medical monitor

Parexel

<div><div>Parexel is in the business of improving the world&rsquo;s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment &amp; Accountability.</div><div>
Parexel is looking for a Medical Director with a very strong background in Ophthalmology to join our Global Medical Sciences team. 
The role can be remotely based in any European country.
The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.
Primary activities will focus on Medical Monitoring Delivery &amp; PV Support. The medical monitor will independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician).
Medical Expertise and experience in Ophthalmology is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc.
Client Relationship Building &amp; Engagement, including soliciting and addressing client feedback and suggestions regarding medical study-related activities, are core skills required of the medical monitor.
Business Development: the medical monitor will provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings.
Skills<ul><li>
Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts</li><li>
Client-focused approach to work</li><li>
Excellent time management skills</li><li>
Excellent verbal and written medical communication skills</li><li>
Excellent standard of written and spoken English</li><li>
A flexible attitude with respect to work assignments and new learning</li><li>
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail</li><li>
Willingness to work in a matrix environment and to value the importance of teamwork.</li></ul>
Knowledge And Experience<ul><li>
Experience in clinical medicine (general or specialist qualifications) with Fellowship or specialty training in Ophthalmology, which is expected to be kept up to date.</li><li>
A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred</li><li>
Clinical practice experience</li><li>
Good knowledge of the drug development process including drug safety, preferred</li><li>
Experience in Pharmaceutical Medicine, preferred</li><li>
Experience leading, mentoring and managing individuals/ a team, preferred</li></ul>
Education<ul><li>
Experience as an Ophthalmology Physician in Industry or as a clinical trial investigator is required</li><li>
Previous CRO experience is strongly preferred</li><li>
Medically qualified in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship)</li></ul>
The ability to travel 15% domestically or internationally is required.</div> 
#LI-REMOTE</div>

Medical Director - Ophthalmology

TRIO - Translational Research in Oncology

<div>Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. 
 
TRIO is looking for a Clinical Research Physician to join our Medical Monitoring Unit team. Reporting to the Medical Monitoring Unit Manager, this will be a home-based, full-time position in the USA.
Main Responsibilities:<ul><li>
Act as Medical Monitor, performing comprehensive medical monitoring activities.</li><li>
Respond to medical inquiries from investigational sites and trial teams.</li><li>
Review patient eligibility and protocol deviations.</li><li>
Oversee patient safety by reviewing medical data at patient and trial levels.</li><li>
Review Serious Adverse Events (SAEs), including coding, causality and expectedness assessments, and drafting company comments.</li><li>
Prepares scientific slides, attends and/or presents protocol information at Investigator Meetings, Scientific Committee meetings, Safety Review Committee meetings, SIVs, etc.</li><li>
Serve as the primary clinical point of contact for scientific questions from internal and external stakeholders (e.g., IRBs, sites, sponsor medical teams, trial teams).</li><li>
Collaborates with the Medical Writing and Training Unit to write and/or review trial-specific medical documents (e.g., protocols, DSURs, CSRs).</li><li>
Conducting medical training on selected trial-specific or non-trial-specific topics.</li></ul>
Qualifications:<div><ul><li>
Medical Doctor degree required</li><li>
Excellent knowledge and understanding of oncology and oncology clinical trials</li><li>
At least 1 year of experience in medical monitoring in oncology trials</li><li>
Current knowledge of ICH GCP guidelines</li><li>
Advanced proficiency in MS Office in Word, Excel, and PowerPoint</li><li>
Strong teamwork abilities and communication skills</li><li>
Excellent level of English is required</li><li>
Spanish language knowledge will be valued</li><li>
Must be legally authorized to work in the country</li></ul></div>
What TRIO Can Offer You:
<ul><li>Competitive Salary</li><li>
3 weeks of vacation plus paid Christmas Closure</li><li>
2 weeks paid personal/sick time</li><li>
100% health benefits for you and your family paid by TRIO</li><li>
Flexible working hours</li><li>
Monthly internet allowance</li><li>
401K Program 5% Salary Contribution</li><li>
Home office allowance</li></ul>
Pay Range: $110,000 - $150,000. Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data. 
Prior to applying please review TRIO's Applicant Information Notice
To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI. 
 
