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.
The Peninsula Clarion in Kenai, Alaska, is seeking a full-time experienced reporter to cover local news and events in an area renowned for its spectacular scenery and rich cultural history. In this position, the successful candidate will lead community coverage. This role is ideal for a reporter who thrives on accountability journalism, enjoys fast-paced environments, and has a passion for informing civic dialogue.
This position includes:
* Reporting on community news, events and municipal government
* Breaking news and general assignment reporting
* Publishing stories to the web and once-weekly print edition
* Building relationships with key sources
* Taking photographs and contributing to the Peninsula Clarions growing digital and social platforms
Skills and attributes:
* At least two years of professional journalism experience
* A deep understanding of journalistic ethics and commitment to factual accuracy
* Proficiency in AP Style, basic photography, and CMS/web publishing tools
* Ability to file timely, clean copy and work both independently and collaboratively
* Interest in engaging readers across digital platforms, including newsletters and social media
About Kenai, Alaska:
Surrounded by spectacular scenery and wildlife, Kenai is located on the Kenai Peninsula where the world-famous Kenai River meets Cook Inlet.
Kenai is an outdoor enthusiast's playground, with world-class King Salmon fishing and natural recreation. Kenai industries include oil, natural gas, commercial fishing and tourism.
About us:
Located in the Kenai- Soldotna area, the Peninsula Clarion is one of Alaska's most recognized news publications.
Since 1970, it has shown a passion for community and award winning journalism, with a strong print and digital presence.
Please send your resume, cover letter and relevant story samples to:
Ashley Wadhwani-Smith
Editorial Director, Carpenter Media Group
***************************************
And cc:
Mary Kemmis
Group Publisher, Carpenter Media Group
*************************
Job Type: Full-time
Benefits:
* Dental insurance
* Health insurance
* Paid time off
* Professional development assistance
Ability to Relocate:
* Kenai, AK 99611: Relocate before starting work (Required)
Work Location: In person
Sound Publishing is an Equal Opportunity Employer and strongly supports diversity in the workplace. Visit our website to learn more about us! ************************
$36k-48k yearly est. Easy Apply 60d+ ago
Grant Specialist
Seldovia Village Tribe Ira
Senior copywriter job in Homer, AK
Come join our team at Seldovia Village Tribe (SVT)!
Hours: Full-time, 35 hour per week position.
Salary Range: $30 to $32 per hour, depending on experience
This position provides professional and administrative support, reviews, and evaluates grants for the Seldovia Village Tribe. The Grant Specialist will be responsible for completing grant proposals, agreements, and record-keeping in compliance with established guidelines and local, state, and federal laws and regulations.
What You'll Do:
Assist with grant proposals, agreements, pertinent attachments, and tracking and timely filing of program/performance reports to the funding agency.
Support the Grants Manager with tasks related to compliance monitoring throughout the grant cycle, generating grant documents, and ensuring grants comply with established administrative and financial policies and procedures.
Collaborate with Grants Manager and Program Managers to streamline grants process in early stages of planning and prioritization.
Organize project-specifc funding strategies. Research eligible grant funding opportunities.
Consult with appropriate Program Managers on grant research, determination of asset and resource needs, identify priorities, proposal development, and project management.
Participate in the reporting to funding sources. Work to assume responsibility for procedural reporting from the Grants Manager.
Create grant development resources for the organization and educate staff members about grants.
Support the Grants Manager to educate Program Managers on opportunities for developing new grant development initiatives and innovations.
Coordinate and participate in stakeholder meeting for new grant awards.
Other duties as assigned.
Be able to travel as needed (day trips) to other communities including to and from Homer / Seldovia by small airplane and sometimes by boat when airplanes are on weather hold. Travel is a day trip, but inclement weather may require an overnight stay.
What You'll Need:
Associate's Degree in related field, required. Will accept work equivalent in addition to work experience requirements.
