Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service.
**How you'll make an impact:**
+ Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department
+ Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties
+ Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle
+ Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams
+ Review and interpret study data analyses
+ Contribute to the generation of product life cycle plans (e.g., post-market surveillance).
**What you'll need (Required):**
+ Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria
+ Demonstrated track record in people management or equivalent work experience based on Edwards criteria
**What else we look for (Preferred):**
+ Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria
+ Medical writing or regulatory certification or equivalent work experience based on Edwards criteria
+ Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria
+ Experience working in a regulated industry or equivalent work experience based on Edwards criteria
+ Certification in related fields
+ Strong leadership in project and team management, including coaching and performance oversight.
+ Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines.
+ Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations.
+ Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed).
+ Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate.
+ Familiarity with coronary interventional and structural heart environments.
+ Proven ability to develop metrics demonstrating medical writing value to the business.
+ Ability to thrive in a fast-paced, dynamic environment with strict attention to detail.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $142,000 to $201,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**COVID Vaccination Requirement**
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
$142k-201k yearly 37d ago
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Medical Science Liaison - Rare Diseases East
Otsuka America Pharmaceutical Inc. 4.9
Medical writer job in Montpelier, VT
**Customer Engagement Model** Otsuka America Pharmaceutical, Inc. has launched a new customer engagement approach designed to better deliver on patient, caregiver, and HCP needs in an evolving healthcare environment. The new model is built around where patients get their care-locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care.
The local "ecosystem approach" creates a unified focus among account management, medical, patient access and market access to engage local healthcare systems and identify opportunities to improve the patient experience. Through this matrix model, customers will now experience more coordinated and seamless care with digital-enabled support to bridge care gaps.
In Otsuka's evolved customer engagement model, a Health Science Associates (HSA) will engage HCPs through a variety of in-person, virtual and digital tools, offering expanded expertise regarding products and the approved conditions they treat. Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership and real-world evidence. A Patient Education Liaison (PEL) works to inform, educate, and enhance the experience of patients throughout their care continuum.
The HSAs are led by Ecosystem Leads and grouped into regional areas. Ecosystem Leads are led by Regional Leads with significant autonomy to assess unique market priorities and customize decisions that reflect local customer needs. In the future, Otsuka will also be shifting to a team-based approach to drive customer engagement quality, accountability, and cohesion around patients and healthcare providers. Ultimately, it is all about putting customers at the center of everything they do.
**Position Overview** **- Medical** **Science Liaison** **(Senior Manager)**
As an integral member of the ecosystem team for Otsuka's new ecosystem-based customer engagement model, the Medical Science Liaison (MSL), Sr Mgr contributes to the development of the ecosystem strategic business plan and identifies key stakeholders that are vital to the ecosystem.
The Medical Science Liaison (MSL) is a credible partner responsible for providing clinical, scientific and health economic information related to disease states and the appropriate utilization of approved Otsuka products within an ecosystem. This field-based position will engage with Key Influencers (KIs), Local Practice Leaders (LPLs), healthcare providers, and patients' groups within their ecosystem, to further patient outcomes aligned with the overarching objectives of Otsuka. In collaboration with their ecosystem partners, CSLs contribute to the customization of the region business strategy to meet local ecosystem needs and are responsible for the medical and educational requirements of their customers. In addition, CSLs may be responsible for covering multiple products within a therapeutic area, as well as engaging in broad clinical and scientific discussions that impact patient care, resulting in rich customer insights shared within the ecosystem.
**There are 2 positions available**
**Key Activities and Responsibilities**
+ As part of the ecosystem team contributes a clinical and scientific perspective to the local execution plan that addresses ecosystem, and customer challenges, issues, and opportunities, to bring about improved patient care and outcomes. This extends to include coordination around execution of field activities.
+ Build, cultivate, and leverage external relationships with key scientific and medical customers and organizations within their ecosystem to ensure strong understanding of evolving healthcare trends, disease state, Otsuka products, systems, and services across the ecosystem landscape, including KIs, LPLs, Key Decision Makers (KDMs) and Patient Advocacy.
