Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service.
**How you'll make an impact:**
+ Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department
+ Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties
+ Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle
+ Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams
+ Review and interpret study data analyses
+ Contribute to the generation of product life cycle plans (e.g., post-market surveillance).
**What you'll need (Required):**
+ Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria
+ Demonstrated track record in people management or equivalent work experience based on Edwards criteria
**What else we look for (Preferred):**
+ Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria
+ Medical writing or regulatory certification or equivalent work experience based on Edwards criteria
+ Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria
+ Experience working in a regulated industry or equivalent work experience based on Edwards criteria
+ Certification in related fields
+ Strong leadership in project and team management, including coaching and performance oversight.
+ Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines.
+ Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations.
+ Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed).
+ Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate.
+ Familiarity with coronary interventional and structural heart environments.
+ Proven ability to develop metrics demonstrating medical writing value to the business.
+ Ability to thrive in a fast-paced, dynamic environment with strict attention to detail.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $142,000 to $201,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**COVID Vaccination Requirement**
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
$142k-201k yearly 19d ago
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Reporter
American City Business Journals 4.6
Senior copywriter job in Urban Honolulu, HI
PBN reporters are tasked with consistently producing newsy, engaging daily online content for our website and daily email newsletters.
They are expected to break news by owning their beats, dictating day-to-day coverage and thriving on digging out source-driven exclusives. Their stories deliver intel that makes the jobs of local business owners and executives easier.
They balance the highest storytelling, reporting, and writing standards with ambitious traffic and engagement objectives.
They relentlessly develop sources and manage relationships with high-level executives and other community leaders.
They scoop competitors on every story of any significance, not only telling them what happened, but why and how.
#hiring #editorial #publishing #bizjournals
$49k-61k yearly est. 3d ago
Budget and Grant Management Specialist
Waianae Coast Comprehensive Health Center 4.3
Senior copywriter job in Waianae, HI
Under the direction of the Grants and Finance Manager, this position is responsible for performing the accounting functions of the Health Center's grant-funded programs, preparing and monitoring grant budgets, and assists in preparing and reporting financial statements conforming to generally accepted accounting principles and grant and regulatory requirements.
EDUCATION/EXPERIENCE:
High School Diploma or equivalent required
Bachelor's Degree in business, accounting, finance, or equivalent experience and/or at least five years of experience in a professional financial support position, preferable with responsibilities for accounting, budget, finance or a closely related field required
Demonstrated ability to understand oral and written documentation, write reports and procedures, and communicate effectively in a variety of situations required
Demonstrated ability to establish and maintain effective working relationships with internal and external organizations, groups, team members and individuals required
Experience in a not-for-profit organization preferred
Experience in a health care organization preferred
An Equal Employment Opportunity / Affirmative Action Employer
$49k-57k yearly est. Auto-Apply 60d+ ago
Managing Editor
ACBJ
Senior copywriter job in Urban Honolulu, HI
Run the operational side of the Pacific Business News newsroom, ensuring content assignments are made, story and production deadlines adhered to and editorial standards met.
Develop, oversee and edit stories.
Manage reporters and steer reporters toward beat-driven hard news breaks and scoops; work directly with reporters and manage them throughout the day on stories of all types.
Supervise and work with reporters to add context, perspective and voice to their content.
Strives to meet or exceed goals related to audience-engagement and growth via total visits, member visits, conversions, Stories that Work and other metrics that measure how content is resonating in the local business community.
Help reporters prioritize stories to pursue and sources to meet.
Manage the daily news meeting.
Oversee any awards content, special sections and editorial projects, as directed by the EIC. This could include the coordination of freelance photographers and/or contributing writers.
Report and write on a weekly basis.
Regularly participate in and attend Pacific Business News sponsored events.
Take on any other assignment made by manager(s).
Work cooperatively and collaboratively with all colleagues and sources.
About Gray Media: Gray Media, or Gray, is a multimedia company headquartered in Atlanta, Georgia, formally known as Gray Television, Inc. The company is the nation's largest owner of top-rated local television stations and digital assets serving 113 television markets that collectively reach approximately 36 percent of US television households. The portfolio includes 77 markets with the top-rated television station and 100 markets with the first and/or second-highest-rated television station, as well as the largest Telemundo Affiliate group with 43 markets totaling nearly 1.5 million Hispanic TV Households. The company also owns Gray Digital Media, a full-service digital agency offering national and local clients digital marketing strategies with the most advanced digital products and services. Gray's additional media properties include video production companies Raycom Sports, Tupelo Media Group, and PowerNation Studios, and studio production facilities Assembly Atlanta and Third Rail Studios.