To ensure fairness and an accurate understanding of your skills, we ask that candidates refrain from using AI tools or AI‑generated responses during interviews or assessments. We want the opportunity to get to know you and your experience.
Teamwork &middot; Passion &middot; Integrity &middot; Innovation
PcKtvbLyFN</div>

Clinical Research Physician

Eli Lilly

<div>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
Responsibilities<ul><li>
Provide medical oversight and strategic leadership throughout the clinical trial lifecycle, including the design, planning, execution, and interpretation of trials for investigational compounds, ensuring patient safety and scientific integrity.</li><li>
Contribute to the design and development of key clinical documents, including study protocols, investigator&rsquo;s brochures, informed consent documents, and other essential materials.</li><li>
Ensure the clinical development strategy adheres to industry best practices and regulatory guidelines while collaborating with study investigators and medical experts in the development and execution of study protocols.</li><li>
Lead the review and interpretation of clinical trial data, including safety assessments, efficacy endpoints, and overall trial progress.</li><li>
Serve as a key medical expert in cross-functional discussions, including regulatory submissions, investigator meetings, and advisory boards.</li><li>
Work with the Clinical Operations team to identify and resolve trial-related issues, ensuring smooth execution and compliance.</li><li>
Collaborate closely with the clinical operations, regulatory, and data management teams to ensure timely and high-quality execution of clinical trials.</li><li>
Collaborate with the research team to develop and implement a translational biomarker strategy for the program integrating early-phase data to inform clinical strategy.</li><li>
Contribute to regulatory submission efforts by providing clinical insight into IND submissions, clinical trial applications, and other regulatory documents support responses to health authorities and ethics committees.</li><li>
Represent the company at scientific conferences, advisory boards, and meetings with regulatory authorities.</li><li>
Develop and maintain relationships with external stakeholders, including key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs).</li><li>
Foster a collaborative and positive team environment that encourages innovation, scientific rigor, and high-performance standards.</li><li>
Travel to clinical sites, conferences, and regulatory meetings as needed.</li><li>
Other duties as assigned.</li></ul>
Basic Requirements<ul><li>
Medical Doctor must be board eligible or certified in a medical specialty relevant to the role or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.</li><li>
Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/professions/medical-physicians-and-osteopathic-physicians-home/medical-licensing-information/#Approved_Disapproved_Foreign_Medical_Schools</li></ul>
Additional Preferences<ul><li>
Clinical or research experience in cardiology or endocrinology</li><li>
At least 7 years of relevant experience.</li><li>
At least 2 years of experience overseeing the execution of clinical trials, preferably within an industry setting; ideal candidate might have experience with gene therapy/editing programs or early phase clinical development</li><li>
Strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices.</li><li>
Proven ability to interpret clinical trial data, experience serving as medical monitor on a clinical trial, including safety assessments and efficacy endpoints, and apply it to inform decision-making.</li><li>
Leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders.</li><li>
Excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings.</li><li>
Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs).</li><li>
Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus.</li><li>
Ability to travel to clinical sites, conferences, and regulatory meetings as needed.</li><li>
Collaborative mindset, fostering innovation, scientific rigor, and high performance in a team setting.</li><li>
Strong problem-solving skills with the ability to resolve trial-related issues and ensure smooth execution.</li></ul>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. 
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$240,000 - $352,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>