+ Maintain a comprehensive understanding of the ecosystem to ensure alignment with Otsuka's patient-centric strategy and priorities, including provision and delivery of optimal patient care.
+ To be a credible source of evidence-based information that demonstrates the value of Otsuka and its products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers, and other key stakeholders to apply practical real-world solutions to improve patient outcomes.
+ Build and cultivate important internal working relationships across the matrix team to ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical strategies within planned timelines.
+ Actively contribute to planning, content development, and dissemination of disease state information to customers in the field on a regular basis using the remote customer engagement platform.
+ Disseminate disease state and healthcare landscape information to customers in the field on a regular basis utilizing remote customer engagement platform.
+ Responsible for delivering the training and evaluation of promotional and disease state speakers.
+ Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem.
+ Collect and submit medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions, including sharing at the local ecosystem level.
+ Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance.
+ Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices.
**Qualifications**
+ Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health, (PharmD., M.D., PhD. or D.Ph.) is required.
+ Relevant therapeutic area knowledge is required.
+ Understanding of the interconnectivity of health systems, overall delivery of patient care and experience working with healthcare professionals and other decision makers.
+ Minimum of 3-5 years related work experience (clinical, health system or industry)
+ Outstanding business acumen; knows the industry, Otsuka's business model and value proposition, key competitors, and other marketplace factors/dynamics. Able to identify solutions with the overall goal of improved patient outcomes.
+ Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills: proven ability to achieve conflict resolution effectively and quickly with affected parties and work in a cross-functional environment.
+ Knows how to summarize and communicate complex information and business objectives in a concise and effective way during presentations and other interactions.
+ Understanding of industry legal, regulatory, and compliance landscape
+ Ability to work in an ambiguous environment undergoing transformation.
+ Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility.
+ Business travel, by air or car, up to 70% of time depending upon size of ecosystem.
+ Preferred living location is key city in ecosystem.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$147k yearly 31d ago
City Reporter
USA Today Co 4.1
Medical writer job in Burlington, VT
Are you a resourceful, language-loving reporter looking for a collaborative newsroom? Come write stories and make videos about Vermont's largest city - home to Ben and Jerry's, Bernie Sanders and the Burlington Free Press, part of the USA TODAY Network.
As our city reporter, you'll lead Burlington coverage every day with a beat that goes beyond dull meeting recaps. You'll have the opportunity to profile people and places; burrow into issues such as our housing crisis, homelessness and addiction; and switch easily between storyteller and watchdog modes while covering the city from all angles.
We're seeking someone eager to trawl public records, listen to locals and craft impact-focused stories that help people understand our community. This job offers the chance to drive a beat in a competitive media scene and get out in the field - we want a journalist who can track down sources and deliver work that shows life on the ground. The job relies on producing solid stories at a regular clip: We want you to be as enterprising in quick turns as you are with in-depth stories. Building sources and leads with strong beat coverage opens up avenues for investigations and more ambitious pieces. This is a hybrid role: You can divide your time between home and the office.
You'll be joining a tight team led by a recently hired editor who's looking to strengthen our local news package and trust with audiences. Our reporters enjoy a newsroom focused on workshopping, coaching and finding ways to tell stories others aren't. Plus: We do pies for birthdays.
While we remain centered on written articles - and still love the smell of news ink - we're looking for someone capable in the digital realm and comfortable meeting audiences where they are via vertical video stories. This is a new effort in which you can experiment and lead our local market.
Burlington is really more like a big town. (We've only got 45,000 residents, after all.) It's the economic and cultural capital of Vermont with a longstanding arts and music scene, acclaimed restaurants and craft breweries and easy access to the Green Mountains and Adirondacks across Lake Champlain. Outdoor recreation abounds here: bike paths, ski resorts, hiking trails, lakes. The University of Vermont and its medical center, two of the state's largest employers, are based in the city. Burlington's role as Vermont's population hub - and its urban feel in a mostly rural state - gives it great potential for a curious journalist.
