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<h3>Job Description</h3>
Job Description
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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in&nbsp;Global Health &amp; Pharma’s&nbsp;international awards programs for the last three consecutive years. For more information, visit <a href="http://www.mmsholdings.com" target="_blank">www.mmsholdings.com</a> or follow MMS on LinkedIn.
Responsibilities
<ul>
<li>Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias</li>
<li>Write and edit clinical development documents, mostly focusing on clinical protocols but the overall role may&nbsp;include, but is not limited to, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries,&nbsp;Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals</li>
<li>Complete writing assignments in a timely manner</li>
<li>Maintain timelines and workflow of writing assignments</li>
<li>Practice good internal and external customer service</li>
<li>Highly proficient with styles of writing for various regulatory documents</li>
<li>Expert proficiency with client templates and&nbsp;style guides</li>
<li>Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects</li>
<li>Contribute substantially to, or manages, production of interpretive guides</li>
<li>Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary</li>
<li>Mentor medical writers and other members of the project team who are involved in the writing process</li>
</ul>
Requirements
<ul>
<li>At least 3 years of previous experience in the pharmaceutical industry</li>
<li>Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience</li>
<li>The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline</li>
<li>Substantial clinical study protocol experience, as lead author, required</li>
<li>Experience leading and managing teams while authoring regulatory documents with aggressive timelines</li>
<li>Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus</li>
<li>Understanding of clinical data</li>
<li>Exceptional writing skills are a must</li>
<li>Excellent organizational skills and the ability to multi-task are essential prerequisites</li>
<li>Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools</li>
<li>Experience being a project lead, or managing a project team</li>
<li>Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus</li>
<li>Substantial clinical study protocol experience, as lead author, required</li>
<li>Experience leading and managing teams while authoring regulatory documents with aggressive timelines</li>
<li>Not required, but experience with orphan drug designations and PSP/PIPs a plus</li>
</ul>
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Senior Medical Writer (Protocols) - Remote

<h3>Job Description</h3>
Job DescriptionSalary: 
We are a global medical communications agency blending deep scientific expertise with creative brilliance to inspire change. Behaviour change starts with inspiration. By infusing vibrant creativity into our work, we produce engaging medical communications that have the power to captivate and spark action.
 Our absolute commitment to scientific precision across diverse therapy areas, including the complex fields of rare disease, oncology and advanced therapies, ensures we can make change a reality. For over 10 years, our team of exceptional PhD and advanced degree medical writers, strategists and world-class creatives have generated award-winning innovation across medical affairs and commercial disciplines. 
We are driven by a desire to create inspiring work that changes lives for the better, always guided by our core values; INTEGRITY, IMAGINATION, AGILITY, COLLABORATION and EMPOWERMENT that underpin who we are and the positive culture of our team. 
Part of Synaptiq Health, our network is made up of market access &amp; HEOR consultancy, Initiate and healthcare PR specialist, Beyond PR.
ROLE
 
Could you be our next Senior Medical Writer? In this role, youll work as content lead across a number of accounts and therapy areas. You will develop engaging and accurate copy for selected healthcare communications projects covering scientific communications, brand communications and patient communications. Youll also participate in proposals and pitches for your accounts and/or potential new clients in key therapy areas Joining this team offers a unique opportunity to contribute to the growth and development of our US presence. You'll be at the forefront of exciting projects, playing a pivotal role in shaping the future and helping expand our operations in this dynamic location. If you're eager to make an impact and be part of something transformative, this is the perfect chance to help build and influence the success of our Boston team. 
KEY RESPONSIBILITIES 
Independently develop and write engaging, accurate and fully referenced content for a wide variety of accounts and medical materials including print, digital applications, internal communications and meeting materials
Act as in-house therapy area expert, taking on the role of scientific lead on medium-sized account(s), with support from senior team members, where appropriate
Participate in the development and delivery of proposals for new business, including within your designated accounts 
Attend client and thought-leader meetings and teleconferences, leading on the content discussions as appropriate
Develop and maintain excellent relationships with all other departments, and collaboratively work with the design, development and accounts teams to produce high-quality communications
Manage personal workload and schedules, actively responding to fluctuating business workloads 
Actively contribute toward optimising ways of working within the medical team
Be a brand guardian, both for our own company brand as well as for our clients
Ensure all work allocated is executed within the timeline and schedule provided and to record all hours worked accurately 
Perform other duties as assigned 
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 
At least 3 years of experience working within a medical communications agency 
Educated to advanced degree or post-graduate level in life sciences or relevant area
Therapy area experience in immunology or oncology highly desirable 
Excellent attention to detail and ability to work simultaneously on more than one project
Good knowledge and understanding of current international life sciences arena
Ability to provide realistic ideas for projects which deliver on clients objectives
Experience across various channels of healthcare communications
Ability to write accurately and creatively in a fast-paced environment and to meet reasonable timelines
Adaptability and flexibility to changing priorities
Able to work as part of a team or solo
Excellent verbal and written communication
Ability to establish and maintain effective working relationships with co-workers, managers and clients
Sound judgement and decision making skills with ability to distinguish when further supervision is needed
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Strong software and computer skills, including MS Office applications 
OUR REWARDS 
Comprehensive medical, dental, and vision insurance plans (60% employer contribution)
Access to 401(k) investment options, with an employer matching contribution up to 4%
A range of paid time off benefits, including vacation leave, public holidays and sick leave.
 
