Senior Manager, Medical Writing
News writer job in Dover, DE
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.
Technical Anchor - DevSecOps & Platform Engineering
News writer job in Dover, DE
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than ourselves. Are you ready to change the way the world moves?
Enterprise Technology plays a critical part in shaping the future of mobility. If you're looking for the chance to leverage advanced technology to redefine the transportation landscape, enhance the customer experience and improve people's lives, this is the opportunity for you. Join us and challenge your IT expertise and analytical skills to help create vehicles that are as smart as you are.
Seeking a **Technical Anchor** to:
+ Design, develop, and maintain secure and scalable cloud infrastructure platforms using the latest DevSecOps and Platform Engineering methodologies
+ Create and implement best practices and processes for code quality, security, performance, and scalability using Sonarqube, Cycode, DAST, SAST & FOSSA
+ Possess strong experience using GCP specific services like Compute Engine, CloudRun, GKE, Cloud operations suite, Service Mesh, Anthos, Pub/Sub, Dataflow, Cloud Scheduler, Bigtable, AlloyDB and other managed services.
+ Possess experience with Google Cloud infrastructure provisioning including VPC, Subnet, Gateway, Security groups, managed services, Kubernetes Cluster etc.
+ Possess expertise with automating Infrastructure as Code using Terraform, Packer, Ansible, Shell Scripting and ArgoCD
+ Lead cross-functional teams to drive the adoption of DevSecOps and Platform Engineering best practices across the organization
+ Possess experience in implementing Auto scaling, Disaster Recovery, High Availability, Multi-region Active/Active & Active/Passive configurations & best practices is added advantage.
+ Evaluate and select appropriate technologies and tools to support the development and deployment of products on the eCommerce foundation layer
+ Collaborate with stakeholders to understand business needs and requirements, and translate them into technical and non-functional specifications
+ Work with Product teams to understand their pain points and increase the Developer Experience through Platform Engineering Capabilities
+ Possess experience with Internal Developer Platform (IDP) like Backstage and address developer productivity
+ Strategize & work with leaders across Ford's Enterprise Architecture, IT Operations to make significant, measurable impact on the eCommerce Platform
+ Possess expertise with patch management, APM tools like Dynatrace/AppDynamics, Prometheus, Grafana, ELK for monitoring and alerting.
+ Possess experience in Elastic Search service offerings in K8s.
+ Possess experience in Cloud FinOps to optimize Cloud Infrastructure Consumption Cost
**What you'll do...**
+ Responsible for overall Infrastructure Architecture and evolution of next gen platforms. Ideal candidates will research the existing products and recommend solutions to run workloads in futuristic Infrastructure Architecture landscape
+ Conduct and perform Infrastructure as Code reviews, automate and deploy Cloud Infrastructure
+ Experience with implementing AIOps in the Platform Engineering space and increase Developer Experience
+ Identify code vulnerabilities and performance bottlenecks at the Infrastructure Layer, and recommend solutions to improve the overall quality and performance of the sub systems
+ Create and maintain technical documentation, including architecture diagrams, design documents, and operational procedures for High Availability, Disaster Recovery scenarios
+ Analyze kernel logs, network stats, APM metrics, application logs to troubleshoot CPU/Memory/Resource hot spots, API latency and application/platform health
+ Analyze and identify root-cause and fix complex performance problems involving multiple teams, networks, and software in GCP that relate to scaling and performance
+ Build Automation for repeatable DevSecOps tasks and help with improving Software Engineers' productivity
+ Mentoring Team members to scale and perform at their next level
+ Thought Leadership around Shift Left (Quality, Security, OSS use) & Shift Right (Platform Engineering) and increasing adoption in the eCommerce Platform
**You'll have...**
+ Bachelor's degree in Computer Science, Engineering, Information Technology or related
+ 5+ years of experience in the Software Development and Platform Engineering domain
+ Experience with the following: Microservices architectures, Micro Front-end Cloud-Native architectures, Event-driven architectures, APIs, Domain-Driven Design, Public Cloud (Google Cloud), Serverless, Elastic Search, Kubernetes, Docker, DevSecOps, building scalable, reliable, available solutions, and/or performance testing.
+ Strong technical background with the capability of being hands-on and earn the respect and ability to mentor top individual technical talent.
+ Experience in Cloud Native systems, Transactional Systems, Multi-Tenancy, five-nines availability and Containerization technologies.
+ Experience in collaborating and partnering with other technical domain experts such as cloud, security, SRE and Release Mgmt. processes
+ Proven facilitation skills - able to effectively drive discussion among diverse perspectives and reach a decision or recommendation
+ Proven ability to work closely with architect and leadership teams.
