Principal Medical Writer- FSP
Medical writer job in Urban Honolulu, HI
**Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada.** Job Purpose: The Medical Writer, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality.
This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company's objectives.
Key Accountabilities:
Oversight of activities
- Write and edit clinical regulatory documents for clarity, and accuracy
according to Sponsor standards.
- Work with lead writer and project team to develop document messages
and data presentations within submission timelines to meet company objectives.
- Provide writing support for a wide range of documents, including but not
limited to investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs.
- Ensure that documents comply with International Conference on
Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices.
Collaborative relationships
- Collaborates effectively with lead writers and project teams to develop
and refine clinical regulatory documents that align with Sponsor standards, ICH guidelines, and Good Clinical Practices, ensuring clear and accurate communication of study data and objectives within submission timelines.
Compliance with Parexel standards
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and complies with Parexel processes,
ICH-GCPs and other applicable requirements
Skills:
- At least 4 years of writing experience in the pharmaceutical industry
- Experience with a variety of regulatory and clinical documents
- Experience in a matrix team environment
- Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Knowledge and Experience:
- Ability to write and edit complex material to ensure accuracy and clarity,
- Excellent written and oral communication skills and demonstrated problem-solving abilities
- Ability to handle multiple projects and short timelines
- Ability to work cooperatively with colleagues in a wide range of disciplines
Education:
- BA/BS or higher
\#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.
Reporter
Medical writer 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
Medical Value and Access Liaison - West US
Medical writer job in Urban Honolulu, HI
Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Medical Value Access Liaison - West US
Territory Coverage: West Coverage to include CA, NV, AK, HI, UT, AZ, ID, MT, WY
What you will do
Let's do this. Let's change the world. In this vital role you will develop programs, activities and relationships, both externally and internally to Amgen, in order to advance the value and clinical knowledge of our products to the payer community.
This is a field-based position within the Medical Value & Population Health team, within the Regional Medical Value Access Liaisons (MVAL) group in Scientific Affairs, reporting to a Director.
Geographic region for this position is within the U.S. business and majority regional accounts and select payer integrated IDNs as assigned.
Responsibilities:
* Provide Payer and Formulary Support through value and medical presentations that focus on therapeutic as well as economic outcomes and utilization aspects of products, and in clinical policy discussions such as evidence-based medicine, clinical guidelines and prior authorization in areas where Amgen has therapeutic expertise.
* Identify, develop, and maintain collaborative relationships with current and future Payer, Policy, IDN, and Health Economic and Outcomes Research opinion leaders through identifying speaker opportunities and concepts and letters of intent for investigator supported economics, humanistic outcome, and non-registration clinical studies to support Amgen's product messages within scope.
* Interact with key internal stakeholders to provide feedback on customer trends in interpreting and using value evidence, reimbursement and payer policy.
* Provide complex value-based technical information inclusive of medical education, health outcomes and Pharmacoeconomics information and models and research protocol opportunities to appropriate audiences.
* Represent Amgen Scientific Affairs to designated payer & select IDN accounts.
* Represent Amgen to designated thought leaders in health economics and outcomes research for Amgen Global Health Economics (GHE) and Amgen Center for Observational Research (CfOR).
* Foster scientific information exchange as it relates to reimbursement and coverage policy between the medical community and Amgen.
* Collect and report competitive intelligence within Amgen's competitive intelligence guidelines.
* Effectively manage internal relationships, budgets, and T and E within guidelines.
* Conduct all assigned duties within Amgen compliance guidelines.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Medical Value Access Liaison with these qualifications.
Basic Qualifications:
Doctorate degree & 2 years of Medical Affairs experience
OR
Master's degree & 6 years of Medical Affairs experience
OR
Bachelor's degree & 8 years of Medical Affairs experience
Preferred Qualifications:
* Pharm.D., Ph.D., M.D. or D.O.
* Five years Biotech industry experience working directly with US Payer Accounts
* CV, Metabolic, Inflammation, Bone, Neuro Oncology therapeutic area expertise
* Deep knowledge of managed markets, US Reimbursement Landscape, Pharmacoeconomics, Population Health, and other broad healthcare trends.
* Experience in Patient Access in US and / or global markets
* Project management experience within a biopharmaceutical company
* Strong advocacy, communication and team cohesion skills
* Critical thinking, analytical and project management skills
* Ability to lead and manage projects from concept to completion
* Strong interpersonal skills, negotiation skills, active listening, and relationship management skills
* Interface effectively with all levels, including senior management
* Ability to influence others while fostering a value-based environment of dedication and fairness
* Ability to understand, plan, and navigate in a matrix and, at times, ambiguous environment
* Strong verbal and written communication skills; ability to clearly and effectively present information
* Demonstrates creativity and foresight in anticipating and solving complex project issues
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
* A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
* A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
* Stock-based long-term incentives
* Award-winning time-off plans
* Flexible work models, including remote and hybrid work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
163,395.00 USD - 193,284.00 USD
Business Process Writer
Medical writer job in Hawaii
SAIC is currently seeking a Business Process Writer located in Camp Smith in Hawaii to support the USINDOPACOM to identify processes from system administration and network operations to create document and standard operating procedures (SOPs).
JOB DESCRIPTION:
Document J73 processes and procedures for supporting USINDOPACOM training events and exercises.
Document IT event support, IT service desk, logistics, network operations.
Research and develop improved business processes and procedures.
Conduct and participate in MS Teams meetings.
Conduct focus meetings to support process and procedure documentation.
Conduct staff coordination via email, MS Teams, written products.
Validate existing processes are clear and accurate.
Support development of business process analytics and performance measures.
SAIC accepts applications on an ongoing basis and there is no deadline.