We understand that life needs balance. That is why we offer our employees and eligible family members a comprehensive benefits package, including:
* Comprehensive Medical(Rx), Dental, and Vision Coverage
* Health Savings Account with Company contributions
* Flexible Spending Account
* Employer-paid life and disability benefits
* Paid parental leave benefits
* Adoption and Surrogacy Benefits
* 401(k) Plan, including matching and profit-sharing contributions
* Employee Assistance Program
* Voluntary benefits, including Hospital Indemnity, Critical Illness, Accident Insurance, and supplemental life insurance coverage
* Paid Time Off, including Relocation PTO
* Focus on Caring
Salary/Wage:
$50,000/year dependent on experience
Shift and Schedule:
Position requires working on weekends and other non-standard work hours.
_______________________
Job Summary/Description:
Hawaii News Now is looking for an aggressive assignment editor with solid news judgment who can handle multiple tasks simultaneously and adjust to a constantly changing environment. The ideal candidate must be calm in the chaos while evaluating resources, making good decisions, and communicating clearly and effectively under a deadline.
Duties and responsibilities include, but are not limited to:
* Plan and execute multiplatform news coverage
* Assist with the daily flow of news to the newsroom for appropriate coverage on-air and on the station's digital/ streaming platforms
* Manage logistics and resources
* Communicate clearly and effectively with broadcast and digital producers, field crews
* Gather meaningful news information from various sources; generate story ideas, discern credible news tips, and assign news crews
* Develop story ideas, confirm information
* Monitor email, and social media
* Monitor news sources to ensure news is being appropriately covered.
* Take in live feeds and coordinate interviews
* Create and publish content to digital and social media platforms as needed
Qualifications/Requirements:
* Bachelor's degree in broadcast journalism or related field, or equivalent training and/or experience
* At least two years working a major market newsroom assignment desk (or equivalent experience)
* Outstanding editorial skills, interpersonal communication skills, and time management skills
* Working knowledge of AP Style and social media platforms
* Scheduling flexibility is required
Preferred:
* Basic knowledge of video and still photography, and editing
* Experience with ENPS preferred
If you feel you're qualified and want to work with a great group of people go to *************************************** you may type in the job title, station call letters, or click on "apply now", upload your resume, cover letter and references
(Current employees that are interested in this position can apply through the Gray-TV UltiPro employee portal)
KHNL-TV/Gray Television Group, Inc. is a drug-free company
Additional Info:
Gray Television provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Gray Television complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. 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.
Gray Television expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Gray's employees to perform their job duties may result in discipline up to and including discharge.
$50k yearly 60d+ ago
Managing Editor
American City Business Journals 4.6
Senior copywriter job in Urban Honolulu, HI
Run the operational side of the Pacific Business News newsroom, ensuring content assignments are made, story and production deadlines adhered to and editorial standards met.
Develop, oversee and edit stories.
Manage reporters and steer reporters toward beat-driven hard news breaks and scoops; work directly with reporters and manage them throughout the day on stories of all types.
Supervise and work with reporters to add context, perspective and voice to their content.
Strives to meet or exceed goals related to audience-engagement and growth via total visits, member visits, conversions, Stories that Work and other metrics that measure how content is resonating in the local business community.
Help reporters prioritize stories to pursue and sources to meet.
Manage the daily news meeting.
Oversee any awards content, special sections and editorial projects, as directed by the EIC. This could include the coordination of freelance photographers and/or contributing writers.
Report and write on a weekly basis.
Regularly participate in and attend Pacific Business News sponsored events.
Take on any other assignment made by manager(s).
Work cooperatively and collaboratively with all colleagues and sources.
$78k-100k yearly est. 3d ago
Reporter
ACBJ
Senior copywriter job in Urban Honolulu, HI
PBN reporters are tasked with consistently producing newsy, engaging daily online content for our website and daily email newsletters.