As a state, we take a lot of pride in our stewardship of the environment, artisan food and communities that have some of the highest civic engagement in the country. We buck national trends in lots of ways - but Vermont is more complex than the holiday-card picture people often envision, and as a reporter with us, you'll have the chance to interrogate those ideas.
Requirements:
At least one to three years in journalism - freelance, internship and college outlet work considered. We'd like to hear from people of all experience levels, including longtime reporters. A degree in journalism, English, communications or a related field, or an equivalent combination of education and experience, is preferred.
Top-notch writing skills that prize clarity, flair and concision. Curiosity, creativity and a command of ethical reporting skills are much valued.
Ability and time-management skills to independently find and deliver stories while juggling deadlines each week.
Comfort with producing vertical videos, along with more traditional articles.
Willingness to work closely with an editor to grow skills and sharpen stories.
Comfort with using social media, Google Trends and SEO to find story ideas and figure out how we can best reach people.
A valid driver's license and reliable transportation.
We're excited to learn about you and how you can fit into our team. When you apply, don't limit your upload to a resume - show us what you've done. Please put together a single document file that includes the following, in this order:
Your resume, one to two pages.
A cover letter that describes how you would approach the job.
Links to three to six samples of work you're proud of. Show us what you've produced or had a hand in that best reflects what you can do here
It is important that these items be assembled into a single document and uploaded in PDF format. Completing these steps will ensure that your application receives the highest consideration.
#Newsgnt
#LI-CB1
$73k-102k yearly est. 30d ago
Technical Writer
ITW 4.5
Medical writer job in Montpelier, VT
Alpine, an ITW company, provides a suite of proprietary software, engineering services, and equipment that enables our customers to design, engineer, and fabricate structural building components (trusses & wall panels) using both light-frame wood construction and light-gauge steel materials. Partnering with truss manufacturers, lumber & building material suppliers, and homebuilders, we deliver solutions that improve productivity, quality, and profitability.
We're looking for a self-motivated **Technical Writer** to join our team in Fort Lauderdale, FL (remote/hybrid option available). In this role, you'll take full ownership of Alpine's online Help Documentation platform, translating complex product functionality into clear, concise, and engaging content. You'll work closely with Product Owners, developers, QA, and customer-facing teams to ensure every feature is thoroughly documented and easy to use.
ITW offers its employees a path for advancement, a competitive salary, and a comprehensive benefits package designed to help you care for yourself, your family, and your future.
**Job Description**
+ **Help Documentation Management**
+ Own Alpine's online Help platform across several software products.
+ Translate complex technical processes and workflows into clear, concise, and user-friendly content.
+ **Self-Directed Workflow Execution**
+ Monitor product Jira boards to identify and prioritize documentation needs.
+ Coordinate with Product Owners and subject-matter experts to gather accurate information and real-world use cases.
+ Maintain consistent publishing cadence and version control.
+ **Cross-Functional Collaboration**
+ Partner with product owners, developers, QA, and support to align documentation deliverables with release schedules.
+ Contribute to evolving documentation standards and system enhancements.
**Key Competencies for Success**
+ **Hands-On Product Expertise** Quickly learn complex software tools and accurately reflect real-world use cases in your writing.
+ **Self-Directed Execution** Proactively identify documentation gaps, manage multiple priorities, and meet deadlines with minimal oversight.
+ **Collaborative Communication** Skilled at extracting information from diverse stakeholders, resolving ambiguity, and integrating feedback.
**Qualifications**
+ Experience using Alpine truss design software or similar strongly preferred.
+ Excellent writing, editing, and organizational skills
+ 3+ years of technical writing experience, preferably in software or industrial products
+ Proven track record creating user manuals, online help, or knowledge-base content
+ Comfortable working in a fast-paced, agile environment and collaborating cross-functionally
**Compensation Information:**
Certain states require that pay information be included in job postings. The specific hiring rate within the posted pay range will depend on the successful candidate's qualifications, prior experience, and the geographic location. For example, In Illinois, the pay rate will be between $85,000-$105,000 (highly experienced).