We look forward to hearing from you!

Senior Medical Writer - Boston MA

<h3>Job Description</h3>
Job Description
The right words help people see more clearly. They can also influence, inspire, and change lives.&nbsp;
Are you the type of person who understands the power of words?&nbsp;
Do recent breakthroughs in mRNA, RNAi, and CRISPR spark your imagination?&nbsp;&nbsp;
As a&nbsp;Senior Medical Writer at CLD, you will&nbsp;combine your love of science, words, and writing skills to develop training materials for leading biotech, pharmaceutical, and medical companies. By helping our customers see more clearly, you&nbsp;will&nbsp;help them change patients'&nbsp;lives.&nbsp;&nbsp;
About CLD&nbsp;
Located in Belmont, MA, CLD (Custom Learning Designs) is a sales training agency that exclusively works with leading pharmaceutical, biotech, and medical device companies to ensure their commercial teams have the right knowledge at the right time to help them transform patients' lives.&nbsp;
Requirements
<ul>
<li>Understand a medical topic in depth and apply that knowledge to creating high-quality medical content</li>
<li>Research the primary literature to locate appropriate primary citations</li>
<li>Translate primary literature into accurate and compelling prose that is easily understood by a lay person</li>
<li>Demonstrate fastidious attention to detail</li>
<li>Display a high level of motivation and flexibility that allows you to work under deadline pressures and prioritize multiple tasks</li>
<li>Provide direction to internal staff for projects on which you serve as therapeutic content expert</li>
<li>Assist in proposal development and conduct client presentations and meetings</li>
<li>Some travel may be required</li>
</ul>
Qualifications
<ul>
<li>Advanced degree (MS or PhD) in life sciences or relevant experience</li>
<li>Minimum of 2 years medical writing experience in a pharma or biotech setting</li>
<li>Computer literacy</li>
</ul>
Company DescriptionCLD is a woman-owned business that designs and delivers customized training materials for pharmaceutical, biotech, diagnostic and medical device companies. Located just outside of Boston, the number one life sciences cluster in the country, our award winning team of in-house account managers, project managers, instructional designers, writers, graphic artists, illustrators and developers create the most innovative solutions across the entire training continuum. 
<h3>Company Description</h3>
CLD is a woman-owned business that designs and delivers customized training materials for pharmaceutical, biotech, diagnostic and medical device companies. Located just outside of Boston, the number one life sciences cluster in the country, our award winning team of in-house account managers, project managers, instructional designers, writers, graphic artists, illustrators and developers create the most innovative solutions across the entire training continuum.