Sr. Director - Clinical Research Physician

<div>Join our dynamic Patient Safety team as a Senior Physician where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and post-marketing settings. In this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance.<h2 class="jobSectionHeader">
About the Role</h2>
As a Senior Physician in Patient Safety, you'll serve as the medical authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You'll collaborate with cross-functional teams, interact with clients, and contribute to the continuous improvement of our pharmacovigilance processes.
Key Accountabilities:
General<ul><li>
Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client&rsquo;s guidelines and procedures, and global drug safety regulations and guidelines</li><li>
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting</li><li>
Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee</li><li>
Interacting with internal and external stakeholders for resolving issues</li><li>
Attending and/ or presenting at client/cross functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs)</li><li>
Assisting the Project Lead/Functional Lead for audits and inspections</li><li>
Provides inputs for process improvements</li><li>
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process</li><li>
Function as pharmacovigilance representative/safety scientist</li><li>
Attend/support Bid defense meetings</li><li>
Actively mentoring Patient Safety Physicians to develop their skills and expertise</li></ul>
Case report medical review (as applicable)<ul><li>
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as require</li></ul><ul><li>
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality</li><li>
Review appropriateness of medical content in narrative for medical coherence</li><li>
Assessing seriousness, listedness / expectedness of reported events.</li><li>
Providing medical inputs to case processing team</li></ul><ul><li>
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)</li><li>
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative</li><li>
Identify and resolve case issues, coordinate with client therapeutic/legal team</li><li>
Provide guidance to junior physicians on case assessment methodologies</li></ul>
Periodic reports (as applicable)<ul><li>
Reviewing and/ or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs</li></ul><ul><li>
Providing medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluation reports (HHEs), etc.</li><li>
Clinical Expert Statements and other documents as required</li><li>
Review reports assessed by junior team members for accuracy and completeness</li></ul>
Medical monitoring (as applicable)<ul><li>
Answering day to day medical and scientific questions, provide daily medical support to Parexel staff or site (investigator/study coordinator), as needed</li><li>
Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities</li><li>
Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)</li><li>
Provide medical safety expertise to client per request</li><li>
Review and sign off Data Management line listings (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication, efficacy end points), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities</li><li>
Review and sign off technical documents written by Parexel with respect to medically relevant matters with particular attention to those relating to patient safety</li><li>
Review coding of adverse events, medical history and concomitant medications for accuracy and consistency</li><li>
Review of patient profile report as needed</li><li>
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors in conjunction with clients/sponsors or in conjunction with other Parexel departments</li><li>
Attend and present material as requested, at internal and external meetings (e.g., investigator meetings, therapeutic area training, Regulatory Authority meetings)</li></ul>
Literature review (as applicable)<ul><li>
Review of literature for product safety assessment and potential safety issues</li><li>
Expert in reviewing literature references including triaging, summarizing and providing MAH comments for aggregate reports and for various signal management activities</li></ul>
CSR Narratives (as applicable)<ul><li>
Performing medical review of Clinical study report narratives according to the client&rsquo;s guidelines and SOPs</li></ul>
Provide medical guidance to PV team/study team<ul><li>
Provide medical guidance to safety staff during the case processing cycle</li><li>
Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs)</li><li>
Provide medical input into Pharmacovigilance workflows and projects as required</li><li>
On an as-needed basis, provide support in mentoring or training of new hired physicians</li></ul>
Signal Detection and Management (as applicable)<ul><li>
Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities</li><li>
Perform signal validation activities</li><li>
Author/review SERs. Perform case analysis, review literature summaries, check draft for medical and scientific accuracy and cohesiveness</li><li>
Author/review responses to HA requests and other safety documents</li><li>
Providing oversight and relevant inputs to Medical Writers (MWs) authoring SERs, Signal validations etc.</li><li>
Managing safety signals on project specific tools (e.g., Signal Tracking System, Signal management tools, etc.)</li><li>
Contribution to Safety Management Team (SMT) meetings: Data analysis/ review, content creation, presentation/ facilitation, drafting of meeting minutes</li><li>
Training and mentoring junior team members on signal detection methodologies</li></ul>
Brand safety Physicians (as applicable)<ul><li>
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues</li><li>
Support the preparation and maintenance of Risk Management Plans</li><li>
Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs</li><li>
Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels and Development Core Safety Information (DSCI)</li><li>
Coordinate safety activities between Drug Safety Unit/team and internal and external partners</li><li>
Conduct/support signal detection and evaluation according to SOPs and guidelines</li><li>
Prepare safety assessments, SERs, as necessary, for potential signals or issues (product quality)</li><li>
Perform review and summarization of literature citations including epidemiology background research</li><li>
Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents</li><li>
Contribute to regulatory agency submissions (Investigational new drug applications, new drug applications, Marketing authorization applications, Variations and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages</li><li>
Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable</li></ul>
Therapeutic Area Expert (as applicable)<ul><li>
Serve as a subject matter expert within the designated Therapeutic Area, providing specialized knowledge to support drug safety initiatives and decision-making processes</li><li>
Collaborate with the TA Lead to implement strategic plans and enhance the overall expertise within the Therapeutic Area</li><li>
Contribute to the development and delivery of targeted training programs, elevating the knowledge base of fellow physicians and cross-functional teams</li><li>
Actively participate in internal and external scientific forums, representing Parexel's medical expertise through presentations, publications, and thought leadership activities</li><li>
Apply deep therapeutic knowledge to optimize pharmacovigilance processes, ensuring best practices are followed and continuously improved</li><li>
Mentor junior physicians within the TA, fostering their professional growth and encouraging their contributions to the field</li><li>
Support the TA Lead in identifying emerging trends and potential opportunities for innovation within the Therapeutic Area</li><li>
Engage in cross-functional projects, offering expert guidance to enhance the quality and efficiency of drug safety assessments</li></ul>
Skills:<ul><li>
Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date</li><li>
Demonstrated success in technical proficiency and scientific creativity</li><li>
Ability to work on complex tasks requiring in-depth evaluation</li><li>
Good knowledge of drug safety and the drug development process</li><li>
Ability to exercise judgment within broadly defined practices and policies</li><li>
Good presentation and verbal/written communication skills</li><li>
Good interpersonal skills</li><li>
Client focused approach to work</li><li>
Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps</li><li>
An ability to comprehend various regulatory or client requests and be able to strategize a handling approach</li><li>
Experience mentoring junior team members</li><li>
A flexible attitude with respect to work assignments and new learnings</li><li>
An ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail</li><li>
An ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential</li><li>
A willingness to work in a matrix environment and to value the importance of teamwork</li><li>
Strong knowledge of international drug regulation including ICH GCP, GVP, and all other applicable regulations and guidelines</li></ul>
Knowledge and Experience:<ul><li>
US Board Certification/board eligibility or regional equivalent for Canada</li><li>
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required.</li><li>
Previous CRO experience is highly desirable, but individuals with relevant experience as a Patient Safety/Drug Safety Physician within Industry will also be considered.</li><li>
Good knowledge/understanding of medical terminology</li><li>
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice</li></ul>
Education:<ul><li>
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School</li><li>
Completion of at least basic training in clinical medicine (residency, internship etc.)</li></ul>
This role offers the flexibility to work from home in either the US or Canada.
#LI-KS1 
#LI-REMOTE</div>