2+ years related experience, required
Tribal experience, a plus
Must be able to successfully pass a pre-employment drug screen and a pre-employment background check including fingerprinting.
What You'll Get:
11 Paid Holidays per year
12 Days of Sick Leave per year
15 days (3 weeks) of Annual Leave per year (starting accrual, more days with more years of service)
FEHB (Federal Employees Health Benefits) - Health Insurance, a variety of plans to choose from. For full-time employees, we pay 100% of employees monthly health insurance premiums! And we pay 50% of the monthly premiums for your spouse and/or children. Insurance is effective the first day of the month after we receive your enrollment form.
Dental insurance, Vision insurance and long-term disability insurance available on the first of the month following 90 days of employment.
Group life insurance, minimum benefit is $50,000 and up to 2x your annual salary to a maximum of $250K after 90 days of employment.
Employer matching 401K, 5% match, effective January 1 or July 1, following one year of employment.
Wellness Incentive Program, up to $300 per calendar year for full-time employees, or $150 for part-time employees, effective after 90 days of employment. Examples of items that can be reimbursed are walking/running shoes, active wear, exercise equipment, gym membership, CSA food boxes and more!
About Us:
Seldovia Village Tribe (SVT) promotes the wellness of our people and communities through healthcare, social services, economic development, education, and cultural enrichment. SVT is a federally recognized Tribe that serves everyone - both Native and non-Native - in the communities of the South Kenai Peninsula, from Seldovia and beyond, including Homer and Anchor Point.
Contact Us:
If you have any questions, or would like further information, please contact Tara at ************ or email *************.
$30-32 hourly Easy Apply 49d ago
The Northern Light Reporter
University of Agriculture Faisalabad
Senior copywriter job in Anchorage, AK
The Northern Light is seeking a student worker for the position of Reporter. If you have experience or passion in the field we invite you to apply.
The Northern Light Reporters get to write stories for The Northern Light. They can write about news, features, arts and entertainment, opinion or sports.
Working for The Northern Light offers an unique opportunity for UAA students to learn about publishing and the news media. Staff have access to industry professionals, professional equipment, and chances to submit material for awards.
The Northern Light is UAA's student-run newspaper and explains issues that affect UAA while providing balanced coverage in representing students, staff, faculty and the greater community. The paper publishes stories online at ************************ and in print - distributed throughout the UAA campus and the Anchorage community.
To thrive in this role, applicants should possess excellent writing and research skills. Applicants should be interested in the news media and be willing to attend events, interview subjects and come up with interesting story ideas. Much of this work can be done remotely, so applicants must possess excellent communication and time management skills. Applicants should be team players who are good at giving and receiving constructive feedback.
Applicants can expect to work 8 - 12 hours per week.
Pay is $12.03 per hour.
Minimum Qualifications:
The ability to write quickly and meet deadlines is crucial for this position. Reports must pay close attention to details in writing to avoid publication of false or misleading information. Applicants must also be open to working collaboratively with editors on their written stories.
To be eligible for student employment, an applicant must: a. Be enrolled in the University of Alaska system with a minimum of six credit hours in the current semester of employment; or b. Have been enrolled the preceding semester for six or more credit hours and demonstrate plans to enroll for six or more credit hours in the next semester for employment between semesters; and c. Have at least a 2.0 cumulative grade point average (GPA), be in good academic standing, or approval from the MAU Senior Student Services officer or his/her designee. d. Students enrolled in non-traditional programs of study will be considered eligible for student employment with the approval of the Senior Student Services officer. e. An applicant must provide evidence of enrollment as outlined above to substantiate employment eligibility. f. Position reappointment is contingent upon successful progress toward degree completion and performance evaluation.
Position Details:
This position is open to undergraduate students only.
This is a part-time, 8 - 12 hours a week, student position paying $12.03/hour.
