Job Closed

This listing is no longer active.

Senior Strategic Medical Writer

Medical writerMedical writerFull TimeRemoteSeniorTeam 10,001+Since 2013H1B SponsorCompany SiteLinkedIn

Location

Illinois

Posted

18 days ago

Salary

$96.5K - $183.5K / year

Seniority

Senior

Bachelor Degree4 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Strategic Medical Writer

AbbVie

• Prepares clinical and regulatory documents needed for the development of AbbVie drugs and/or devices. • Functions with a moderate degree of autonomy on draft materials, but relies on review by subject matter experts and more senior writers for verification. • Develops knowledge and understanding of submission strategies. • Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory projects. • Arranges and conducts review meetings with the team. • Produces and maintains clinical and regulatory documents focusing on quality and compliance and ensures delivery within project timelines. • Develops understanding of project management concepts and accepts greater responsibility for driving submission objectives. • Develops knowledge of US and international regulations, requirements, and guidelines pertaining to the preparation of regulatory documentation. • Understands and uses guidance associated with preparation of regulatory documentation. • Participates in execution of tactical process improvements. • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. • Works closely with leadership and R&D Quality Assurance to address inquiries and draft responses, supporting an inspection-ready approach.

Job Requirements

  • A minimum of 4+ years of bio-pharmaceutical industry experience in global pharma, biotech, life science, or healthcare authority delivering medicines/therapies to a broad market across various therapeutic areas.
  • Bachelor's Degree or higher required; scientific discipline preferred.
  • Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
  • Proficient in assimilating and analyzing complex data.
  • Experience writing and editing clinical and regulatory documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements.
  • Familiarity with industry standards like CONSORT and PRISMA guidelines.
  • EU and US device writing experience is a plus.
  • Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors
  • Excellent writing skills.
  • Effectively communicates complex scientific and medical information to various stakeholders.
  • Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams.
  • Strong organizational, time management, and problem-solving skills.

Benefits

  • paid time off (vacation, holidays, sick)
  • medical/dental/vision insurance
  • 401(k) to eligible employees
  • long-term incentive programs

Related Categories

Related Job Pages

More Medical writer Jobs

Cleveland Clinic logo

Clinical Documentation Specialist – I

Cleveland Clinic

The not-for-profit Cleveland Clinic was established in 1921 by four prominent doctors and provides a unique combination of clinical and medical care with academ

Medical writer18 days ago

• Provide education to providers and clinicians to ensure accurate documentation • Review for correct DRG, APC and HCC assignment • Conduct reviews of medical records for patients in outpatient settings • Query providers and medical team members to clarify clinical documentation

Ohio
Job Closed

Document Review Specialist

J. J. Keller & Associates, Inc.

J. J. Keller & Associates, Inc. is a North American organization providing innovative safety and regulatory compliance guidance and solutions to organizations across the U. S. and Canada. For over 70 years, organizations of all sizes have relied on J. J. Keller to help them create safe work environments for their employees and comply with ever-changing regulations.

Medical writer18 days ago

Role Description J. J. Keller has a REMOTE - Document Review Specialist opening in one of our fastest growing departments called Managed Services. This department is comprised of fleet and regulatory compliance experts who clients rely on to off-load the time consuming / complex tasks of managing driver safety and vehicle compliance. As a Document Review Specialist you will be responsible for auditing various documents on behalf of our clients in a metric driven environment. This position will also be responsible for translating documents from Canadian French to English. Job Responsibilities - Audits driver qualification documents and drug & alcohol information for clients. - Identifies discrepancies, checks systems for pertinent information, and enters information into applicable systems. - Works with Client Service Specialists to obtain and/or validate client information. Updates information in all applicable systems. - Maintains knowledge of the applicable local, state, and federal regulations that pertain to our service offerings. - Maintains confidentiality of client information under the FCRA, HIPAA, and other regulatory entities. Adheres to the department's data security policies pertaining to Personal Identification Information. Qualifications - Fluency in speaking, writing and reading French, Canadian French a plus. - High School Graduate or General Education Degree (GED). - 1+ years of experience in a general office setting. - In lieu, will consider a combination of experience and post-secondary education. - Experience in highly regulated industry a plus or ability to learn complex regulatory standards. - Must be proficient in the use of a PC and have the ability to navigate between multiple screens and computer programs. - Strong organizational skills and attention to detail. Requirements - Work is performed primarily in a standard office environment. - Work involves operation of personal computer equipment for extended periods of time. Benefits - $20 - $22/hr. - 17 days of PTO + 8 Paid Company Holidays + 1 Paid Floating Holiday - Annual Reviews + Merit Increases + Quarterly Bonus Program - New Hire On-the-Job Training - Medical + Dental + Vision Insurance - 401(k) with Employer Match + Company-funded Profit Sharing