Senior Medical Writer

<h3>Job Description</h3>
Job Description
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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in&nbsp;Global Health &amp; Pharma’s&nbsp;international awards programs for the last three consecutive years. For more information, visit <a href="http://www.mmsholdings.com" target="_blank">www.mmsholdings.com</a> or follow MMS on LinkedIn.
Responsibilities
<ul>
<li>Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias</li>
<li>Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries,&nbsp;Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals</li>
<li>Complete writing assignments in a timely manner</li>
<li>Maintain timelines and workflow of writing assignments</li>
<li>Practice good internal and external customer service</li>
<li>Highly proficient with styles of writing for various regulatory documents</li>
<li>Expert proficiency with client templates &amp; style guides</li>
<li>Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects</li>
<li>Contribute substantially to, or manages, production of interpretive guides</li>
<li>Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary</li>
<li>Mentor medical writers and other members of the project team who are involved in the writing process</li>
</ul>
Requirements
<ul>
<li>At least 3 years of previous experience in the pharmaceutical industry</li>
<li>Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience</li>
<li>The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline</li>
<li>Substantial clinical study protocol experience, as lead author, required</li>
<li>Experience leading and managing teams while authoring regulatory documents with aggressive timelines</li>
<li>Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus</li>
<li>Understanding of clinical data</li>
<li>Exceptional writing skills are a must</li>
<li>Excellent organizational skills and the ability to multi-task are essential prerequisites</li>
<li>Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools</li>
<li>Experience being a project lead, or managing a project team</li>
<li>Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus</li>
<li>Substantial clinical study protocol experience, as lead author, required</li>
<li>Experience leading and managing teams while authoring regulatory documents with aggressive timelines</li>
<li>Not required, but experience with orphan drug designations and PSP/PIPs a plus</li>
</ul>
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Senior Medical Writer (Remote)

<h3>Job Description</h3>
Job DescriptionSalary: Negotiable 
Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.
 
Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team.The medical writer will partner cross-functionallywith client teams inClinical Development, Clinical Operations,Biostatistics,Regulatory, and Program Management in planning and preparation of high-quality clinical and regulatory documents. The medical writer mayproduceprotocols, publications, study reports, investigator brochures,narratives,and module documents, according to clientand agency guidelines,to support drug development underbrisktimelines.
 
Initial contract length: 3 to 6 months, with potential for extension. 
Location:Fully remote,but must be able to attendkey (e.g.,roundtableor kickoff)meetings on site with clientsas requested.
 
Essential Duties &amp; Responsibilities
 
<ul>
<li>Manage execution of documents, including creating,maintaining, and communicatingtimelines</li>
<li>Coordinatecross-functionalclientcontributors and stakeholdersas well asinternal resources (e.g.,quality control [QC], publishing)</li>
<li>Serve as an expert on clientdocument management system and related tools, templates,and procedures to ensure efficient documentproduction</li>
<li>Leaddocument message developmentin collaboration with client</li>
<li>Plan and leadkickoffmeetingsandroundtable meetings for eachdocumentdraft; curate review comments to ensure efficient roundtable meetings; plan and lead roundtable meetings</li>
<li>Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents</li>
<li>Perform peerQC review as needed</li>
<li>Contribute to medical writing operationalinitiatives(e.g., templates, style guides, reference management)</li>
</ul>
Requirements
<ul>
<li>Experience (5+ years) as a medical writerin the CRO/biotech/pharmaceutical field, or equivalent</li>
<li>Bachelors degree in a relevant field</li>
<li>Oncology experience</li>
<li>Familiarity with the requirements for preparation of key clinical and regulatory documents, includingICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired</li>
<li>Expertise withMicrosoft Wordand other Microsoftapplications</li>
<li>Familiarity withdocument management systems</li>
<li>Ability to work both independently and collaboratively in the face of competing priorities</li>
<li>Service-oriented and proactive approach to project management</li>
<li>Excellentconflict management and negotiation skills</li>
<li>Strong written and verbal communication skills</li>
</ul>
 
Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
 
For further information or to apply, please reach out to <a href="mailto:careers@synterex.com" target="_blank">careers@synterex.com</a>. If anyone tries to contact you that does not come from a synterex.com email address or our HR system BambooHR, please delete and disregard the message as phishing scams are at an all-time high.

Senior Medical Writer (Contract)