Applications will be reviewed on a rolling basis until a successful candidate is identified. Review of application materials will begin immediately. Search and selection procedures will be closed when a sufficient and viable number of qualified candidates have been identified
The University of Alaska (UA) is responsible for providing reasonable accommodations to individuals with disabilities throughout the applicant screening process. If you need assistance in completing this application or during any phase of the interview process, please contact UA Human Resources by phone at ************.
UA is an affirmative action/equal opportunity employer, educational institution and provider and prohibits illegal discrimination against any individual: *********************************
The successful applicant is required to complete a background check. Any offer of employment is contingent on the background check.
Your application for employment with the University of Alaska is subject to public disclosure under the Alaska Public Records Act.
If you have any questions regarding this position, please contact Micah Perino, Student Governance Fiscal Technician, at *******************
All employees at the University of Alaska are expected to uphold the highest standards of ethics and professionalism when conducting or engaged in university business.
*
Each university within the University of Alaska system publishes an Annual Security and Fire Safety Report which contains information regarding campus safety and security including topics such as: campus law enforcement authority; crime reporting policies; campus alerts (Timely Warnings and Emergency Notifications); fire safety policies and procedures; programs to prevent dating violence, domestic violence, sexual assault and stalking; the procedures the University will follow when one of these crimes is reported; and other matters of importance related to security on campus. The report also contains information about crime statistics for the three most recent calendar years concerning reported crimes that occurred on campus; in On-Campus Student Housing Facilities; in Noncampus buildings or property owned or controlled by the University or a recognized student organization; and on public property within, or immediately adjacent to and accessible from, the campus. The report also contains fire statistics for any fires occurring in an On-Campus Student Housing Facility during the three most recent calendar years.
Access to the reports is available at:
UAA: (Addresses Anchorage campus, Aviation Technology Complex, JBER - Elmendorf Extension, JBER - Richardson Extension, Kenai Peninsula College - Kachemak Bay campus, Kenai Peninsula College - Kenai River campus, Kodiak College, Kodiak High School Extension, Matanuska-Susitna College, Prince William Sound College, and Prince William Sound College - Cordova Extension) Online: ******************************************* Request a paper copy in person: UAA Police Department Office at Room 114 of Eugene Short Hall on the Anchorage campus / UAA Dean of Students Office at Room 122 of Rasmuson Hall on the Anchorage campus. Request a paper copy by mail: ************ or ********************* / ************ or uaa_*************************.
UAF: (Addresses Fairbanks Campus, Bristol Bay Campus, Chukchi Campus, Community and Technical College, Kasitsna Bay Campus, Seward Marine Center, Tok Campus, Kuskokwim Campus, and Northwest Campus) Online: ***************************************** Request a paper copy in person: UAF Office of Rights, Compliance and Accountability on the 3rd Floor of Constitution Hall. Request a paper copy by mail: ************ or *******************.
UAS: (Addresses the Juneau Auke Bay Campus, Juneau Technical Education Center, Sitka Campus, & Ketchikan Campus) Online: ********************************************************************** Request a paper copy in person: Hendrickson Building, Suite 202 on the Juneau campus. Request a paper copy by mail: ************ or emailing ********************.
$12 hourly Easy Apply 60d+ ago
Grant Writer
Searhc 4.6
Senior copywriter job in Juneau, AK
Pay Range:
Pay Range:$27.81 - $38.62 Responsible for identifying, defining, and developing funding opportunities to maintain or expand SEARHC programs as well as coordinating and supporting the development, writing, and submission of grant proposals.
SEARHC is a non-profit health consortium which serves the health interests of the residents of Southeast Alaska. We see our employees as our strongest assets. It is our priority to further their development and our organization by aiding in their professional advancement.
Working at SEARHC is more than a job, it's a fulfilling career. We offer generous benefits, including retirement, paid time off, paid parental leave, health insurance, dental, and vision benefits, life insurance and long and short-term disability, and more.
Key Essential Functions and Accountabilities of the Job
Initiates, develops, and submits high quality, timely, and well-researched funding proposals to support existing, expanded, and future SEARHC programs; maintain grant-tracking database.