United States
$20 - $22 / hour

Clinical Documentation Specialist

Singing River Health System

Singing River Health System is a community-focused healthcare provider serving the Mississippi Gulf Coast with hospitals in Pascagoula, Ocean Springs, and Gulfp

Medical writer18 days ago

Role Description The Clinical Documentation Specialist improves the overall quality and completeness of clinical documentation; facilitates modifications to clinical documentation through extensive interaction with physicians, nursing staff, other patient caregivers, and coding staff to ensure that documentation reflects the complexity and severity of illness for a complete and accurate level of service rendered to patients. - Analyzes the clinical status of patients, current treatment plans, and past medical history to identify potential gaps in clinical documentation. - Educates and serves as a clinical liaison to nursing staff and other clinicians on compliant documentation and accurate coding. - Reconciles DRG differences between the Coding staff and Clinical Documentation Specialist. - Monitors activities to ensure that all clinical documentation is in compliance with State and Federal payer regulations. DISCLAIMER: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this intends to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks performed as assigned. Qualifications - High School graduate or equivalent required. - If Registered Nurse, must be a graduate from NLN School of Nursing; Bachelor of Science in Nursing required. Requirements - If Registered Nurse (RN), must hold current applicable license to practice in Mississippi. Current Mississippi RN license preferred. - If not a Registered Nurse, must be certified by the American Health Information Management Association (AHIMA) or American Academy of Professional Coders (AAPC) as a: - Registered Health Information Administrator - Registered Health Information Technician - Certified Code Specialist - Certified Inpatient Coder - Must complete all requirements (including continuing education) to maintain certification. - CCDS preferred. - Must have de-escalation training completed by the end of position orientation (90 days); must have appropriate level of de-escalation training. - A Registered Nurse must have a minimum of two (2) years’ nursing experience in an acute-care facility. - Coders must have a minimum of two (2) years’ experience in ICD-9 CM and experience utilizing ICD-10 CM and ICD-10 PCS in an inpatient setting. - Must have working knowledge of the AHA Coding Clinic. - An understanding of the MS-DRG payment system is required. - An understanding of APR-DRG’s preferred. Benefits - Work is moderately active: involves sitting with frequent requirements to move about the office, move about the facility, and to travel to another facility within the SRHS service area. - Work involves exerting a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects, including the human body. - Work involves using many physical motions in performing daily work activities; subject to exposure of body fluids, sputum and tissues, which may carry the hazard of infectious disease. - Work involves using repetitive motions: substantial movements of the wrists, hands, and or fingers while operating standard office equipment such as computer keyboard. - Must be able to be active for extended periods of time without experiencing undue fatigue. - Must be able to work schedules assigned with the understanding that changes may be instituted according to the needs of the hospital for off days, shifts or weekends. Mental Demands - Must demonstrate keen mental faculties/assessment and decision making abilities. - Must demonstrate superior communication/speaking/enunciation skills to receive and give information in person and by telephone. - Must demonstrate strong written and verbal communication skills. - Must possess emotional stability conducive to dealing with high stress levels. - Must demonstrate ability to work under pressure and meet deadlines. - Attention to detail and the ability to multi-task in complex situations is required. - Must have the ability to maintain collaborative and respectable working relationships throughout SRHS and other organizations. Special Demands - Must possess superior customer service skills and professional etiquette. - Must possess proficient knowledge and ability to use a computer (must be keyboard proficient) and other office technology (i.e., telephone, fax, etc.), MS Outlook and Word. - Job requires traveling throughout the SRHS service area – with the employee providing his/her own transportation. - Work requires the ability to function independently, adapt to workload demands, set priorities, and understand and set goals. - Must possess highly developed organizational, planning and management writing skills. - Must understand the fundamentals of automated data processing, and be able to quickly gain a detailed understanding of complex computerized and non-computerized information.