+ Effectively work with cross-functional teams across the organization - inside and outside of the technology and software organization
+ Excellent communication and interpersonal skills
+ Ability to work effectively in a remote/virtual work setting with other global team members
**Even better, you may have...**
+ Master's degree in Computer Science, Engineering Information Technology or related
+ GCP Cloud Architect and/or CKA Certifications
You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply!
As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder...or all of the above? No matter what you choose, we offer a work life that works for you, including:
- Immediate medical, dental, vision and prescription drug coverage
- Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more
- Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more
- Vehicle discount program for employees and family members and management leases
- Tuition assistance
- Established and active employee resource groups
- Paid time off for individual and team community service
- A generous schedule of paid holidays, including the week between Christmas and New Year's Day
- Paid time off and the option to purchase additional vacation time.
For a detailed look at our benefits, click here:
*******************************
This position is a range of salary grade 8.
SOUTHEAST MI RESIDENTS: This role is posted as remote unless you reside within 50 miles of Dearborn, MI-in which case we request on-site presence up to 4 days a week.
Visa sponsorship is available for this position.
Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire.
We are an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status. In the United States, if you need a reasonable accommodation for the online application process due to a disability, please call **************.
\#LI-Remote
**Requisition ID** : 51212
Aml Sar Writer
News writer job in New Castle, DE
Artech Information Systems is the #1 Largest Women-Owned IT Staffing Company in the U.S. and an employer of choice for over 7,200 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
Job Description
The AML Analysts within the CRIU review system-generated and manual cases for activity conducted by clients. The Senior Compliance Analyst is responsible for managing a caseload of investigations, perform analysis and follow-up and work cases from beginning to completion according to AML procedures and policies. Cases are generated from sources which include Automated Alerts (EAP, Mantas), and Manual referrals.
Responsibilities include:
• Document and report case review/investigation findings and prepare case files for review (e.g. media search results, copies of statements/checks, results from internal system searches etc.)
• Conduct research over available Bank systems, the Internet and Databases consistent with the resolution of investigations.
• Collect and examine financial statements/transaction data and other documents to assist in identifying unusual transaction patterns
• Follow-up with additional Point(s) of Contact (POC) as needed to identify additional information in support of the case.
• Document all research and analysis conducted in the Case Management System
• Create Suspicious Activity Reports (SARs); and recommend relationship retention or termination; and track account closures as required.
• Liaise with other CRIU units, ACRM, the Business, CSIS, FIU Legal, Trade Surveillance, and Law Enforcement, where applicable.
Qualifications
• Bachelor's Degree Required or equivalent experience.
• 1-5 years' experience in reviewing customer transactions and information for potentially suspicious activity and performing AML or financial investigations
• Experience in writing and preparing Suspicious Activity Reports (SARs) in accordance with applicable regulatory requirements preferred.
• CAMS Certification is a plus
• Knowledge of the laws applicable to money laundering, terrorist financing, and other applicable financial/securities related crimes (e.g., insider trading, market manipulation), including the Bank Secrecy Act (BSA), The USA PATRIOT Act, US Treasury AML guidelines, OFAC, SEC, FINRA, FRB, FinCEN requirements, and SAR requirements
• General understanding of Senior Public Figures, Money Service Businesses, Wealth Management and Retail Banking preferred as well as compliance with those business segments.
Excellent organizational, time management, and project management skills.
• Excellent research skills including experience with online search tools.
• Advanced proficiency in Microsoft Office (i.e., MS-Word, MS-Excel, MS-Access, MS-PowerPoint and MS-Outlook)
• Strong writing, analytical and communications skills. Must be able to multitask and complete projects on time.
• Strong Attention to detail and follow-up skills
• Should be a self-starter, and organized, and must have the ability to work independently, without supervision.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Senior Document Writer - New Group Business
News writer job in Dover, DE
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: 12/22/2025
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.
Senior Copywriter
News writer job in Wilmington, DE
Global Marketing
CSC is seeking an experienced and detail-oriented senior copywriter to join our global marketing team. This role will support our Corporate and Legal Solutions (CLS) and Digital Brand Services (DBS) businesses, ensuring every piece of content is clear and consistent, represents our value proposition, and aligns with CSC's brand standards. The role will further support executive-level communications for our C-suite, with the successful candidate having the ability to capture the authentic voices of our most senior leaders.
This role will work closely with marketing managers, designers, and subject matter experts to create, refine, and elevate content across all marketing channels. While strong editing will be critical for this role, the ability to write original content is equally important, whether it's crafting social copy, web pages, articles, or emails.
This position is ideal for a proactive editor-writer hybrid-someone who not only catches errors but also identifies opportunities to improve flow, impact, and audience engagement.