Researches and identifies potential funding sources (private and government) to match with identified organizational and strategic priorities.
Coordinates new grant start-up process with finance department and grant managers; meets with grant managers to provide technical assistance as needed; assists with the production of internal and external reports for program planning as requested.
Education, Certifications, and Licenses Required
Bachelor's degree with course work including technical or other writing and program planning or 5 years' experience in grant writing, program development, and/or grant administration.
Experience Required
Two years' experience in grant proposal development with evidence of at least six funded proposals.
Excellent computer skills, including management of large, complex documents.
Two years' experience in community-based planning, conducting needs assessments, community organizing and/or facilitation.
Knowledge of
Government and private funding sources and submittal processes.
Grant narrative and budget development.
Skills in
Verbal and written communication including technical and creative writing.
Strong planning, time management and organizational skills.
Ability to
Work under pressure and timelines, with attention to detail, while successfully completing multiple projects
Interpret instructions and write complete, professional, and fundable proposals.
Required Certifications:
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
$27.8-38.6 hourly Auto-Apply 12d ago
Student Reporter
University of Alaska System 4.4
Senior copywriter job in Fairbanks, AK
Love storytelling, campus life, and chasing the next great scoop? Join The Sun Star as a staff reporter! You'll cover everything from student life and sports to features and Fairbanks culture-writing 3-4 stories a month that inform and inspire. Work closely with a passionate editorial team, sharpen your journalism skills, and take on exciting projects beyond the page. This is your chance to grow as a writer and make your voice heard.
The staff reporter is responsible for consistently writing and producing high-quality news articles for The Sun Star. This role involves contributing 3-4 articles each month on a range of topics, including campus news, student life, the outdoors, life in Fairbanks or North Pole, sports, and feature stories. In addition to writing, the reporter will conduct research, interview sources, and fact-check to ensure accuracy. Collaboration with the editorial team is essential to maintain The Sun Star's standards of fairness, accuracy, and quality. Reporters will also take on at least one additional task or project, to be determined and developed in coordination with the editorial team.
We're looking for a candidate with strong writing skills and the ability to produce clean, well-written copy on deadline. The ideal applicant can research and report on a variety of topics, writing in a clear, engaging style that resonates with readers. Familiarity with AP style and a commitment to accuracy are essential. Strong interviewing skills and the ability to build rapport with sources are also key. We value team players who can work independently when needed and thrive in a deadline-driven environment.
Minimum Qualifications:
Applicant must be enrolled as a UA student taking a minimum of 6 credits per semester with a minimum GPA of 2.0 or a newly enrolled student. Majoring in journalism or a related field is a plus. Experience in a college newspaper or other student-run publications is a plus. Strong computer skills and proficiency in using digital tools for research and reporting.
Position Details:
This position is located on the University of Alaska campus in Fairbanks.
This is a Student Assistant 2 Position, minimum starting pay is $14.96 per hour.
This is a pooled position and applications are reviewed as needed. Submission of an application does not guarantee review or a job offer.
️If you have any questions regarding this position, please contact Ashley Lindsoe, Signers' Business Office Human Resources Manager, at ******************** or ************.
The University of Alaska (UA) is responsible for providing reasonable accommodations to individuals with disabilities throughout the applicant screening process. If you need assistance in completing this application or during any phase of the interview process, please contact UA Human Resources by phone at ************.
The University of Alaska (*************** is an Equal Opportunity/Equal Access Employer and Educational Institution. The University is committed to a policy of non-discrimination (********************************* against individuals on the basis of any legally protected status.
The successful applicant is required to complete a background check. Any offer of employment is contingent on the background check.
Your application for employment with the University of Alaska is subject to public disclosure under the Alaska Public Records Act.
All employees at the University of Alaska are expected to uphold the highest standards of ethics and professionalism when conducting or engaged in university business.
