field_job_employment_type

field_job_occupational_field_parents_all

job_organization_name

city

state

<h3>Job Description</h3>
Job Description
Center Based Teacher - Infant/Toddler
 
Triumph supports the education, well-being and self-sufficiency of young children and their families through high quality early childhood programs and community engagement.
 
As a Center based teacher, you will be responsible for facilitating and guiding activities for a preschool classroom, including curriculum implementation, daily classroom activities, and selecting and arranging equipment and materials in the classroom including maintaining a safe, neat, organized learning environment that is welcoming, nurturing, and high functioning.
Responsibilities:
<ul>
<li>Assisting with the implementation of developmentally appropriate activities for children</li>
<li>Communicating with families about their children's development and progress</li>
<li>Guide and facilitate activities of the children, including curriculum implementation, daily activities, field trips, selecting and arranging equipment and materials in the classroom.</li>
<li>Complete and submit required forms and records in a timely and accurate fashion.</li>
<li>Participate in pre-service training, in-service training, and other mandatory training requirements to meet EEC and Head Start requirements.</li>
</ul>
Requirements:
<ul>
<li>Minimum CDA (Child Development Associate) credential</li>
<li>Massachusetts EEC Teacher Infant/Toddler certified. (Agency offers certification if not obtained independently) </li>
<li>Knowledge and experience of developmentally appropriate practices with 1-2 years’ minimum experience working with infant/toddler children.</li>
<li>Must have effective interpersonal and communication skills.</li>
</ul>
Benefits &amp; Compensation
Salary range between $19.28 - $28.88/hr. dependent on education and experience
Medical, Dental &amp; Vision; Life Insurance; Short/Long term disability; 403B retirement plan with 5% agency match; 13 paid holidays per year; Paid personal, vacation, and sick time
Monday-Friday; 32.5 hours per week; 52 weeks per year
Must be available to work shift of 8:00 am and 3:00 pm
 
English speaking with Spanish, Portuguese or Haitian-Creole bilingual applicants encouraged to apply
 
If you are passionate about working with young children and families and meet the requirements for this position, we encourage you to apply today!
 
Thank you for considering this opportunity to make a difference in our community through high-quality early childhood programs. We look forward to hearing from you!

Center Base Teacher - Infant/Toddler **NEW SALARY RATE**

<h3>Job Description</h3>
Job DescriptionSalary: Negotiable 
Synterex, Inc. is a global 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 senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.
Location: Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested.
Essential Duties &amp; Responsibilities
<ul>
<li>Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines</li>
<li>Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documents</li>
<li>Ensure document development adheres to any relevant client processes, templates, and instructional documents</li>
<li>Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document development</li>
<li>Lead document message development in collaboration with client</li>
<li>Interpret data and create shell documents to support authoring</li>
<li>Plan and lead kickoff meetings</li>
<li>Facilitate resolution of review feedback including planning and leading comment resolution meetings (curate review comments to ensure meetings are efficient)</li>
<li>Follow-up with individual team members as needed to resolve outstanding review feedback</li>
<li>Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents</li>
<li>Conduct literature searches as needed</li>
<li>Perform peer QC review as needed</li>
</ul>
<ul>
<li>Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed</li>
</ul>
Requirements
<ul>
<li>Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field</li>
<li>Bachelors degree or higher in a relevant field</li>
<li>Oncology, Infectious Disease, or Vaccine experience desired</li>
<li>Experience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents</li>
<li>Flexibility to work across multiple therapeutic areas, if needed</li>
<li>Experience writing documents according to established processes and document templates</li>
<li>Familiarity with lean authoring approaches and structured content management</li>
<li>Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired</li>
<li>Expertise with Microsoft Word and other Microsoft applications</li>
<li>Experience developing documents using document management systems, collaborative authoring tools, and review tools</li>
<li>Comfortable adapting to new tools and technologies, if needed</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>Excellent conflict management and negotiation skills</li>
<li>Comfortable providing suggestions based on previous experience</li>
<li>Strong written and verbal communication skills</li>
</ul>
For further information or to apply, please reach out to <a href="mailto:careers@synterex.com" target="_blank">careers@synterex.com</a>.
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.
Synterex participates in the Department of Defenses SkillBridge program. For more information, please visit <a href="http://www.synterex.com/fellowships-internships" target="_blank">www.synterex.com/fellowships-internships</a>.