SAIC is a premier Fortune 500 mission integrator focused on advancing the power of technology and innovation to serve and protect our world. Our robust portfolio of offerings across the defense, space, civilian and intelligence markets includes secure high-end solutions in mission IT, enterprise IT, engineering services and professional services. We integrate emerging technology, rapidly and securely, into mission critical operations that modernize and enable critical national imperatives.
We are approximately 24,000 strong; driven by mission, united by purpose, and inspired by opportunities. SAIC is an Equal Opportunity Employer. Headquartered in Reston, Virginia, SAIC has annual revenues of approximately $7.5 billion. For more information, visit saic.com. For ongoing news, please visit our newsroom.
REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's and two (2)+ years of related experience; additional four (4) years of experience accepted in lieu of degree.
Experience documenting processes and procedures (SOPs).
Experience holding focus groups to identify business processes.
Knowledge of IT system administration and network operations.
Demonstrated skill using MS Word for developing SOPs, MS Excel, PowerPoint, and MS Visio to develop presentations, processes, and procedures.
REQUIRED CLEARANCE:
Must have a current Active Secret Clearance with the ability to obtain a Top Secret/SCI Clearance.
Must have current US Citizenship.
Auto-ApplyAssignment Editor - Khnl
Medical writer 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.
Senior Medical Science Liaison
Medical writer job in Urban Honolulu, HI
**About Nuclear & Precision Health Solutions:** The Nuclear & Precision Health Solutions (NPHS) division is committed to improving the lives of patients by applying more than 40 years of experience and expertise in nuclear medicine and precision health. The business provides radiopharmaceutical development, manufacturing, preparation, market access, and business solutions across the care delivery continuum from origin to patient administration. As the only national source for both SPECT and PET radiopharmaceuticals with the largest network of 130 pharmacies and 30 cyclotron facilities, we can reach 95% of U.S. hospitals within three hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, so they can focus on their patients.
**What a Senior Medical Science Liaison contributes to Cardinal Health** :
The Senior Medical Science Liaison acts as a representative of the Nuclear & Precision Health Solutions (NPHS) medical affairs department to support Cardinal Health customers, the scientific development of radiopharmaceutical drug products, and medical education.
This role leverages internal product knowledge and medical and clinical subject matter expertise to develop activities that deliver highly credible, and fair/balanced scientific information to internal and external stakeholders. The individual will establish professional relationships with medical thought leaders including key opinion leaders (KOLs) to communicate and understand key relevant clinical and research insights and develop and deploy scientific and clinical education for healthcare professionals, patients and others.
This role joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs.
**Responsibilities:**
+ Collaborate across multiple functions and within a region to maximize theranostic knowledge and clinical strategies
+ Lead scientific strategy at medical congresses
+ Lead internal and external clinical education programs
+ Provide timely feedback/information on emerging clinical/scientific data and opportunities from literature and market insights to internal teams and stakeholders (strategy, business development, marketing)
+ Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider settings in both groups and one-on-one situations
+ Identify Key Opinion Leaders (KOLs) to establish and maintain scientific relationships; connect with KOLs in academic and community centers in multiple therapeutic areas focused on radiopharmaceuticals (oncology, neurology, cardiology)
+ Act as a technical resource to physicians, nuclear medicine technologists, and other healthcare providers using NPHS products
+ Act as primary liaison to investigators interested in developing and performing investigator-initiated research of NPHS products
+ Collaborate with NPHS Clinical Affairs to enhance patient enrollment in NPHS-sponsored clinical trials with site recommendations and maintain contact with investigators participating in ongoing studies
+ Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including any MSL presentations and Medical/Safety Review Committees
+ Provides pharmacovigilance support through collaboration with other internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying customer needs or knowledge gaps to ensure customers use our products safely and effectively
+ Participate in internal advisory boards to support product safety monitoring and medical affairs oversight
**Qualifications:**
+ 10+ years of experience as a Medical Science Liaison or in a similar clinical education role with customer facing experience
+ Radiopharmaceutical hands-on experience is required, i.e. Nuclear Medicine Technologist experience
+ Nuclear Medicine certification (NMT, CNMT) or MD/DO/PharmD/RN/PhD preferred
+ Bachelor's degree in a scientific field and/or medical discipline in applicable field highly preferred
+ Current working knowledge of US legal, regulatory, and compliance regulations & guidelines to industry interactions with healthcare professionals
+ Possess the ability to partner and maintain relationships within the medical community
+ Proven ability to work independently and in cross-functional teams and networks
+ Outstanding written and verbal presentation skills
+ Proficient knowledge of Microsoft Office
+ Strong business acumen, project management, analytical, communication and decision-making skills
+ Ability to thrive in a matrix organization and enjoy a problem-solving, fast-paced environment
+ Strong customer facing experience with ability to interact with all levels of internal and external customers
+ Ability to travel up to 20% when needed (primarily to scientific conferences, customer locations); can work remotely from home when not traveling
**What is expected of you and others at this level:**
+ Interacts with subordinates, peers, customers, and suppliers at various management levels
+ Interact with senior management
+ Independently lead Medical Affairs projects
+ Utilizes broad and deep knowledge to develop innovative new business practices, policies and procedures
+ Contributes to the development of department strategy
+ Works on or lead highly complex projects of large scope
+ Provides solutions which set precedent
+ Consults with management to determine project objectives with long-term implications
+ Acts as a mentor to less experienced colleagues
**Anticipated salary range:** $105,600-$167,265
**Bonus eligible:** Yes
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with my FlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 11/15/2025 *if interested in opportunity, please submit application as soon as possible.
_The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity._
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (***************************************************************************************************************************
Reporter
Medical writer 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
Budget and Grant Management Specialist
Medical writer 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
Auto-Apply