_ITW is an equal opportunity employer. We value our colleagues' unique perspectives, experiences and ideas and create workplaces where everyone can develop their careers and perform to their full potential._
_As an equal employment opportunity employer, ITW is committed to equal employment opportunity and fair treatment for employees, beginning with the hiring process and continuing through all aspects of the employment relationship._
_All qualified applicants will receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, protected Veteran status or any other characteristic protected by applicable federal, state, or local laws._
$85k-105k yearly 60d+ ago
GDI - Technical Proposal Writer
Oracle 4.6
Medical writer job in Montpelier, VT
This role is ideal for someone who: + Is a meticulous reader and writer with a drive to learn about cloud technology at a national scale. + Can interpret expert input to craft proposal content that is informative _and_ persuasive. + Takes pride in the writing they produce and is always looking for ways to hone their craft.
+ Possesses knowledge and experience with any of public cloud providers including Oracle, Amazon Web Services (AWS), Azure or Google (GCP) architecture, tools, and cloud methodologies.
As a Technical Proposal Writer, you will be responsible for:
+ Writing technical proposals for US federal government customers seeking Oracle Cloud services and task order solutions.
+ Capturing and organizing content and knowledge from subject matter experts across Oracle and presenting it in clear, compliant, compelling format for technical and non-technical audiences.
+ Understanding, identifying, and documenting client requirements and driving compliance with those requirements across internal response teams.
+ Becoming an internal expert on Oracle GDI's proposal process.
+ Actively identify team process enhancements and work with team members to implement them.
+ Support response teams in online and in-person efforts to ensure the written components of the proposals are compelling and aligned.
+ Managing multiple versions of documents across separate systems, including maintaining current working documents throughout the proposal drafting process.
+ Employing superior written and verbal communication skills with attention to grammar, formatting, term consistency, and adherence to Oracle writing practices.
**EXPERIENCE**
**_Required_**
+ Minimum of four years' experience working in industry as a technical writer.
**_Desired_**
+ Minimum of six years' experience working in industry as a technical writer.
**EDUCATION AND CERTIFICATIONS**
**_Required_**
+ Bachelor's degree, any discipline.
**_Desired_**
+ APMP Foundation Level Certification or higher.
**Security Clearance:**
+ Candidates will need to be able to obtain and maintain a Secret / Top-Secret Security Clearance to work with the US Federal government _This is a remote position with the candidate willing to travel to the Reston, VA Office a few times quarterly._
**Responsibilities**
Responsible for participating in customer engagements to collaboratively design and implement solutions. Displays product/application understanding through more customized presentation demonstrations to customers and at conferences and events. May work directly with customers to gather requirements, develop architectures and translates business needs into solutions. Implements solutions and ensures successful deployments through code development and scripting. Supports customer from Proof of Concept (POC) through production deployment of services via resource configuration, planning, and customer education/training. Creates and distributes technical assets (white papers, solution code, blog posts, and video demonstrations). Serves as a technical point of contact for customers and sales on technical cloud solutions and customer success. Further builds business and technical acumen.
Disclaimer:
**Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.**
**Range and benefit information provided in this posting are specific to the stated locations only**
US: Hiring Range in USD from $37.88 to $60.63 per hour; from: $78,800 to $126,100 per annum. May be eligible for equity. Eligible for commission with an estimated pay mix of 70/30.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC2
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
$78.8k-126.1k yearly 5d ago
Community News Service Editor
University of Vermont 4.4
Medical writer job in Burlington, VT
Manage and guide all editing operations for the student-powered newsroom of the Community News Service, a local reporting program that provides news content to partner outlets across Vermont. The Community News Service is the local laboratory of UVM's Center for Community News, a national organization working to grow and strengthen the role of college reporting programs in addressing the local news crisis across the U.S. This role is a collaboration with UVM's College of Arts and Sciences. It's a fast-paced job for someone with news reporting and editing experience who wants to mentor the next generation of journalists and storytellers.
Desirable Qualifications
Ability to balance the competing needs of students, community partners and UVM , in close collaboration with journalism faculty. Enthusiastic about working with students who have no previous journalism experience and need more patience and guidance with each story. Willingness to help promote newsroom content and impact across Vermont.