* Each university within the University of Alaska system publishes an Annual Security and Fire Safety Report which contains information regarding campus safety and security including topics such as: campus law enforcement authority; crime reporting policies; campus alerts (Timely Warnings and Emergency Notifications); fire safety policies and procedures; programs to prevent dating violence, domestic violence, sexual assault and stalking; the procedures the University will follow when one of these crimes is reported; and other matters of importance related to security on campus. The report also contains information about crime statistics for the three most recent calendar years concerning reported crimes that occurred on campus; in On-Campus Student Housing Facilities; in Noncampus buildings or property owned or controlled by the University or a recognized student organization; and on public property within, or immediately adjacent to and accessible from, the campus. The report also contains fire statistics for any fires occurring in an On-Campus Student Housing Facility during the three most recent calendar years.
Access to the reports is available at:
UAA: (Addresses Anchorage campus, Aviation Technology Complex, JBER - Elmendorf Extension, JBER - Richardson Extension, Kenai Peninsula College - Kachemak Bay campus, Kenai Peninsula College - Kenai River campus, Kodiak College, Kodiak High School Extension, Matanuska-Susitna College, Prince William Sound College, and Prince William Sound College - Cordova Extension) Online: ******************************************* Request a paper copy in person: UAA Police Department Office at Room 114 of Eugene Short Hall on the Anchorage campus / UAA Dean of Students Office at Room 122 of Rasmuson Hall on the Anchorage campus. Request a paper copy by mail: ************ or ********************* / ************ or uaa_*************************.
UAF: (Addresses Fairbanks Campus, Bristol Bay Campus, Chukchi Campus, Community and Technical College, Kasitsna Bay Campus, Seward Marine Center, Tok Campus, Kuskokwim Campus, and Northwest Campus) Online: ***************************************** Request a paper copy in person: UAF Office of Rights, Compliance and Accountability on the 3rd Floor of Constitution Hall. Request a paper copy by mail: ************ or *******************.
UAS: (Addresses the Juneau Auke Bay Campus, Juneau Technical Education Center, Sitka Campus, & Ketchikan Campus) Online: ********************************************************************** Request a paper copy in person: Hendrickson Building, Suite 202 on the Juneau campus. Request a paper copy by mail: ************ or emailing ********************.
$15 hourly Easy Apply 60d+ ago
Senior Medical Writer- FSP
Parexel 4.5
Senior copywriter job in Juneau, AK
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.
$79k-103k yearly est. 17d ago
Senior News Reporter/Producer
University of Agriculture Faisalabad
Senior copywriter job in Fairbanks, AK
KUAC is hiring a Senior News Reporter/Producer. The position is part-time, benefited with 20 hours of week producing news for local, regional and statewide newscasts for daily delivery on KUAC FM and posting to the KUAC website. A Bachelor's degree in journalism, communications, media or related field and three years of professional newsroom experience, or an equivalent combination of training and experience is required. The KUAC News Reporter/Producer must maintain a high level of ethical, editorial, artistic and technical standards for broadcast and website news content. Must be able to work with news staff to develop story ideas, track issues and events and be able to meet deadlines and additionally work closely with other news producers/reporters.
We are seeking a skilled professional with at least three years of demonstrated experience in producing newscasts, feature stories, and interviews for radio. The ideal candidate will have a strong understanding of journalistic practices and media ethics, as well as excellent verbal and written communication skills. Experience in research, news gathering, fact-checking, and writing news stories for radio is essential. If you have a passion for radio journalism and a proven track record of success, we encourage you to apply.
Minimum Qualifications:
Bachelor's degree in journalism, communications, media or related field, and three years related professional experience, or an equivalent combination of training and experience.