Senior Physician, Patient Safety (Senior Drug Safety Physician)

Vertex Pharmaceuticals

<div>Job Description
General Summary:
The Clinical Scientist Principal will provide scientific, clinical, and operational input to early and late stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will work on cross-functional study teams on design, execution, and monitoring of clinical trials, as well as data interpretation and communication. This role will also serve as a point of contact for investigators in day-to-day clinical study needs.
Key Duties and Responsibilities:
<ul><li>Works with cross-functional team with oversight by the Medical Lead to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities.
</li><li>Conducts medical monitoring reports, safety reviews, site interactions, and reviewing TFLs.
</li><li>Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead.
</li><li>Analyzes and synthesizes information to assess issues relating to protocol conduct and/or individual subject safety.
</li><li>Provides clinical operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
</li><li>Develops protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents with minimal direction from the Medical Lead.
</li><li>Collaborates with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.
</li><li>Represents Vertex to outside personnel in the development of clinical protocols and study conduct
</li><li>Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
</li><li>Leads literature reviews as needed.
</li><li>Prepares scientific material for conference presentations or publications.
</li></ul>Knowledge and Skills:
<ul><li>In-depth knowledge in analysis and interpretation of clinical data (safety and efficacy); proficient knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
</li><li>Ability to make independent, timely and appropriate decisions.
</li><li>Strong oral and written communication skills to explain difficult information and solid computer/analytical skills.
</li><li>Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
</li><li>High level of organizational and project management skills.
</li><li>Flexibility to accommodate changes in team and project needs.
</li><li>Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
</li></ul>Education and Experience:
<ul><li>Bachelor's degree in the Life sciences
</li><li>Typically requires 6 years of experience in clinical or pre-clinical research in the pharmaceutical industry or healthcare setting, or the equivalent combination of education and experience.
</li></ul>Pay Range:
$138,100 - $207,100
Disclosure Statement:
<div><div><div><div>The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
</div></div></div></div>Flex Designation:
Remote-Eligible
Flex Eligibility Status:
In this Remote-Eligible role, you can choose to be designated as:
 
1. Remote : work remotely five days per week and come into the office on occasion &ndash; you&rsquo;re always welcome on-site; or select
 
2. Hybrid : work remotely up to two days per week; or select
 
3. On-Site : work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex&rsquo;s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Remote
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com</div>