$45k-60k yearly est. 60d+ ago
Medical Science Liaison - Rare Diseases West
Otsuka America Pharmaceutical Inc. 4.9
Medical writer job in Montpelier, VT
**Customer Engagement Model** Otsuka America Pharmaceutical, Inc. has launched a new customer engagement approach designed to better deliver on patient, caregiver, and HCP needs in an evolving healthcare environment. The new model is built around where patients get their care-locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care.
The local "ecosystem approach" creates a unified focus among account management, medical, patient access and market access to engage local healthcare systems and identify opportunities to improve the patient experience. Through this matrix model, customers will now experience more coordinated and seamless care with digital-enabled support to bridge care gaps.
In Otsuka's evolved customer engagement model, a Health Science Associates (HSA) will engage HCPs through a variety of in-person, virtual and digital tools, offering expanded expertise regarding products and the approved conditions they treat. Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership and real-world evidence. A Patient Education Liaison (PEL) works to inform, educate, and enhance the experience of patients throughout their care continuum.
The HSAs are led by Ecosystem Leads and grouped into regional areas. Ecosystem Leads are led by Regional Leads with significant autonomy to assess unique market priorities and customize decisions that reflect local customer needs. In the future, Otsuka will also be shifting to a team-based approach to drive customer engagement quality, accountability, and cohesion around patients and healthcare providers. Ultimately, it is all about putting customers at the center of everything they do.
**Position Overview** **- Medical** **Science Liaison** **(Senior Manager)**
As an integral member of the ecosystem team for Otsuka's new ecosystem-based customer engagement model, the Medical Science Liaison (MSL), Sr Mgr contributes to the development of the ecosystem strategic business plan and identifies key stakeholders that are vital to the ecosystem.
The Medical Science Liaison (MSL) is a credible partner responsible for providing clinical, scientific and health economic information related to disease states and the appropriate utilization of approved Otsuka products within an ecosystem. This field-based position will engage with Key Influencers (KIs), Local Practice Leaders (LPLs), healthcare providers, and patients' groups within their ecosystem, to further patient outcomes aligned with the overarching objectives of Otsuka. In collaboration with their ecosystem partners, CSLs contribute to the customization of the region business strategy to meet local ecosystem needs and are responsible for the medical and educational requirements of their customers. In addition, CSLs may be responsible for covering multiple products within a therapeutic area, as well as engaging in broad clinical and scientific discussions that impact patient care, resulting in rich customer insights shared within the ecosystem.
**There are 2 positions available**
**Key Activities and Responsibilities**
+ As part of the ecosystem team contributes a clinical and scientific perspective to the local execution plan that addresses ecosystem, and customer challenges, issues, and opportunities, to bring about improved patient care and outcomes. This extends to include coordination around execution of field activities.
+ Build, cultivate, and leverage external relationships with key scientific and medical customers and organizations within their ecosystem to ensure strong understanding of evolving healthcare trends, disease state, Otsuka products, systems, and services across the ecosystem landscape, including KIs, LPLs, Key Decision Makers (KDMs) and Patient Advocacy.
+ Maintain a comprehensive understanding of the ecosystem to ensure alignment with Otsuka's patient-centric strategy and priorities, including provision and delivery of optimal patient care.
+ To be a credible source of evidence-based information that demonstrates the value of Otsuka and its products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers, and other key stakeholders to apply practical real-world solutions to improve patient outcomes.
+ Build and cultivate important internal working relationships across the matrix team to ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical strategies within planned timelines.
+ Actively contribute to planning, content development, and dissemination of disease state information to customers in the field on a regular basis using the remote customer engagement platform.
+ Disseminate disease state and healthcare landscape information to customers in the field on a regular basis utilizing remote customer engagement platform.
+ Responsible for delivering the training and evaluation of promotional and disease state speakers.
+ Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem.
+ Collect and submit medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions, including sharing at the local ecosystem level.
+ Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance.
+ Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices.
**Qualifications**
+ Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health, (PharmD., M.D., PhD. or D.Ph.) is required.