<h3>Job Description</h3>
Job DescriptionFor more than 50 years, Washington County Mental Health Services (WCMHS) has served the Washington County community and the Orange County towns of Orange, Washington and Williamstown. WCMHS provides education, support, and treatment of individuals and families living with mental health challenges, substance use issues, and developmental and intellectual disabilities. Providing accessible, high-quality services in the community, schools, and health care settings, we work toward positive outcomes for wellness with collaborative, inclusive, and compassionate care. Washington County Mental Health Services is “Where Hope and Support Come Together.” Position:&nbsp; &nbsp;We are seeking a dedicated Employment Counselor to provide supported employment and modified case management services to individuals with intellectual disabilities and Autism Spectrum Disorder (ASD). Using person-centered planning and self-determination models, you will assist individuals in accessing, engaging, and maintaining successful careers and competitive employment. Key responsibilities include building relationships with businesses and training representatives to promote job placements, conducting interest and skill assessments, job carving, and job matching. You will also assist individuals in job searching, resume building, interviewing, and skills development, while offering follow-up services like employer check-ins, benefits counseling, and job accommodations. The Employment Counselor will develop individualized employment plans, provide job placement training, and offer full case management services for individuals not assigned a case manager. Additionally, you will collect data, track job placement outcomes, and prepare reports to meet state and agency requirements. Day-to-day supervision of employment specialists and coordination of employment services with case managers and community partners are also part of this role. The ideal candidate will stay current with industry trends, participate in team and employment meetings, design coaching approaches for staff, and contribute to marketing and instructional materials. If you’re passionate about supporting individuals in achieving meaningful employment and advancing their independence, we invite you to apply! Qualification:&nbsp;
<ul>
<li>BA preferred, combination of education and experience will be considered.&nbsp; </li>
<li>HS Diploma or equivalent required. </li>
<li>Candidates must have a clean driving record and access to a safe, insured vehicle as transportation of clients is possible.&nbsp; </li>
<li>Some work outside of the normal work schedule will be required such as evenings and weekends. </li>
<li>Access to reliable internet and phone service is essential. </li>
<li>Individuals with supported employment experience, and or experience in the business community are encouraged to apply.&nbsp; </li>
<li>Ability to lift and carry 50lbs. </li>
</ul>
Additional requirements for this position include:
<ul>
<li>Excellent written and verbal communications skills.</li>
<li>Strong organizational and time management skills</li>
<li>Creativity and excellent problem-solving skills</li>
<li>Ability to multi-task</li>
<li>Strong interpersonal skills with ability to elicit trust and listen effectively.</li>
<li>Ability to work with a diverse population of job seekers and staff.</li>
<li>Ability to maintain confidentiality and to understand personnel policies, e.g. workplace harassment, conflicts of interest. </li>
<li>Knowledge of issues confronting the employment of people with disabilities and other diverse and vulnerable populations.</li>
<li>Open, direct, honest, and clear communication style with ability to exercise discretion and tact.</li>
<li>Flexibility with openness to change (positive or negative) and to considerable variations in work environments.</li>
<li>Take initiative and work autonomously.</li>
<li>Ability to deal with conflict. </li>
<li>Proponent of continuous improvement and strategic thinking.</li>
<li>Values include holistic orientation, excellent customer service, strengths-based outlook and results oriented.</li>
<li>Ability to accept and deliver constructive feedback.</li>
<li>Availability and flexibility to work based on consumer and program needs and schedules.</li>
</ul>
Duties are performed in an office setting, local communities, job sites, individual’s homes where services are provided. Appropriate attire for the work environment is required. Ability to navigate these work locations is essential. Extended periods of sitting, standing, and walking may be required. Reliable transportation needed to perform essential functions of the position.&nbsp; Travel required for employer outreach, attend meetings and to respond to individual needs. Compensation and Benefits: This full-time position offers an hourly rate of $20.05/hr and excellent benefits, including tuition reimbursement/student loan assistance; generous paid time off; employer-sponsored health, dental, life, and disability insurances; and a 403(b)-retirement plan with employer match. To Apply: We encourage applicants to apply via the WCMHS website Careers page. Applications (resume and cover letter, preferred) may also be emailed to<a href="mailto:recruitment@wcmhs.org" target="_blank">recruitment@wcmhs.org</a>or mailed via USPS mail to WCMHS Human Resources, PO Box 647, Montpelier, VT 05601. Please note that only candidates selected for interviews will be contacted. WCMHS strives to make our application process accessible to all. If you need language assistance or an accommodation in the application process, please contact us at <a href="mailto:recruitment@wcmhs.org" target="_blank">recruitment@wcmhs.org</a> or 802-229-1399. Washington County Mental Health Services is an equal opportunity employer. Grounded in our understanding that diversity makes our organization stronger, we are committed to equity and inclusion in our workplace and services. We encourage&nbsp;applications from all qualified individuals and consider applications for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, health care coverage status, military status, age, disability, genetic information, citizenship status, or any other characteristic protected by federal, state, or local laws.&nbsp;
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Employment Counselor