Alabama + 8 moreAll locations: Alabama | Florida | Georgia | Louisiana | Mississippi | North Carolina | South Carolina | Tennessee | Texas
Genworth logo

Associate Claims Clinical Specialist

Genworth

At Genworth, we empower families to navigate the aging journey with confidence. We are compassionate, experienced allies for those navigating care with guidance, products, and services that meet families where they are. Further, we are the spouses, children, siblings, friends, and neighbors of those that need care—and we bring those experiences with us to work in serving our millions of policyholders each day. We apply that same compassion and empathy as we work with each other and our local communities. Genworth values all perspectives, characteristics, and experiences so that employees can bring their full, authentic selves to work to help each other and our company succeed. We celebrate our diversity and understand that being intentional about inclusion is the only way to create a sense of belonging for all associates. We also invest in the vitality of our local communities through grants from the Genworth Foundation, event sponsorships, and employee volunteerism. Our four values guide our strategy, our decisions, and our interactions: Make it human. Make it about others. Make it happen. Make it better.

Medical writer18 days ago
Full TimeRemoteTeam 201-500

Role Description The position of Associate Claims Clinical Specialist plays a leading role in the insured or member’s assessment process. We provide services to a variety of clients, all that require your deep knowledge of long-term care needs of an aging or chronically ill population. You will be part of a remote team of clinicians that spend their days reviewing clinical assessments completed by field assessors and writing Plans of Care for Long Term Care Insurance and other government sponsored insurance plans. Some days will be spent reaching out to claimants or members, their families, or facilities to discuss updates to their health and develop a plan of care. As our client list and capabilities grow, our opportunities also grow. This position uses your eldercare expertise and excellent communication skills to assure that the company serves our clients with the highest degree of quality, respect, and customer service. The successful candidate must be caring and empathetic with claimants, members, and their families. What you will be doing - Reviewing clinical assessments completed by field assessors to determine chronic illness status and develop a plan of care with supporting written documentation. - Collaborate with field assessors and facility staff via phone to determine if further information is needed on a claimant or member’s health status. - Call claimants, family members or facility staff to update records on their present health status and provide a new plan of care, as well as handle telephonic assessments. - Work with new clients to develop processes that meet their insureds’ needs. Qualifications - RN with a current license residing in a Nursing License Compact state with licensure in their residential state and a Nursing Compact License. - A minimum of 3 years of professional clinical experience in case management, home care, or a rehabilitation setting, preferably with a geriatric population. - Strong knowledge of Microsoft applications to include Outlook and Word. Proficient with workflow management tools and CRM. - Ability to data input into a digital platform while discussing care needs with a claimant or member. - Ability to handle inbound and outbound calls with claimants, family members, facilities and agencies. - Excellent communication skills, both oral and written, with a customer service focused attitude to build rapport and relationships. - Ability to meet daily tracked standards in both production and quality. - Excellent computer, data input and technical skills including working with multiple screens. - Demonstrate technical and professional expertise through problem resolution, while maintaining composure. - Robust critical thinking capabilities, coupled with the ability for independent decision making. - Strong multi-tasking, time management and follow-up skills to complete tasks in time sensitive manner. - Ability to independently resolve service issues and follow escalation protocol on issues. - Ability to make positive impressions over the phone and build rapport with clients, despite conversations that can be difficult or emotion filled. - Ability to work remotely in a quiet environment with strong, reliable internet while maintaining production levels. Requirements - Nice to have: BSN or equivalent. - Knowledge of Long-Term Care settings and residents. - Previous experience with Long Term Care, Medicare, or Medicaid Assessments. - Telephonic case management experience. - Bilingual. Benefits - Competitive Compensation & Total Rewards Incentives. - Comprehensive Healthcare Coverage. - Multiple 401(k) Savings Plan Options. - Auto Enrollment in Employer-Directed Retirement Account Feature (100% employer-funded!). - Generous Paid Time Off – Including 12 Paid Holidays, Volunteer Time Off and Paid Family Leave. - Disability, Life, and Long-Term Care Insurance. - Tuition Reimbursement, Student Loan Repayment and Training & Certification Support. - Wellness support including gym membership reimbursement and Employee Assistance Program resources (work/life support, financial & legal management). - Caregiver and Mental Health Support Services.

United States