<h3>Job Description</h3>
Job DescriptionSalary: $90k - $110k 
About SpyGlass Pharma:
 
At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, We create for patients doesnt just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.
 
Summary:
The Clinical Research Associate (CRA) will be a key member of the Clinical Affairs team, responsible for supporting the planning, execution, and monitoring of clinical trials to ensure compliance with protocols, regulations, and company standards. This role requires strong attention to detail, excellent communication skills, and a proactive approach to clinical trial management.
 
Please note:This is a U.S. based, remote position that requires regular travel to clinical trial sites across the country (up to 70%). Applicants must be currently authorized to work in the United States and comfortable with a travel-based schedule.
Essential Duties and Responsibilities: 
<ul>
<li>Conduct site monitoring visits (initiation, routine, and close-out) to ensure compliance with the clinical protocol, GCP, and regulatory requirements.</li>
<li>Assist in the preparation and review of essential trial documents, such as informed consent forms, case report forms, and investigator brochures.</li>
<li>Collaborate with site staff to ensure proper documentation, timely data entry, and resolution of data queries.</li>
<li>Assist in the identification, selection, and training of investigative sites.</li>
<li>Maintain accurate and complete study files and records in accordance with GCP and company SOPs.</li>
<li>Monitor study progress to ensure timelines and quality standards are met.</li>
<li>Report site activities and findings to the Clinical Study Manager and escalate issues as necessary.</li>
<li>Support regulatory submissions by preparing clinical trial applications and maintaining relevant documentation.</li>
<li>Work collaboratively with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Project Management, to achieve study objectives. </li>
</ul>
 
Qualifications Required for Position: 
<ul>
<li>Bachelor's degree in life sciences, nursing, or a related field.</li>
<li>Minimum of 4 years of experience in clinical affairs within the pharmaceutical or medical device industry, with a preference on drug and drug/device combination products. </li>
<li>Knowledge of GCP, FDA/ICH guidelines, and clinical trial monitoring practices.</li>
<li>Strong organizational and problem-solving skills.</li>
<li>Excellent communication and interpersonal skills, with the ability to build strong relationships with investigative sites and internal teams.</li>
<li>Proficiency in Microsoft Office and electronic data capture (EDC) systems.</li>
<li>Ability to travel up to 50-75% domestically, as required.</li>
</ul>
 
Why SpyGlass Pharma?
<ul>
<li>We are offering a range of $90,000 - $110,000, based on experience and qualifications, along with an Annual Bonus opportunity.</li>
<li>Share in our success with stock options, giving you a stake in the companys future.</li>
<li>Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.</li>
<li>Generous paid time off, including holidays, vacation days, and personal leave.</li>
</ul>
SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. 

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to <a href="mailto:JOBS@SPYGLASSPHARMA.COM" target="_blank">JOBS@SPYGLASSPHARMA.COM</a> and let us know the nature of your request and your contact information.
 remote work

Senior Clinical Research Associate

<h3>Job Description</h3>
Job Description
WHY VITALIEF? Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape.&nbsp; By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients.​&nbsp; We are seeking a talented and enthusiastic Senior Clinical Research Financial Analyst to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’ mission to impact and save lives.&nbsp; Reasons to work for Vitalief:
<ul>
<li>You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better.</li>
<li>Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.</li>
<li>We give everyone a seat at the table – we encourage innovation.</li>
<li>Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.</li>
<li>Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.</li>
</ul>
Salary Range:&nbsp; $80,000 to $105,000 annually depending on experience level. Work Location: &nbsp;&nbsp;100% remote role; company location is New Brunswick, NJ.&nbsp; We are only seeking candidates that reside in the EST or CST zones. Job Responsibilities:
<ul>
<li>Reporting to the Manager, Budget &amp; Reimbursement, this financial analyst is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities. </li>
<li>Performs prospective reimbursement analysis according to CMS National Coverage Determination Decisions and all applicable billing regulations, third party requirements, industry standards, etc.</li>
<li>Works in conjunction with other departments of the firm, as well as representatives from other higher education institutions, sponsors, attorneys, governmental agencies, and principal investigators.</li>
<li>Requests clinical trial budgets and contracts documents from sponsors and CROs.</li>
<li>Reviews clinical trial protocols and develops internal budgets. Prepares clinical trial budget documents and memos. Determines whether each trial is a qualifying trial per CMS regulations, and assesses compliance with other regulatory requirements, including FDA and NIH guidelines.</li>
<li>Negotiates budgets with sponsors, interfacing with various internal departments as needed.</li>
<li>Facilitates clinical trial billing administrative start-up, insuring clinical research billing and regulatory compliance. Collaborate with Finance to coordinate documentation of each clinical trial account from the beginning of protocol submission to the end of the study utilizing OnCore CTMS system.</li>
<li>Performs regular audits of clinical trials to ensure that billing is complete and accurate and to ensure that the research project, database or protocol is carried out as outlined.</li>
<li>Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active clinical trials and research subjects.</li>
</ul>
Required Skills:
<ul>
<li>Bachelor’s Degree in Accounting, Finance, Business Administration or a related field.&nbsp; </li>
<li>3 to 5 years of experience in the maintenance and review of budgetary and fiscal records including experience with computer-based accounting systems in a healthcare environment.</li>
<li>Experience managing Clinical Trials budgets is required.</li>
<li>Maintains working knowledge of CMS, DHHS, FDA, OHRP, NIH, OIG, HIPAA and IRB. </li>
<li>Demonstrates excellent interpersonal, oral and written communication skills. Strong organizational and detail-oriented skills.</li>
<li>Proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, PowerPoint and OnCore. </li>
<li>Continuously displays “can do” attitude cross functionally to contribute to the overall customer service plan.</li>
<li>Develops professional relationships will all customers and maintains professional composure and confidence during stressful situations.</li>
</ul>
Preferred Skills:
<ul>
<li>Experience with clinical contracts, budget development, variance analysis and research of financial data and transactions. </li>
<li>Experience in clinical research administration; knowledge of regulatory, financial and administrative requirements of third-party billing for clinical trials and accounting principles for research preferred. </li>
<li>Experience or training in clinical research budgeting, financial management and/or coding.</li>
<li>Maintains thorough working knowledge of regulatory requirements and Good Clinical Practices (GCP). </li>
</ul>
PHYSICAL DEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs. #LI-DNP &nbsp;
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SNHTAcjcUx

Senior Financial Analyst, Clinical Trials

<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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Cwhub3GfJA

Senior Manager, Regulatory and Medical Writing - Remote

<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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GajSwYljsP

<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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dIadHrt2Ip

<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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upGWpipCjE

<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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202 Remote Clinical Trial Manager Jobs