<h3>Job Description</h3>
Job DescriptionRole Summary 
<ul>
<li>Responsibilities: You will be given hands-on experience working across Medical Communications, Evidence Development and/or Value and Access projects, all of which involve the assimilation, interpretation and creative presentation of scientific data related to pharmaceuticals or medical devices</li>
<li>Compensation: $24 to $30 per hour depending on experience</li>
<li>Benefits: Generous vacation leave allowance, flexible working hours and the chance to work from home 1 day per week, access to medical, dental and vision insurance, as well as funded social activities</li>
<li>Role Type: Full-time, 3-month internship</li>
<li>Start Date: We are currently recruiting for start dates in September and you will be asked to state your availability on your application form</li>
<li>Location: This role is available in our Boston office</li>
</ul>
About the Role
Our internships are ideal for current students and recent graduates in the sciences seeking to gain an insight into life at a fast-growing healthcare consultancy. We work with a wide range of clients, including the industry’s most successful pharmaceutical and medical technology companies, patient and public health organizations and non-profits. You will gain hands-on experience with a variety of projects, typically working on two to three projects for the duration of your internship. All projects involve the assimilation, interpretation and creative presentation of data from clinical trials, and depending on your team and project allocations, you could be working on anything from medical communications to market access and evidence synthesis. Specific tasks could include supporting the preparation of medical education slides, performing systematic searches of medical literature, developing clinical trial manuscripts, or assimilating clinical and cost-effectiveness evidence to support HTA submissions to NICE. These meaningful and exciting projects contribute to improving healthcare outcomes globally. Interns receive one-to-one training on the technical aspects of the role and learn about project management and effective communication with clients.
Analyst/Medical Writer Interns may be based in any of our scientific teams, and while you are here you would likely be working across projects for two different teams. Whether you are hired as an Analyst Intern or Medical Writer Intern will be determined by which team you are based in, though the responsibilities of the role are quite similar regardless of your team allocation. Generally, only applicants who will be working in Publications have the job title of Medical Writer Intern. These are broadly categorized as Medical Communications, Value and Access, Evidence Development, and Rare Diseases. If you have a particular interest in any of our services, please indicate this in your cover letter. Please note that, if successful, your team will be confirmed closer to your start date and, while every effort will be made to consider your team preference, this will be subject to business need and project availability.
Hybrid Working Policy: We recognize that home-working can improve work life balance, reduce commuting times and costs, and provide the opportunity to juggle personal commitments. At the same time, we believe that having face-to-face time in the office holds many benefits and is central to ensuring that the community we have created, where people have a workplace they belong to and feel part of, is never lost. Given the wealth of training, mentorship and development opportunities that are available as part of our internship programs, time spent in the office is even more crucial. Therefore, our Interns are able to work from home for 1 day per week. 
A Day in the Life of an Analyst/Medical Writer Intern
To learn more about a typical day for an Analyst/Medical Writer Intern at Costello Medical, please click here: <a href="https://www.costellomedical.com/day-in-the-life/scientific-intern.html" target="_blank">https://www.costellomedical.com/day-in-the-life/scientific-intern.html</a>
Career Prospects After the Internship
During the internship program, individuals performing well may be given the opportunity to extend their internship to six months (note that this is dependent on business need. When this happens, it allows our interns to further develop their skills and potentially gain experience of other areas of the company (again, dependent on business need as well as the individual’s interests). Additionally, there is the opportunity for strong candidates to apply for the Analyst/Medical Writer role and join our expanding team on a permanent basis. On average, 34% of our UK Analyst/Medical Writer Interns move into a permanent role with Costello Medical. We are hopeful that a similar percentage or more will progress into permanent roles in this new US internship program. To learn more about the benefits that we offer for permanent roles, please click here: <a href="https://www.costellomedical.com/careers/working-at-costello-medical/benefits-package-in-the-us/" target="_blank">https://www.costellomedical.com/careers/working-at-costello-medical/ben…</a>
To learn more about the personal and professional development we offer at Costello Medical, please click below to read firsthand accounts from our colleagues about their time with the company: <a href="https://www.costellomedical.com/careers/working-at-costello-medical/" target="_blank">https://www.costellomedical.com/careers/working-at-costello-medical/</a> 
Requirements
About You
This internship is suited to recent graduates and post-graduates, as well as current students who are permitted to complete full time internships either during the holidays or as a placement as a part of their degree. Please note that we do not recommend completing the Analyst/Medical Writer Internship program at the same time as studying, completing a dissertation or writing a PhD thesis due to the competing demands of your workload in your course and the role.