+ Relevant therapeutic area knowledge is required.
+ Understanding of the interconnectivity of health systems, overall delivery of patient care and experience working with healthcare professionals and other decision makers.
+ Minimum of 3-5 years related work experience (clinical, health system or industry)
+ Outstanding business acumen; knows the industry, Otsuka's business model and value proposition, key competitors, and other marketplace factors/dynamics. Able to identify solutions with the overall goal of improved patient outcomes.
+ Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills: proven ability to achieve conflict resolution effectively and quickly with affected parties and work in a cross-functional environment.
+ Knows how to summarize and communicate complex information and business objectives in a concise and effective way during presentations and other interactions.
+ Understanding of industry legal, regulatory, and compliance landscape
+ Ability to work in an ambiguous environment undergoing transformation.
+ Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility.
+ Business travel, by air or car, up to 70% of time depending upon size of ecosystem.
+ Preferred living location is key city in ecosystem.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$147k yearly 33d ago
City Reporter
Gannett Co. Inc. 4.0
Medical writer job in Burlington, VT
Are you a resourceful, language-loving reporter looking for a collaborative newsroom? Come write stories and make videos about Vermont's largest city - home to Ben and Jerry's, Bernie Sanders and the Burlington Free Press, part of the USA TODAY Network.
As our city reporter, you'll lead Burlington coverage every day with a beat that goes beyond dull meeting recaps. You'll have the opportunity to profile people and places; burrow into issues such as our housing crisis, homelessness and addiction; and switch easily between storyteller and watchdog modes while covering the city from all angles.
We're seeking someone eager to trawl public records, listen to locals and craft impact-focused stories that help people understand our community. This job offers the chance to drive a beat in a competitive media scene and get out in the field - we want a journalist who can track down sources and deliver work that shows life on the ground. The job relies on producing solid stories at a regular clip: We want you to be as enterprising in quick turns as you are with in-depth stories. Building sources and leads with strong beat coverage opens up avenues for investigations and more ambitious pieces. This is a hybrid role: You can divide your time between home and the office.
You'll be joining a tight team led by a recently hired editor who's looking to strengthen our local news package and trust with audiences. Our reporters enjoy a newsroom focused on workshopping, coaching and finding ways to tell stories others aren't. Plus: We do pies for birthdays.
While we remain centered on written articles - and still love the smell of news ink - we're looking for someone capable in the digital realm and comfortable meeting audiences where they are via vertical video stories. This is a new effort in which you can experiment and lead our local market.
Burlington is really more like a big town. (We've only got 45,000 residents, after all.) It's the economic and cultural capital of Vermont with a longstanding arts and music scene, acclaimed restaurants and craft breweries and easy access to the Green Mountains and Adirondacks across Lake Champlain. Outdoor recreation abounds here: bike paths, ski resorts, hiking trails, lakes. The University of Vermont and its medical center, two of the state's largest employers, are based in the city. Burlington's role as Vermont's population hub - and its urban feel in a mostly rural state - gives it great potential for a curious journalist.
As a state, we take a lot of pride in our stewardship of the environment, artisan food and communities that have some of the highest civic engagement in the country. We buck national trends in lots of ways - but Vermont is more complex than the holiday-card picture people often envision, and as a reporter with us, you'll have the chance to interrogate those ideas.
Requirements:
At least one to three years in journalism - freelance, internship and college outlet work considered. We'd like to hear from people of all experience levels, including longtime reporters. A degree in journalism, English, communications or a related field, or an equivalent combination of education and experience, is preferred.
Top-notch writing skills that prize clarity, flair and concision. Curiosity, creativity and a command of ethical reporting skills are much valued.
Ability and time-management skills to independently find and deliver stories while juggling deadlines each week.
Comfort with producing vertical videos, along with more traditional articles.
Willingness to work closely with an editor to grow skills and sharpen stories.
Comfort with using social media, Google Trends and SEO to find story ideas and figure out how we can best reach people.
A valid driver's license and reliable transportation.
