Delaware Online/The News Journal, part of the USA TODAY NETWORK, is seeking an experienced reporter who can cover the state's civil courts and its complexities, a beat rich with stories that touch not just Delaware but a national audience given the state's global role in business news through the Chancery Court. The successful candidate with understand when to jump on a breaking story about Elon Musk heading to Delaware when Tesla is wrapped up in litigation, while also knowing when to dig in to the watchdog story about why a local hospital system is being sued repeatedly for the same claims. This reporter will be responsible for digging into civil filings in Delaware courts, mining lawsuits for big names, agencies and drama, and turning fast, enterprise stories that interest readers and keep them coming back for more. This reporter will also work in tandem with others in the newsroom when lawsuits and coverage expands onto other beats - we know one person can't tackle it all.
Additionally, this reporter will be responsible for carving out coverage and zeroing in on Delaware's unique Chancery Court, where big business decisions happen every day and some of the nation's movers and shakers must frequent due to the state's rosy complexion for corporations. This coverage would provide not just important stories for Delaware, but also serve as a touchpoint for other USA TODAY Network following business happenings and lawsuits that affect their coverage areas. A willingness to collaborate is key.
In short, we want someone who writes for readers, identifying the stories that will interest a variety of audiences - and a reporter who understands that looks different day to day. This beat requires a reporter who can juggle multiple assignments and work on breaking news as well as short- and long-term enterprise. You must understand analytics and how to use that information to your advantage. And you must be ready and willing to spend time in the Wilmington courthouses, getting to know the players and showing up again and again to get the sourcing needed to tell these stories. This is not a remote position.
Requirements:
Bachelor's or master's in communications, journalism or an equivalent combination of education and experience.
At least 3 years of experience at a daily news organization.
Familiarity with digital storytelling tools and techniques, especially video for both on site and social.
Outstanding core journalism skills, including writing, spelling, grammar and AP style.
Must thrive in a competitive news market while possessing a collaborative spirit.
Deep understanding of journalism ethics.
Experience with social media, online metrics, third party tools and content management systems.
Ability to multi-task.
This role requires a valid driver's license, reliable transportation, and the minimum liability insurance required by state law.
Application Instructions We are eager to learn more about you and how you fit this role. When you apply, don't limit your upload to a resume; show us what you've done. To do so, put together a single document file that includes the following, in this order:
Your resume - one to two pages.
A cover letter that outlines how you would approach the job.
Links to 3-5 online samples of your work. Show us what you've produced or had a hand in that best reflects what you can do in your desired role.
It is important that these items be assembled in a single document and uploaded in PDF format. Completing these steps will ensure that your application receives the highest consideration.
#Newsgnt#LI-CB1
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
$90k-112k yearly est. 60d+ ago
Senior Document Writer - New Group Business
CVS Health 4.6
Reporter job in Delaware
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 7d ago
Delaware Courts Reporter
Gannett Co. Inc. 4.0
Reporter job in New Castle, DE
Delaware Online/The News Journal, part of the USA TODAY NETWORK, is seeking an experienced reporter who can cover the state's civil courts and its complexities, a beat rich with stories that touch not just Delaware but a national audience given the state's global role in business news through the Chancery Court. The successful candidate with understand when to jump on a breaking story about Elon Musk heading to Delaware when Tesla is wrapped up in litigation, while also knowing when to dig in to the watchdog story about why a local hospital system is being sued repeatedly for the same claims. This reporter will be responsible for digging into civil filings in Delaware courts, mining lawsuits for big names, agencies and drama, and turning fast, enterprise stories that interest readers and keep them coming back for more. This reporter will also work in tandem with others in the newsroom when lawsuits and coverage expands onto other beats - we know one person can't tackle it all.
Additionally, this reporter will be responsible for carving out coverage and zeroing in on Delaware's unique Chancery Court, where big business decisions happen every day and some of the nation's movers and shakers must frequent due to the state's rosy complexion for corporations. This coverage would provide not just important stories for Delaware, but also serve as a touchpoint for other USA TODAY Network following business happenings and lawsuits that affect their coverage areas. A willingness to collaborate is key.
In short, we want someone who writes for readers, identifying the stories that will interest a variety of audiences - and a reporter who understands that looks different day to day. This beat requires a reporter who can juggle multiple assignments and work on breaking news as well as short- and long-term enterprise. You must understand analytics and how to use that information to your advantage. And you must be ready and willing to spend time in the Wilmington courthouses, getting to know the players and showing up again and again to get the sourcing needed to tell these stories. This is not a remote position.
Requirements:
Bachelor's or master's in communications, journalism or an equivalent combination of education and experience.
At least 3 years of experience at a daily news organization.
Familiarity with digital storytelling tools and techniques, especially video for both on site and social.
Outstanding core journalism skills, including writing, spelling, grammar and AP style.
Must thrive in a competitive news market while possessing a collaborative spirit.
Deep understanding of journalism ethics.
Experience with social media, online metrics, third party tools and content management systems.
Ability to multi-task.
This role requires a valid driver's license, reliable transportation, and the minimum liability insurance required by state law.
Application Instructions We are eager to learn more about you and how you fit this role. When you apply, don't limit your upload to a resume; show us what you've done. To do so, put together a single document file that includes the following, in this order:
Your resume - one to two pages.
A cover letter that outlines how you would approach the job.
Links to 3-5 online samples of your work. Show us what you've produced or had a hand in that best reflects what you can do in your desired role.
It is important that these items be assembled in a single document and uploaded in PDF format. Completing these steps will ensure that your application receives the highest consideration.
#Newsgnt#LI-CB1
$47k-73k yearly est. 60d+ ago
Senior Medical Writer - FSP
Parexel 4.5
Reporter 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.
\#LI-LO1
\#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.
$76k-111k yearly est. 6d ago
Principal Medical Writer / Senior Medical Writer - US - FSP
Parexel 4.5
Reporter 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.
\#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.
$76k-111k yearly est. 41d ago
Senior Medical Writer- FSP
Parexel 4.5
Reporter 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.