Essential requirements for the role are:
<ul>
<li> A degree or enrolled in a degree program in a scientific discipline (minimum or expected GPA 3.3). We welcome applications from candidates with a diverse range of educational backgrounds, but particularly those with coursework in the life sciences</li>
<li>Exceptional attention to detail</li>
<li>Strong analytical skills</li>
<li>Excellent written English and spoken English, and the ability to communicate scientific material clearly in both written and oral form for a variety of audiences</li>
<li>Strong organizational skills and the ability to plan your own work effectively, with a proactive approach to task prioritization and time management</li>
<li>The ability to communicate effectively and work collaboratively as part of a team</li>
<li>Strong self-motivation, self-awareness and willingness to learn, with a desire to contribute to the company above and beyond project work </li>
<li>Fluency in Microsoft Word, Excel and PowerPoint</li>
<li>A genuine interest in healthcare and an eagerness to learn about new areas of science</li>
</ul>
About Costello Medical
Costello Medical is a rapidly growing global healthcare agency specializing in medical communications, market access and health economic and outcomes research. We work with a wide range of clients, including the industry’s most successful pharmaceutical and medical technology companies, patient and public health bodies and charitable organizations. Our mission is to be a community of the very best people, building trusted partnerships across the healthcare sector by delivering an exceptional service. Our vision is to be a leading global partner consistently striving for meaningful and outstanding contributions that improve people’s health and lives.
On May 27th 2022 Costello Medical received its certification as a B Corporation. We are really proud of this achievement as it demonstrates that Costello Medical is meeting the highest standards of verified social and environmental performance. We underwent a rigorous assessment that covered the whole of our business including employee benefits, charitable giving and sustainability. We believe this certification is external validation of our mission to be a force for good.
The Recruitment Process
Our recruitment process includes a written assessment and proofreading exercise for you to complete in your own time. If successful, you will be invited to an interview with our members of our Analyst/Medical Writer recruitment team. Our standard recruitment process lasts around 1 month, however, this can be adapted if necessary.
As an equal opportunity employer, we are committed to fostering a diverse and inclusive workforce and, throughout the recruitment process, there are a number of reasonable adjustments we can provide. Please click here to read more about this and contact the People team via <a href="mailto:recruitment@costellomedical.com" target="_blank">recruitment@costellomedical.com</a> should you require reasonable adjustments at any stage.
We are currently recruiting for start dates in September and you will be asked to state your availability on your application form. 
While there are no set application deadlines, we strongly recommend applying as early as possible so that we can begin processing your application. The role will close when suitable candidates are found. 
Please note that this role is available in our Boston office, which you can learn more about here: <a href="http://www.costellomedical.com/careers/locations" target="_blank">www.costellomedical.com/careers/locations</a>
Benefits
What We Offer
We offer a competitive hourly rate of $24 to $30 per hour, depending on experience, and you will be entitled to pro-rated vacation days, based on internship length. We are proud to be a certified B Corporation company as this certification is a testament to the exceptional team at Costello Medical and their steadfast commitment to being a force for good. We are therefore eager to welcome individuals who share this vision. We provide exceptional internal training, opportunities to work on pro bono and charitable projects, and regular company-funded social activities.
How to Apply
You are required to submit your resume and a cover letter via our online application form. In your cover letter, you must explain why you think you would be suited to the role and why you would like to join Costello Medical, with examples to support both. Your resume should clearly state the dates of all qualifications and grades achieved where applicable.
While we embrace Artificial Intelligence (AI) technologies to innovate and improve processes, we want to understand your unique skills and experiences throughout the recruitment process. Therefore, if you use AI to assist with your application, we recommend that you do not rely solely on this technology to generate your application materials. As your role may involve developing new written content from scratch and handling confidential data that cannot be uploaded to AI technology, it is important for us to assess your own skills and abilities.
Please contact the Talent Acquisition team at <a href="mailto:recruitment@costellomedical.com" target="_blank">recruitment@costellomedical.com</a> if you have any questions about the role or application process.
Visa Sponsorship
We welcome applications from international candidates, but we are unfortunately unable to provide visa sponsorship for working visas. Therefore, you must have the right to work in the US independently from the company. However, we are able to consider those on a temporary visa, such as an OPT visa.