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, 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>
Powered by JazzHR
EQz0mM9NwI

Senior Medical Writer (Remote)

<h3>Job Description</h3>
Job DescriptionBusiness Analyst I – Agile PLM Training Coordinator
Location: Fully Remote (HQ in North Reading, MA 01864) Pay Rate: $25–$35/hour (W2) depending on experience Contract Length: 12 Months (Full-Time, W2 Contract) Start Date: ASAP Schedule: Monday–Friday, Core Business Hours (Up to 10 hrs/week overtime possible)
Russell Tobin is partnering with a leading global e-commerce and robotics technology powerhouse to bring on a Business Analyst I focused on Agile PLM training and adoption. This opportunity is part of a growing operations team that plays a key role in how hardware and robotics products scale across the organization.
The Role
As the Agile PLM Training Coordinator, you will design, develop, and lead training programs to support internal users of the Agile Product Lifecycle Management (PLM) system. You’ll collaborate with subject matter experts, drive user adoption through hands-on learning experiences, and support the team with documentation and system guidance.
Responsibilities
<ul>
<li>
Develop Training Content: Create user-friendly guides, visual decks, quick reference tools, and scenario-based exercises.
</li>
<li>
Deliver &amp; Coordinate: Host training sessions (live virtual, in-person if needed, and asynchronous) across multiple teams.
</li>
<li>
Maintain Curriculum: Ensure materials stay up-to-date with Agile PLM changes and reflect current business needs.
</li>
<li>
Provide User Support: Act as a knowledge hub for Agile PLM-related questions and user troubleshooting.
</li>
<li>
Drive Process Improvement: Monitor feedback, evaluate training success, and suggest enhancements.
</li>
</ul>
What You'll Gain
<ul>
<li>
Hands-on experience with a world-class robotics operations group
</li>
<li>
Direct involvement with high-impact projects in a globally recognized tech environment
</li>
<li>
A chance to get your foot in the door at one of the most admired companies in tech
</li>
<li>
A supportive and diverse team that values growth and initiative
</li>
</ul>
Basic Qualifications
<ul>
<li>
Bachelor’s degree in Education, Business, Engineering, or a related field
</li>
<li>
3+ years of experience delivering and developing training programs (preferably within a PLM system like Agile)
</li>
<li>
Strong grasp of Agile PLM functions: Change Management, BOM, Document Management, and Workflow
</li>
<li>
Proficiency in Microsoft Office Suite
</li>
<li>
Excellent communication, presentation, and planning skills
</li>
</ul>
Preferred Qualifications
<ul>
<li>
Experience with Agile PLM administration
</li>
<li>
Familiarity with e-learning tools (e.g., Storyline, Captivate) and Learning Management Systems
</li>
<li>
Certifications in training and development
</li>
</ul>
Top 3 Must-Have Skills
<ol>
<li>
Agile PLM experience
</li>
<li>
Technical writing &amp; training documentation
</li>
<li>
Change management knowledge
</li>
</ol>
Leadership Traits
<ul>
<li>
Bias for Action – Take initiative, move fast, and make things happen
</li>
<li>
Dive Deep – Investigate root causes and make data-informed decisions
</li>
</ul>
Ready to empower a next-generation operations team? Apply now and let’s talk about how you can play a pivotal role in training and enablement at one of the most innovative companies shaping the future of commerce and robotics. 
Benefits InfoPride Global offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life &amp; disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors. #LI-BK1