Clinical Scientist Principal

familyfriend home care

Administrative OfficerNursing Background PreferredArabic speakers PreferredResponsibilities:&middot; Prepare the schedule of the medical staff and the transportation.&middot; Arrange for staff distribution among patients.&middot; Handle any issue arise from the medical staff or the drivers.&middot; Handle the staff leave and reservation.&middot; Point of contact between the management and the home care staff.&middot; Prepare the documents required for the visa or renewal of license&middot; Handle issues arise from the patient side.Skills:&middot; Flexible and able to work under pressure.&middot; Respect and maintain confidentiality.&middot; Demonstrated leadership ability&middot; Available 24 hr. to handle emergency situation.Good knowledge of Microsoft application&middot; Good command of written and spoken English; knowledge of Arabic language is an advantage.&middot; Basic analytical, execution, problem solving and decision making skills.&middot; Handle logistic arrangement as but not limited to (medical waste collection, medical supplies, hospital appointment, uniform, staff documents collection, &hellip;)&middot; Prepare the staff attendance (DTR) and overtime, and forward it to the accountant.&middot; Maintain confidential records and files.&middot; Monitor Accreditation preparation.&middot; Monitor all administration department work process and follow up issues arise.&middot; To assist in the implementation of system and procedural changes resulting from new and revised policies and legislation.&middot; Monitor medical record &amp; entry in EMR (Doctor, Nurses and Physiotherapist)&middot; Manage staff and perform quality of work done by them.&middot; Assist the Nursing Supervisor in her work.&middot; Prepare reports as required by management.Job Type: Full-timePay: AED3,000.00 - AED4,000.00 per month

Administrative Officer

Ethics HR

Job Responsibilities:1. Procurement Operations: - Supervise day-to-day procurement activities for medical and non-medical items, ensuring timely and accurate purchase of goods and services. - Manage both direct procurement (medical equipment, clinical supplies, consumables) and indirect procurement (office supplies, utilities, services, maintenance, Projects) and Tendering and services contracts. - Develop, implement, and monitor procurement procedures aligned with company policies and regulatory and compliance standards. - Ensure purchase orders (POs), requisitions, and contracts are correctly documented and approved before issuance. - Maintain procurement records, including supplier catalogs, contracts, price lists, and purchase histories. 2. Supplier Management: - Identify, evaluate, and select suppliers for medical and non-medical items based on quality, cost, delivery, and compliance. - Build and maintain strong relationships with vendors, negotiating contracts, pricing, and terms to achieve cost savings and value-added benefits. - Monitor supplier performance, including delivery timelines, quality, and compliance with contractual obligations. - Ensure vendors meet legal, regulatory, and quality standards relevant to medical procurement. 3. Team Leadership &amp; Supervision: - Lead, coach, and supervise procurement staff, including junior buyers and procurement and Admin Teams. - Assign responsibilities, monitor performance, and ensure staff compliance with procurement policies. - Provide training and guidance on procurement processes, best practices, and compliance requirements. - Coordinate procurement activities with stakeholders and cross-functional departments to ensure timely completion and close all gaps. 4. Strategic Sourcing &amp; Cost Management: - Support the development of procurement strategies for both direct and indirect categories. - Identify opportunities for cost optimization, bulk purchases, and value engineering. - Conduct market research to benchmark prices, trends, and innovations in medical and nonmedical supplies. - Assist in budget preparation and monitor procurement expenditures against approved budgets. 5. Compliance &amp; Risk Management: - Ensure procurement processes comply with internal policies, regulatory requirements, and industry standards. - Maintain proper documentation for audits and internal/external compliance reviews. - Identify potential procurement risks and propose mitigation plans. 6. Reporting &amp; Communication: - Prepare and present regular procurement reports, including purchase summaries, vendor performance, savings, and forecasts. - Liaise with internal departments (Nursing, facilities, finance, operations) to understand requirements and ensure timely procurement. - Provide recommendations to management for procurement process improvements and strategic initiatives.Job Requirements:<ul><li>Bachelor&rsquo;s degree in Pharmacy, Business Administration, Supply Chain Management, or a related field from a reputable university.</li><li>Minimum 6 years of procurement experience, including experience in medical and non-medical</li></ul>fields.<ul><li>Healthcare Background is preferred.</li><li>Proven experience in direct and indirect procurement.</li><li>Strong knowledge of procurement regulations, contracts, and vendor management.</li><li>Familiarity with medical equipment, consumables, pharmaceuticals, and non-medical</li></ul>supplies.<ul><li>Proficiency in procurement software, ERP systems, and MS Office.</li><li>Strong leadership and team management skills.</li><li>Excellent negotiation, analytical, and problem-solving abilities.</li><li>High attention to detail and organizational skills.</li><li>Strong communication and interpersonal skills.</li><li>Ethical and compliance-oriented mindset.</li></ul>Job Type: Full-timeWork Location: In person

Procurement Supervisor

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