Analyst/Medical Writer Internship

<h3>Job Description</h3>
Job Description
POSITION SUMMARY: 
The Training Coordinator facilitates the agency’s training agendas. The ideal candidate is a self-starter, detail-oriented, team player, and possesses excellent communication and organizational skills with the ability to effectively work with staff, leadership team, interns, and other external stakeholders. The coordinator is responsible for managing employees’ onboarding and ongoing training, identifying training needs, developing curriculum, coordinating training initiatives with institutions, and evaluating the effectiveness of programs to ensure regulatory compliance and that employees acquire necessary skills and knowledge aligned with the agency’s goals. 
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
<ul>
<li>Develop and oversee the tracking of onboarding and ongoing training programs. </li>
<li>Coordinate and administer the training activities across programs: Home Care, Client Services and Community Engagement, Clinical Services, Special Programs, Protective Services, and Internship Program. </li>
<li>Manage the Training Administration Portal on Teams – training curriculum, training logs, CADER online training, and weekly training scheduling. </li>
<li>Oversee the Training Program Portal - update training contents, create training contents, and manage staff access. </li>
<li>Create, maintain, assess, and review individual performance measurements as aligned with regulatory requirements. </li>
<li>In collaboration with HR, coordinate periodic mandatory training, including the Learning Management System.</li>
<li>Oversee and coordinate the outsourcing training initiatives with Boston University CADER and other institutions as needed.
<ol>
<li>Request enrollment, review reports, ensure compliance, and maintain records. </li>
</ol>
</li>
<li>Work with the Internship Program’s leadership and administer interns training records such as training logs, contracts, evaluations, assignments, and schedules. </li>
<li>Coordinate the development, review, and revision of training materials for the staff and interns with the Care Management staff training requirements stipulated in ASAP RFR Section 9.1.6 and by current agency business practices and standards. </li>
<li>Participate in the development, review, and updating of CBES policies and procedures in collaboration with the CBES Program Operations Team, Directors, and Managers.</li>
<li>Stay abreast of federal, state, local, and other regulatory changes impacting ASAPs. </li>
<li>Provide training and shadowing for new staff and interns. </li>
<li>Identify and monitor retraining needs in collaboration with the Projects &amp; Quality team, Directors, and Managers and accordingly identify and address the training gaps. </li>
<li>Participate as a member of the Interdisciplinary Review Team.</li>
<li>Attend internal/external meetings as required.</li>
<li>Other projects and duties as assigned.</li>
</ul>
QUALIFICATIONS, EDUCATION, SKILLS, AND EXPERIENCE:
<ul>
<li>A bachelor’s degree is required, preferably in social work, human services, nursing, psychology, sociology, or a related field. </li>
<li>Licensed Independent Clinical Social Worker (LICSW), Licensed Certified Social Worker (LCSW), or Case Management Certificate preferred.</li>
<li>Three years of experience in human services, at least one year of Case Management, and supervisory experience strongly preferred.</li>
<li>Experience working in an Aging Services Access Point (ASAP) organization preferred. </li>
<li>Strong organizational, problem-solving, and attention to detail are required.</li>
<li>Excellent interpersonal, written, and verbal communication skills are required.</li>
<li>Ability to work with a diverse population and within a multi-disciplinary team.</li>
<li>Knowledge of Aging &amp; Independence, EOHHS, Medicare, and Medicaid regulations.</li>
<li>Become familiar with federal and state programs and local resources.</li>
<li>Strong computer skills, including Microsoft Office. </li>
</ul>
PHYSICAL REQUIREMENTS OF THE JOB: 
<ul>
<li>Ability to lift and carry objects weighing up to 10 to 15 pounds.</li>
<li>Ability to climb stairs.</li>
<li>Ability to travel to the community to perform visits at consumers’ homes.</li>
<li>Work requires regular standing, stooping, and bending.</li>
</ul>

Training Coordinator

<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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HrrZ5o3QSG