Key responsibilities:
• Write and refine content across all channels-including reports, blogs, web copy, emails, and social media-to ensure clarity, accuracy, and adherence to brand voice.
• Work with C-level leaders to capture their authentic voices and produce copy (internal emails, speeches, social copy) in a timely manner.
• Transform complex legal, compliance, domain security, digital brand, and fraud protection copy into clear, accessible language for senior decision-makers.
• Review structure, tone, and readability, ensuring consistency and alignment with campaign goals.
• Proactively identify and recommend improvements, from tightening structure and tone to reframing copy for stronger engagement.
• Collaborate with writers, designers, and campaign teams to maintain message consistency and optimize content performance.
• Help develop and maintain editorial guidelines, ensuring accuracy and quality across all global content.
• Stay informed about market trends, regulatory updates, and digital risks to ensure content remains current and compliant.
• Provide editorial support for cornerstone assets and repurpose them into new formats such as blogs, carousels, and emails.
Requirements
• A degree in journalism, communications, English, or a related field.
• A minimum of eight years' experience in B2B content editing or writing, preferably within a corporate or agency setting.
• Strong editorial judgment with the ability to simplify complex topics while maintaining technical accuracy.
• Demonstrated ability to both edit and originate content across multiple formats-including web, email, social, and thought leadership.
• Excellent command of grammar, structure, and style, with an eye for detail and consistency.
• Experience collaborating with subject matter experts and ensuring factual accuracy.
• Skilled at managing multiple priorities, deadlines, and feedback rounds with minimal oversight.
• Comfortable using Microsoft Office, Adobe Acrobat, and shared cloud platforms like OneDrive or SharePoint.
• Experience using project management platforms such as Wrike to track workflows and deadlines.
• A portfolio demonstrating a range of edited and original work across digital and long-form formats.
Preferred
• Experience editing or writing about regulatory compliance, corporate governance, domain management, or cybersecurity.
• Experience using, or a willingness to be trained in, AI tools and large language models (e.g., ChatGPT) to support content ideation, repurposing, and workflow efficiency, while maintaining editorial integrity and tone of voice.
Ideal candidate
This role is ideal for a strategic, proactive editor who combines precision with creativity. The role requires someone who is as confident rewriting a complex paragraph as they are tightening a headline, can spot inconsistencies others miss, and can suggest improvements that make copy sharper, clearer, and more effective.
The ideal candidate can balance editorial rigor and original thinking, helping ensure that every piece of content from CSC not only meets our brand standards but elevates the story we tell across global markets.
Auto-ApplyStaff Writer, Pet Health
News writer job in Wilmington, DE
At Forbes Advisor, our mission is to help readers turn their aspirations into reality. We arm people with trusted advice and guidance, so they can make informed decisions they feel confident in and get back to doing the things they care about most.
We are an experienced team of industry experts dedicated to helping readers make smart decisions and choose the right products with ease. Marketplace boasts decades of experience across dozens of geographies and teams, including Content, SEO, Business Intelligence, Finance, HR, Marketing, Production, Technology and Sales. The team brings rich industry knowledge to Marketplace's global coverage of consumer credit, debt, health, home improvement, banking, investing, credit cards, small business, education, insurance, loans, real estate and travel.
Job Description
Forbes Advisor is looking for a staff writer with pet health and veterinary service writing and reporting experience.
Pet Health. We want to guide our readers and to make smart, informed decisions beyond the veterinary clinics with the most accurate and up-to-date information, delivered through best-ofs, interviews with licensed veterinarians, product reviews, engaging content and data- and SEO-driven journalism. If you're passionate about service journalism and you're looking for challenges and opportunities similar to those of a startup, with the benefits of a seasoned and successful company, then read on:
Responsibilities:
Write helpful, accurate and engaging interviews, how-tos, roundups, best-ofs and product reviews
Update stories with timely information as needed
Brainstorm and generate story ideas and coordinate with your editors to bring them to life
Leverage data and SEO best practices when writing and reporting
Gather a team of veterinary experts who you can tap for quotes and interviews
Requirements:
Previous experience in pet health journalism
2-4 years of experience in online journalism and writing-focused roles
Strong understanding of the veterinary space
Experience with SEO best practices preferred
Extremely organized and detail-oriented
Nimble and open to quick changes in strategy
Ability to work in a startup environment
#LI-NM1
Additional Information
Forbes Advisor 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.
Scientific Writer Toxicology/DMB
News writer job in Wilmington, DE
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function) The Scientific Writer would be shared with the Toxicology and DMB departments and will be responsible for the development of nonclinical documents for submissions to regulatory authorities globally.
Provides Toxicology and DMB writing expertise to cross-functional project teams to ensure that Toxicology and DMB documents (eg, bioanalysis (BA), toxicokinetic (TK) and pharmacokinetic (PK) reports, Pharmacokinetics Written Summary (2.
