improvement activities.
</li>
<li>
Responsible for service and operational excellence of all assigned activities to ensure the delivery of quality services and/or outcomes required to meet or exceed the expectations of those utilizing or impacted by the department.
</li>
<li>
Complies with facility Privacy Practices policies and procedures and protects residents’ individual health information.
</li>
<li>
Exhibits courtesy, compassion and respect to patients, residents, families, caregivers, visitors, physicians, administrators and co-workers.
</li>
</ul>
Specific Requirements:
<ul>
<li>
Ability to function effectively in multi-faceted systems and to interact effectively with all levels of staff and customers.
</li>
<li>
Strong oral and written communication skills.
</li>
<li>
Strong organizational and analytical skills.
</li>
<li>
Ability to perform documentation needs, manipulations of equipment and direct patient care.
</li>
<li>
Requires intense attention and concentration.
</li>
<li>
Ability to cope with periodic stress associated with changing census and staffing demands.
</li>
<li>
Demonstrated ability to prioritize and manage time effectively for self and others.
</li>
<li>
Ability to deal with a wide range of personality types, ages, and diverse cultural backgrounds.
</li>
<li>
Ability to articulate and comprehend the English language.
</li>
<li>
Standing and walking for significant amounts of time is necessary.
</li>
</ul>
About Athena Health Care Systems:
Since its establishment in 1984, Athena Health Care Systems has pioneered the delivery of exceptional healthcare services. Operating nursing homes and hospice agencies across Connecticut, Massachusetts, and Rhode Island, Athena stands out as a healthcare leader in Southern New England.
Athena’s Benefits:
<ul>
<li>
Competitive and Weekly Pay
</li>
<li>
Holiday Pay for Hourly and Salaried Employees
</li>
<li>
Overtime Pay for Hourly Employees
</li>
<li>
Career Advancement Opportunities
</li>
<li>
Exclusive Employer Discount Program
</li>
</ul>
Available for Eligible Team Members:
<ul>
<li>
Employer-Paid Life Insurance
</li>
<li>
401(k) with Employer Match
</li>
<li>
Vacation and Personal Time
</li>
<li>
Health, Dental, and Vision Insurance
</li>
</ul>
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. Athena Health Care Systems and its managed facilities/agencies follow federal and state mandatory guidelines regarding staff vaccinations; our vaccination policy requires all newly hired staff, regardless of position or work location, to be fully vaccinated against COVID-19 unless they receive an approved exemption from Athena, except where prohibited by state law.

Physical Therapist

<h3>Job Description</h3>
Job Description
Join a Collaborative Team and Thrive in a Growing Practice
InCare Pulmonary &amp; Sleep Specialists is seeking a Board-Certified/Board-Eligible Pulmonary Physician to join our expanding team in North Andover, MA. This is an excellent opportunity to work in a supportive, patient-focused environment with a strong clinical team and administrative infrastructure.
About the Role
<ul>
<li>
Primary Location: North Andover clinic
</li>
<li>
Team Structure: We currently have one physician with 4 Advanced Practice Providers with full patient panels, supported by medical assistants and reception/office management staff
</li>
<li>
Schedule:
<ul>
<li>
Clinic: Monday–Friday, 8:00 AM – 5:00 PM
</li>
<li>
Average 16–20 patients/day, with flexible appointment types (new &amp; follow-up)
</li>
</ul>
</li>
<li>
Critical Care Option:
<ul>
<li>
1 week/month at partner hospitals (Holy Family &amp; Lawrence General, both within 15 minutes of the clinic)
</li>
</ul>
</li>
<li>
Weekend Call: 1 weekend/month (Saturday &amp; Sunday) covering both hospitals, rounding on 10–15 patients; timing is flexible
</li>
<li>
Additional Options: Sleep medicine can be incorporated if desired
</li>
<li>
EMR: eCW (clinic) and Meditech (hospital)
</li>
</ul>
Compensation &amp; Benefits
We offer a competitive, guaranteed salary plus wRVU productivity bonus, with packages tailored to candidate experience and interest:
<ul>
<li>
Pulmonary Only: Starting at $300,000
</li>
<li>
Pulmonary/Critical Care: Starting at $365,000
</li>
<li>
wRVU production incentive based on base salary
</li>
<li>
Comprehensive Benefits: Health, dental, vision, life insurance, long-term disability
</li>
<li>
Retirement Plan: 401(k) with employer contribution
</li>
<li>
Paid Time Off
</li>
<li>
CME Allowance
</li>
<li>
Malpractice Coverage provided
</li>
</ul>
Why Join Us
<ul>
<li>
Collaborative team environment with strong APP support
</li>
<li>
Dedicated office space and exam rooms for each physician
</li>
<li>
Ongoing investment in workflow support, including consideration for scribes
</li>
<li>
Opportunity to participate in hospital care, teaching, and sleep medicine (if desired)
</li>
<li>
Leadership that values physician input and work-life balance
</li>
</ul>
Ready to take the next step? Join a practice committed to providing high-quality, patient-centered pulmonary care while supporting your professional growth.
*InCare Pulmonary and Sleep Specialists is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to providing an inclusive environment for all employees, free from discrimination and harassment.

Pulmonary Physician Opportunity - North Andover, MA

<h3>Job Description</h3>
Job Description
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit <a href="http://www.azurity.com" target="_blank">www.azurity.com</a>.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief team/department description:
As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities. The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.
Principle Responsibilities:
<ul>
<li>Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements</li>
<li>Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies</li>
<li>Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input</li>
<li>Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy</li>
<li>Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics</li>
<li>Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings</li>
<li>Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports</li>
</ul>
CORE Responsibilities
<ul>
<li>Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections</li>
<li>Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies</li>
<li>Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&amp;D pipeline</li>
<li>Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions</li>
<li>Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests</li>
<li>Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions</li>
<li>Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling</li>
<li>Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input</li>
<li>Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths</li>
</ul>
Qualifications and Education Requirements
<ul>
<li>10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background</li>
<li>Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs</li>
<li>Experience leading teams, coaching, and fostering a culture of efficiency and teamwork</li>
<li>Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met</li>
<li>Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely</li>
<li>Bachelor's degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)</li>
</ul>
#LI-Hybrid
Physical &amp; Mental Requirements:
The physical 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.
<ul>
<li>Must be able to sit for long periods of time</li>
<li>While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear</li>
<li>May occasionally climb stairs and/or ride elevators</li>
<li>The employee must occasionally lift and/or move up to 25 pounds</li>
<li>Employee must be able to manipulate keyboard, operate a telephone and hand-held devices</li>
<li>Other miscellaneous job duties as required</li>
</ul>
Benefits We Offer:
<ul>
<li>Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
<ul>
<li>Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.</li>
<li>Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you. </li>
</ul>
</li>
<li>Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.</li>
<li>Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*</li>
<li>Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.</li>
<li>Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.</li>
<li>Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.</li>
<li>Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.</li>
<li>Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.</li>
<li>Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.</li>
</ul>
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