Agile PLM Training Coordinator

<h3>Job Description</h3>
Job DescriptionA Career Program Specialist (Admissions Representative) assists prospective students examine personal interests and styles and provide guidance to reach their career goals.
The Career Program Specialist will …
<ul>
<li>Follow-up with qualified prospective students based on online applications and inquiries.</li>
<li>Accurately and compliantly communicate the campus features and program information to prospective students.</li>
<li>Conduct follow-up for prospective students to assure completion of paperwork and essential documents for enrollment requirements, and that they are prepared to start school.</li>
<li>Ensure the student works with the financial aid department, completing all required paperwork on a timely basis. </li>
<li>Generate regular referrals.</li>
<li>Participate in the public relations activities and recruiting events.</li>
<li>Maintain support for enrolled students to enhance student graduation, employment, and referrals.</li>
<li>Support high school activities including scheduling appointments, giving presentations, and inquiry follow up.</li>
</ul>
Position Requirements:
<ul>
<li>High school diploma/GED required; Associates degree preferred.</li>
<li>2 years of sales or customer service experience required.</li>
<li>Knowledge of career education helpful</li>
<li>Ability to pass background check as required by local high school</li>
<li>Excellent communication, public relations and promotional skills</li>
<li>Computer skills and the ability to use common software programs (Word, Excel, PowerPoint, etc.)</li>
</ul>
About our company:
Porter and Chester Institute, a leading trade school in Connecticut and Massachusetts for 75 years, adheres to one basic vision: to educate and train our students to the level that will make them competent employees. With 7 campus locations throughout Connecticut and Massachusetts, we offer training in such trades as Automotive Technology, HVAC-R, CAD, Electrician, Plumbing, as well as Medical Assisting, Dental Assisting, Practical Nursing and Computer &amp; Technology.
Our support staff, including Admissions, Financial Aid and other administrative professionals, to our highly qualified Instructors are focused on making the students' experience a fulfilling and enriching one, both professionally and personally.
Click here for more company information: <a href="https://porterchester.edu/about-pci" target="_blank">https://porterchester.edu/about-pci</a>
We are an Equal Opportunity Employer.
 Position Hours: Mon, Wed, Fri 8:30a-5p; Tues, Thurs 10:00a-7p; Saturdays as needed

Admissions Representative

<h3>Job Description</h3>
Job DescriptionSalary: 
Synterex, Inc. is a global 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 Manager, Medical Writing will report to the Executive Director of Medical Writing and Quality Assurance and will be responsible for the coordination, management, and growth of Medical Writing team members and vendors/contractors. The Manager, Medical Writing will partner cross-functionallywith client teams inClinical Development, Clinical Operations, Biostatistics,Regulatory, and Program Management, in planning, preparing, oversight, and/or review of high-quality clinical and regulatory documents (protocols, study reports, sections of marketing applications in CTD format, etc.).
This is a full-time position.
 
Location:Hybrid; must be able to attend occasional client meetings on site as needed
 
Essential Duties &amp; Responsibilities
<ul>
<li>Manage direct reports, coordinate resources, and develop work plans that align with internal and external goals and timelines</li>
<li>Oversee quality output of deliverables delegated to Medical Writing personnel and vendors/contractors</li>
<li>Ensure that all clinical regulatory documents:</li>
</ul>
<ul>
<li>Comply with international, national, and pertinent local regulations</li>
<li>Adhere to SOPs and guidance documents (internal and/or external)</li>
<li>Are completed according to timelines</li>
</ul>
<ul>
<li>Liaise with Executive Leadership team to report on and optimize staff utilization and other key performance indicators (KPIs); record and utilize metrics to inform KPIs</li>
<li>Support Medical Writing and Business Development leadership in preparation of work orders, budgets, invoicing, and forecasting</li>
</ul>
<ul>
<li>Coordinate with Business Operations to answer customer inquiries and enhance time reporting processes</li>
<li>Provide guidance and leadership for document development for regulatory writing deliverables, including organization, content, and resource requirements</li>
<li>Ensure quality and consistency of style, format, and content for all documents</li>
<li>May assist in the planning, writing, and assembly of clinical protocols and amendments, clinical study reports, summaries of safety/efficacy, other regulatory documents (annual reports, briefing documents), safety reports, patient narratives, and investigator brochures/updates as needed</li>
</ul>
Requirements
<ul>
<li>Undergraduate degree in a scientific or health-related field required</li>
<li>Minimum 3 years of clinical research/drug development experience in biotech, pharmaceutical, or contract research organization (oncology experience a plus). Equivalent experience in a related medical field is acceptable.</li>
<li>Experience managing diverse teams preferred</li>
<li>Team-oriented, self-motivated, assertive, self-confident, and capable of working under minimal supervision</li>
</ul>
<ul>
<li>Ability to assess and coordinate resources and work effectively across multi-disciplinary work teams</li>
<li>Exceptional communication and interpersonal skills</li>
<li>Excellent organizational and project management skills to coordinate resourcing across multiple projects</li>
<li>Experience with regulatory documents (Module 2 summaries, IND, MAA, annual reports, ISE &amp; ISS); writing nonclinical reports and tabulated summaries a plus</li>
<li>Proficient with Microsoft Word, Excel, Project, and PowerPoint</li>
</ul>
<ul>
<li>Working knowledge of GCP, 21 CFR, CTD, ICH guidelines/regulations, and the drug development process is required</li>
</ul>
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.
 