6.
4) and Toxicology Written Summary (module 2.
6.
6), Health authority responses) accurately and consistently present key data-driven messages, in close collaborations with Toxicology and DMB leads, in accordance with regulatory requirements.
Writes to ensure the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation.
Responsible for the scientific writing activities of multiple compounds and serves as the lead writer for individual summary documents.
Has a broad understanding of Toxicology and DMB scientific and clinical development processes and global regulatory document standards.
Essential Functions of the Job (Key responsibilities) · Develop nonclinical-related regulatory documents for submission to regulatory agencies globally, in close collaborations with the program tox and DMB leads, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with Discovery and Development project timelines and corporate objectives.
· Manage scientific writing projects for GLP and non-GLP reports, including developing timelines (working with the project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
· Participate in Discovery and Development program and cross-functional meetings to provide input regarding scientific writing deliverables, timelines, and any process(es) needed for the completion of Toxicology and DMB- related regulatory documents.
· Review other documents associated with the assigned project(s) (eg, Pharmacometric analysis plans), as appropriate.
Qualifications (Minimal acceptable level of education, work experience, and competency) · A degree in a relevant scientific/regulatory field is preferred, including Tox or DMB background.
Equivalent experience or education will also be considered.
· Relevant experience in scientific writing within the biopharmaceutical/CRO industry or nonclinical development is preferred.
· Proficiency in organizing and communicating Tox and DMB information required, working collaboratively with Tox and DMB leads.
· Strong organizational, time management, and project management skills are required.
· Excellent communication skills, including verbal, written, and interpersonal abilities, are needed to collaborate effectively in a team environment.
· Understanding and knowledge of FDA/EMA regulatory requirements preferred, but not required, to encourage diverse applicants who may bring other valuable skills and experiences.
· Proficient in MS Word or similar word processing software.
Experience with an electronic document management system and templates is preferred.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
AML SAR WRITER
News writer job in New Castle, DE
Artech Information Systems is the #1 Largest Women-Owned IT Staffing Company in the U.S. and an employer of choice for over 7,200 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
Job Description
The AML Analysts within the CRIU review system-generated and manual cases for activity conducted by clients. The Senior Compliance Analyst is responsible for managing a caseload of investigations, perform analysis and follow-up and work cases from beginning to completion according to AML procedures and policies. Cases are generated from sources which include Automated Alerts (EAP, Mantas), and Manual referrals.
Responsibilities include:
• Document and report case review/investigation findings and prepare case files for review (e.g. media search results, copies of statements/checks, results from internal system searches etc.)
• Conduct research over available Bank systems, the Internet and Databases consistent with the resolution of investigations.
• Collect and examine financial statements/transaction data and other documents to assist in identifying unusual transaction patterns
• Follow-up with additional Point(s) of Contact (POC) as needed to identify additional information in support of the case.
• Document all research and analysis conducted in the Case Management System
• Create Suspicious Activity Reports (SARs); and recommend relationship retention or termination; and track account closures as required.
• Liaise with other CRIU units, ACRM, the Business, CSIS, FIU Legal, Trade Surveillance, and Law Enforcement, where applicable.
Qualifications
• Bachelor's Degree Required or equivalent experience.
• 1-5 years' experience in reviewing customer transactions and information for potentially suspicious activity and performing AML or financial investigations
• Experience in writing and preparing Suspicious Activity Reports (SARs) in accordance with applicable regulatory requirements preferred.
• CAMS Certification is a plus
• Knowledge of the laws applicable to money laundering, terrorist financing, and other applicable financial/securities related crimes (e.g., insider trading, market manipulation), including the Bank Secrecy Act (BSA), The USA PATRIOT Act, US Treasury AML guidelines, OFAC, SEC, FINRA, FRB, FinCEN requirements, and SAR requirements
• General understanding of Senior Public Figures, Money Service Businesses, Wealth Management and Retail Banking preferred as well as compliance with those business segments.
Excellent organizational, time management, and project management skills.
• Excellent research skills including experience with online search tools.
• Advanced proficiency in Microsoft Office (i.e., MS-Word, MS-Excel, MS-Access, MS-PowerPoint and MS-Outlook)
• Strong writing, analytical and communications skills. Must be able to multitask and complete projects on time.
• Strong Attention to detail and follow-up skills
• Should be a self-starter, and organized, and must have the ability to work independently, without supervision.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Senior Medical Writer - US - FSP
News writer job in Dover, DE
The Senior Medical Writer 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 Medical Writer 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.
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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.
Senior Medical Writer- FSP
News writer job in Dover, DE
The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer 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 Medical Writer 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.