We're excited to learn about you and how you can fit into our team. When you apply, don't limit your upload to a resume - show us what you've done. Please put together a single document file that includes the following, in this order:
Your resume, one to two pages.
A cover letter that describes how you would approach the job.
Links to three to six samples of work you're proud of. Show us what you've produced or had a hand in that best reflects what you can do here
It is important that these items be assembled into a single document and uploaded in PDF format. Completing these steps will ensure that your application receives the highest consideration.
#Newsgnt
#LI-CB1
$47k-67k yearly est. 32d ago
Senior Document Writer - New Group Business
CVS Health 4.6
Medical writer job in Vermont
At CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nation's leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000 purpose-driven colleagues - caring for people where, when and how they choose in a way that is uniquely more connected, more convenient and more compassionate. And we do it all with heart, each and every day.
**Position Summary**
Under general supervision the Senior Document Writer drafts, reviews, and edits medical, dental and vision plan documents. This position will support plan document needs for new business by creating plan documents and summaries of benefits and coverage (SBC's).
**Required Qualifications**
+ 2-4 years with extensive plan writing experience supporting self-funded or fully insured plans.
+ 2-4 years of experience in the health insurance industry.
+ Proficiency with Microsoft Office Word, Excel, SharePoint, and Outlook applications.
+ Must be an independent, critical thinker who is a self-starter and deadline driven.
+ Strong attention to detail and accuracy performing at high levels in a fast paced and constantly changing work environment.
**Preferred Qualifications**
+ Knowledge and experience in medical, dental, and vision benefits.
+ Knowledge and experience with benefit terminology.
+ General understanding of compliance and regulatory issues (ERISA, HIPAA, ACA, COBRA).
+ Organizes time efficiently to ensure that tasks are completed to meet or exceed deadlines.
+ Strong verbal and written communication skills.
**Education**
+ High School Diploma or GED.
**Anticipated Weekly Hours**
40
**Time Type**
Full time
**Pay Range**
The typical pay range for this role is:
$18.50 - $42.35
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors. This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above.
Our people fuel our future. Our teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong.
**Great benefits for great people**
We take pride in our comprehensive and competitive mix of pay and benefits - investing in the physical, emotional and financial wellness of our colleagues and their families to help them be the healthiest they can be. In addition to our competitive wages, our great benefits include:
+ **Affordable medical plan options,** a **401(k) plan** (including matching company contributions), and an **employee stock purchase plan** .
+ **No-cost programs for all colleagues** including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching.
+ **Benefit solutions that address the different needs and preferences of our colleagues** including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility.
For more information, visit *****************************************
We anticipate the application window for this opening will close on: 01/26/2026
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws.
We are an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring, promotion, or any other personnel action based on race, ethnicity, color, national origin, sex/gender, sexual orientation, gender identity or expression, religion, age, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
$18.5-42.4 hourly 2d ago
Senior Medical Writer- FSP
Parexel 4.5
Medical writer job in Montpelier, VT
The Senior MedicalWriter will research, create, and edit all documents associated with clinical research. The Senior MedicalWriter may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior MedicalWriter also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input.
**Key Accountabilities** :
**Author Clinical Documents**
+ Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable.
+ Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
+ Manage ongoing and/or revised project documentation and correspondence.
**Quality Control**
+ Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
+ Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission.
**Project Management**
+ Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project.
+ Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives.
+ Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program.
+ Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents.
+ Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget.
+ Keep client and team informed of project status.
+ Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences.
+ Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence.
+ Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management.
+ Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements.
+ Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed.
**Client** **Liaison/Service**
+ Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.
+ Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon.
+ Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management.
+ Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management.
+ If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects.
**Training/Compliance**
+ Keep abreast of new advances in medical writing and regulatory issues.
+ Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management.
+ Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate.
+ Develop and present external training courses.
**General**
+ Attend departmental and company meetings as necessary.
+ Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform
+ Analyze efficiency of work and discuss improvement ideas with Medical Writing
+ Services management and colleagues, e.g., evaluation of software to increase productivity and document quality.
**Skills:**
+ Excellent interpersonal, negotiation, verbal, and written communication skills.
+ A flexible attitude with respect to work assignments and new learning.