Position Details:
This position is located on the University of Alaska campus in Fairbanks, and flexible on-site/hybrid work arrangements may be considered in accordance with UA regulations. This is a part-time, term-funded, non-exempt staff position complete with both a competitive salary and full employee benefits package. UA provides a generous compensation package that includes retirement options, annual leave, 12 paid holidays per year, tuition waivers for employees and family members, and affordable medical, dental and vision care coverage. New hires will be placed on the UA Staff Salary Schedule, Grade 79, based on education and experience.
Applications will be accepted for review on October 4th, 2024, to ensure consideration, please apply by 11:55 PM, Alaska Standard Time on October 3rd, 2024.
This position is a term-funded position and is reviewed annually for contract renewal at the University's discretion.
*To be eligible for this position, applicants must be legally authorized to work in the United States without restriction. Applicants who now or may in the future require visa sponsorship to work in the United States are not eligible.
The University of Alaska (UA) is responsible for providing reasonable accommodations to individuals with disabilities throughout the applicant screening process. If you need assistance in completing this application or during any phase of the interview process, please contact UA Human Resources by phone at ************.
UA is an affirmative action/equal opportunity employer, educational institution and provider and prohibits illegal discrimination against any individual: *********************************
The successful applicant is required to complete a background check. Any offer of employment is contingent on the background check.
Your application for employment with the University of Alaska is subject to public disclosure under the Alaska Public Records Act.
If you have any questions regarding this position, please contact Ashley Lindsoe, Signers' Business Office Human Resources Manager, at ******************** or ************.
All employees at the University of Alaska are expected to uphold the highest standards of ethics and professionalism when conducting or engaged in university business.
*
Each university within the University of Alaska system publishes an Annual Security and Fire Safety Report which contains information regarding campus safety and security including topics such as: campus law enforcement authority; crime reporting policies; campus alerts (Timely Warnings and Emergency Notifications); fire safety policies and procedures; programs to prevent dating violence, domestic violence, sexual assault and stalking; the procedures the University will follow when one of these crimes is reported; and other matters of importance related to security on campus. The report also contains information about crime statistics for the three most recent calendar years concerning reported crimes that occurred on campus; in On-Campus Student Housing Facilities; in Noncampus buildings or property owned or controlled by the University or a recognized student organization; and on public property within, or immediately adjacent to and accessible from, the campus. The report also contains fire statistics for any fires occurring in an On-Campus Student Housing Facility during the three most recent calendar years.
Access to the reports is available at:
UAA: (Addresses Anchorage campus, Aviation Technology Complex, JBER - Elmendorf Extension, JBER - Richardson Extension, Kenai Peninsula College - Kachemak Bay campus, Kenai Peninsula College - Kenai River campus, Kodiak College, Kodiak High School Extension, Matanuska-Susitna College, Prince William Sound College, and Prince William Sound College - Cordova Extension) Online: ******************************************* Request a paper copy in person: UAA Police Department Office at Room 114 of Eugene Short Hall on the Anchorage campus / UAA Dean of Students Office at Room 122 of Rasmuson Hall on the Anchorage campus. Request a paper copy by mail: ************ or ********************* / ************ or uaa_*************************.
UAF: (Addresses Fairbanks Campus, Bristol Bay Campus, Chukchi Campus, Community and Technical College, Kasitsna Bay Campus, Seward Marine Center, Tok Campus, Kuskokwim Campus, and Northwest Campus) Online: ***************************************** Request a paper copy in person: UAF Office of Rights, Compliance and Accountability on the 3rd Floor of Constitution Hall. Request a paper copy by mail: ************ or *******************.
UAS: (Addresses the Juneau Auke Bay Campus, Juneau Technical Education Center, Sitka Campus, & Ketchikan Campus) Online: ********************************************************************** Request a paper copy in person: Hendrickson Building, Suite 202 on the Juneau campus. Request a paper copy by mail: ************ or emailing ********************.
$24k-35k yearly est. Easy Apply 60d+ ago
Principal Medical Writer / Senior Medical Writer - US - FSP
Parexel 4.5
Senior copywriter job in Juneau, AK
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.