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.

Manager, Medical Writing

<h3>Job Description</h3>
Job Description
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency,&nbsp;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, 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>Bachelor’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field is required with at least 6 years of previous regulatory writing experience; Masters or Phd degree is preferred</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>
Powered by JazzHR
vkGr46Taxg

Principal Medical Writer

<h3>Job Description</h3>
Job Description
We are looking for&nbsp;Technical Writer - Intermediate&nbsp;- Remote / Telecommute&nbsp;for our client in&nbsp;Boxborough, MA
Job Title:&nbsp;Technical Writer - Intermediate&nbsp;- Remote / Telecommute
Job Location:&nbsp;Boxborough, MA
Job Type: Contract
Job Description:
Pay Range: $30hr - $55hr
<ul>
<li>Works with staff to develop and deliver internal and external customer documentation to support client products and programs.&nbsp;</li>
<li>Writes, proofreads, formats and edits technical and marketing documentation (errata, databooks, white papers, application notes, schematics, product briefs, newsletters, product/vertical market presentations, and Web page content), as specified by the document owners and AES documentation process.&nbsp;</li>
<li>Ensure content is clean and accurate.&nbsp;</li>
<li>Edit content as needed in accordance with department guidelines and company standards.&nbsp;</li>
<li>Confer with technical personnel to ensure content accuracy and to resolve questions or contradictions.&nbsp;</li>
<li>Write and edit documentation with consistent style.&nbsp;</li>
<li>Usher documents through legal and technical review cycles; Publish final document versions in accordance with the corporate process.&nbsp;</li>
<li>Deliver documents on schedules determined by the document owners and program management.&nbsp;</li>
<li>Assist with the development of additional documents as required.</li>
</ul>
Experience:
<ul>
<li>As a technical writer; Experience writing structured documentation.</li>
<li>Experience using oXygen, XMetal, Quark, XML Mind or another XML editor, preferred.</li>
<li>Ability to work with scripting languages such as Python or Perl, preferred; Excellent writing, editing and organizational skills; Experience with Adobe FrameMaker, Word, Adobe Acrobat Pro, and Adobe Illustrator; Experience with Perforce and Doxygen, preferred.</li>
<li>Good understanding of engineering terminology used within the semiconductor industry.</li>
<li>Good understanding of x86-based computer systems and components; Proven interpersonal skills, leadership and teamwork, required.</li>
</ul>
Education:&nbsp;
<ul>
<li>Bachelor's degree with 6+ years of experience, or Masters with 3+ years of experience.</li>
</ul>
Company Descriptionvisit our career site to see all open positions @ <a href="http://jobs.cynetsystems.com" target="_blank">http://jobs.cynetsystems.com</a> 
<h3>Company Description</h3>
visit our career site to see all open positions @ <a href="http://jobs.cynetsystems.com" target="_blank">http://jobs.cynetsystems.com</a>

Technical Writer - Intermediate - Remote / Telecommute

<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, 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>
Powered by JazzHR
VuudYIvvKK

<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>
Powered by JazzHR
o07BIEguYb

3,613 Education Jobs