+ Motivation to work consistently in a fast-paced, rapidly changing environment.
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
+ Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
+ Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.
+ Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
+ Understands and satisfies client needs.
+ Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.
+ Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.
**Knowledge and Experience** :
+ Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
+ Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects.
+ Knowledge of resource management and productivity metric management.
+ Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
+ Ability to travel.
+ Fluent in written and spoken English.
**Education:**
+ Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
\#LI-KW1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$88k-128k yearly est. 36d ago
MultiMedia Journalist
Tribune Broadcasting Company II 4.1
Medical writer job in Colchester, VT
FOX44 (WFFF-TV) and ABC22 (WVNY-TV) in Burlington, Vermont has an immediate opening for an energetic MultiMedia Journalist Reporter.
The MultiMedia Journalist Reporter produces reports, shoots, writes, voices, edits, and feeds news production content for all platforms in a manner that is clear, engaging, and meaningful to news consumers.
Duties & Responsibilities:
Reports news stories for broadcast, describing the background and details of events
Arranges interviews with people who can provide information about stories
Reviews copy and corrects errors in content, grammar, and punctuation, following prescribed editorial style and formatting guidelines
Reviews and evaluates notes taken about event aspects to isolate pertinent facts and details
Determines a story's emphasis, length, and format, and organizes material accordingly
Researches and analyzes background information related to news stories to be able to provide complete and accurate information
Gathers information about events through research, interviews, experience, or attendance at political, news, sports, artistic, social, or other functions
Pitches stories to news managers and news producers which are relevant to the local community
Receives assignments and evaluates leads and tips to develop story ideas
Discusses issues with producers and/or news managers to establish priorities or positions
Checks reference materials such as books, news files or public records to obtain relevant facts
Revises work to meet editorial approval or to fit time requirements
Shoots and edits news events and news reports
Produces and presents reports for all platforms
Ensures that all content meets company standards for journalistic integrity and production quality
Writes stories for the web and other eMedia platforms
Interacts with viewers/users on social media sites
Performs special projects and other duties as assigned
Requirements & Skills:
Bachelor's degree in Broadcast Journalism, or a related field, or an equivalent combination of education and work-related experience
Fluency in English
Excellent communication skills, both oral and written with the ability to
ad lib
when required
Superior on-air presence
Proficiency with computers, telephones, copiers, scanners, fax machines and other office equipment
Ability to meet deadlines, prioritize assignments and handle multiple tasks simultaneously
Valid driver's license with a good driving record
Flexibility to work any shift
Benefits:
Pay: $15 - $20 per hour, depending on experience
Competitive compensation package with medical, dental, vision, life insurance, 401(K), and more.
$15-20 hourly Auto-Apply 60d+ ago
Principal Medical Writer / Senior Medical Writer - US - FSP
Parexel 4.5
Medical writer job in Montpelier, VT
The Senior MedicalWriter will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff.
**Key Accountabilities** :
**Author Clinical Documents**
+ Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.
+ Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
+ Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable.
+ Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
+ Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing.
**Quality Control**
+ Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
+ Confirm data consistency and integrity across the document.
+ Prepare documents for publishing readiness, when applicable.
+ Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable.
+ Provide suggested alternative content when contributors provide content that does not meet document needs.
+ Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
**Document Project Management**
+ Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
+ Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client.
+ Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
+ Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus.
+ Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate MedicalWriter for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator.
+ Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship.
**Training/ Compliance**
+ Attend and complete mandatory, corporate, project-specific, and departmental training as required.
+ Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department.
+ Assist in the training/mentoring of new staff as well as less experienced departmental members.
**General**
+ Attend departmental and company meetings as necessary.
+ Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform.
+ When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents.
+ Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures.
**Skills:**
+ Excellent interpersonal, verbal, and written communication skills.
+ Ability to consistently produce documents of high quality.
+ Demonstrates attention to details and proactivity.
+ Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
+ A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
+ Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
+ Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
+ Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
+ Understands and satisfies client needs.
+ Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.
+ Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.
**Knowledge and Experience** :
+ Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
+ Extensive clinical/scientific writing skills.
+ Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
+ Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
+ Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
+ If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite
**Education:**
+ Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
\#LI-CF1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.