Senior Manager, Regulatory and Medical Writing - Remote

<h3>Job Description</h3>
Job Description
CAPS Collaborative is seeking dynamic Special Education teachers to join our dedicated team of professionals. This candidate will teach in alternative school classrooms designed to meet the needs of middle school students with emotional impairments and/or trauma history. Staff to student ratio of 8 students to 2 staff. 
The school classroom teams are supported by program administration, teachers, assistant teachers, behavioral staff, counselors, BCBA and nursing staff. We are looking to add energetic enthusiastic educators to our team. 
About us:
CAPS Collaborative will work in partnership with districts to provide programs and services of the highest quality. To provide these services, we adhere to the following values:
<ul>
<li>To commit every aspect of the organization to providing exceptional educational opportunities for students.</li>
<li>To demonstrate quality and responsiveness by becoming the first choice of districts for programs and services.</li>
<li>To be a customer-focused organization that constantly evaluates district needs.</li>
<li>To integrate quality, integrity, respect, and teamwork into every aspect of the organization.</li>
<li>To demonstrate accountability through constantly evaluating results and progress toward goals.</li>
<li>To implement programs and services in the most cost-effective manner and to exercise due diligence in financial decision making.</li>
<li>We will work in partnership with districts to ensure that students transition to the least restrictive environment in their home school district.</li>
</ul>
 
About the role:
To coordinate, develop, and execute developmentally appropriate individual learning programs and educational services that will contribute to students' academic, social, and emotional growth.
 
Responsibilities:
<ul>
<li>Performs a variety of assessments and observations to determine the areas in which the student may need extra or modified educational services.</li>
<li>Assessment areas may include academic performance, behavior, social development, or physical health.</li>
<li>Identifies the students' needs and develops related lesson and teaching plans.</li>
<li>Develops individualized education programs (IEPs) for each student, setting learning goals and adopting modifications as necessary; ensures each students activities and lessons are planned and organized according to his/her abilities.</li>
<li>Reports on student progress toward IEP goals quarterly.</li>
<li>Communicate effectively with students, staff, parents, and team members.</li>
<li>Develops and teaches lessons that provide engaging learning opportunities for small groups and individual students while meeting required specifications of IEPs and 504 plans.</li>
<li>Implements IEPs, provides ongoing or follow-up assessments, and continually tracks progress and makes modifications as necessary.</li>
<li>Understands and develops intervention strategies and behavior intervention plans.</li>
<li>Ensures programs comply with Individuals with Disabilities Education Act (IDEA); ensures each applicable student is provided with Free Appropriate Public Education (FAPE) that is properly modified for his/her individual needs.</li>
<li>Develops, completes, and maintains all paperwork mandated by local, state, and federal guidelines, laws, and regulations.</li>
<li>Attends all IEP meetings.</li>
<li>Maintains knowledge of special education teaching methods, research, and best practices through professional development and study.</li>
<li>Advocates on behalf of the students.</li>
<li>Celebrates the achievements and successes of students.</li>
<li>Recognizes the importance of staff attitude and professionalism in responding effectively to those in their charge.</li>
<li>Performs other related duties as assigned.</li>
</ul>
 
Candidate Requirements:
<ul>
<li>Excellent verbal and written communication skills.</li>
<li>Excellent interpersonal skills with ability to maintain a calm and patient demeanor with all students.</li>
<li>Thorough understanding of various special education needs and services.</li>
<li>Thorough understanding of and the ability to implement a variety of effective teaching methods.</li>
<li>Thorough understanding of policies, laws, and guidelines related to special education including IDEA, IEPs, and 504.</li>
<li>Excellent organizational skills and attention to detail.</li>
<li>Proficient with Microsoft Office Suite or related software.</li>
<li>Bachelors degree in Special Education required; Masters degree preferred.</li>
<li>Appropriate state license or certification required.</li>
<li>Two years of experience highly preferred.</li>
</ul>
 
Physical Requirements:
<ul>
<li>Prolonged periods standing and walking throughout school and classroom.</li>
<li>Must be able to lift to 15 pounds at a time.</li>
<li>Must be able to assist students who have physical difficulties.</li>
<li>Must be able to kneel, sit, stand, crawl, push, and pull to assist and teach children throughout the day.</li>
<li>Prolonged periods sitting and working on computer to complete necessary paperwork.</li>
</ul>

1,753 Education Full Time Jobs