They are expected to break news by owning their beats, dictating day-to-day coverage and thriving on digging out source-driven exclusives. Their stories deliver intel that makes the jobs of local business owners and executives easier.
They balance the highest storytelling, reporting, and writing standards with ambitious traffic and engagement objectives.
They relentlessly develop sources and manage relationships with high-level executives and other community leaders.
They scoop competitors on every story of any significance, not only telling them what happened, but why and how.
#hiring #editorial #publishing #bizjournals
$29k-45k yearly est. 3d ago
Senior Medical Writer- FSP
Parexel 4.5
Senior copywriter job in Urban Honolulu, HI
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.
$84k-113k yearly est. 17d ago
Assignment Editor - Khnl
Gray Media
Senior copywriter job in Urban Honolulu, HI
About Gray Television:
Gray Media, or Gray, is a multimedia company headquartered in Atlanta, Georgia, formally known as Gray Television, Inc. The company is the nation's largest owner of top-rated local television stations and digital assets serving 113 television markets that collectively reach approximately 36 percent of US television households. The portfolio includes 77 markets with the top-rated television station and 100 markets with the first and/or second-highest-rated television station, as well as the largest Telemundo Affiliate group with 43 markets totaling nearly 1.5 million Hispanic TV Households. The company also owns Gray Digital Media, a full-service digital agency offering national and local clients digital marketing strategies with the most advanced digital products and services. Gray's additional media properties include video production companies Raycom Sports, Tupelo Media Group, and PowerNation Studios, and studio production facilities Assembly Atlanta and Third Rail Studios.
We understand that life needs balance. That is why we offer our employees and eligible family members a comprehensive benefits package, including:
Comprehensive Medical(Rx), Dental, and Vision Coverage
Health Savings Account with Company contributions
Flexible Spending Account
Employer-paid life and disability benefits
Paid parental leave benefits
Adoption and Surrogacy Benefits
401(k) Plan, including matching and profit-sharing contributions
Employee Assistance Program
Voluntary benefits, including Hospital Indemnity, Critical Illness, Accident Insurance, and supplemental life insurance coverage
Paid Time Off, including Relocation PTO
Focus on Caring
Salary/Wage:
$50,000/year dependent on experience
Shift and Schedule:
Position requires working on weekends and other non-standard work hours.
_______________________
Job Summary/Description:
Hawaii News Now is looking for an aggressive assignment editor with solid news judgment who can handle multiple tasks simultaneously and adjust to a constantly changing environment. The ideal candidate must be calm in the chaos while evaluating resources, making good decisions, and communicating clearly and effectively under a deadline.
Duties and responsibilities include, but are not limited to:
- Plan and execute multiplatform news coverage
- Assist with the daily flow of news to the newsroom for appropriate coverage on-air and on the station's digital/ streaming platforms
- Manage logistics and resources
- Communicate clearly and effectively with broadcast and digital producers, field crews
- Gather meaningful news information from various sources; generate story ideas, discern credible news tips, and assign news crews
- Develop story ideas, confirm information
- Monitor email, and social media
- Monitor news sources to ensure news is being appropriately covered.
- Take in live feeds and coordinate interviews
- Create and publish content to digital and social media platforms as needed
Qualifications/Requirements:
- Bachelor's degree in broadcast journalism or related field, or equivalent training and/or experience
- At least two years working a major market newsroom assignment desk (or equivalent experience)
- Outstanding editorial skills, interpersonal communication skills, and time management skills
- Working knowledge of AP Style and social media platforms
- Scheduling flexibility is required
Preferred:
- Basic knowledge of video and still photography, and editing
- Experience with ENPS preferred
If you feel you're qualified and want to work with a great group of people go to *************************************** you may type in the job title, station call letters, or click on "apply now", upload your resume, cover letter and references
(Current employees that are interested in this position can apply through the Gray-TV UltiPro employee portal)
KHNL-TV/Gray Television Group, Inc. is a drug-free company
Additional Info:
Gray Television provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Gray Television complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. 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.
Gray Television expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Gray's employees to perform their job duties may result in discipline up to and including discharge.
$50k yearly 60d+ ago
Principal Medical Writer / Senior Medical Writer - US - FSP
Parexel 4.5
Senior copywriter job in Urban Honolulu, HI
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.