Sanofi is hiring : Associate Director-Principal Medical Writer in Omaha
MediabistroOmaha, NE, United Statesjob_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionJob Title : Associate Director-Principal Medical Writer Location : USA, Remote. Proximity to Cambridge / Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings About the Job The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead.As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole, and individual clinical studies. Our Team : Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. Main Responsibilities : More specifically the position holder, is responsible for the timely preparation and / or coordination, in English, of reports and / or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation. must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely. may need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff (e.g. for the preparation of tables, illustrations and appendices). in addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoring and / or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors.In addition, he / she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement. He / she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings.He / she contributes to training preparation and delivery, and provides support to the medical writing teams. Principal duties and responsibilities Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare or coordinate the preparation of clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare or coordinate the preparation of responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems / processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives, concerning content, processes and tools for the implementation of new / updated processes or IT solutions to bring efficiencies, time and / or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers. In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving. About You Knowledge and skills An experience as a Medical Writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and / or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills. Formal Education And / or Experience required Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance / methodology, basic statistics, and / or the regulatory environment. Knowledge and skill desirable but non-essential Specific knowledge of company-targeted therapeutic areas is strongly desirable. Why Choose Us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status
#J-18808-Ljbffr
serp_jobs.job_alerts.create_a_job
Is Associate Medical • Omaha, NE, United States
Job_description.internal_linking.related_jobs
Molina Healthcare Services (HCS) works with members, providers and multidisciplinary team members to assess, facilitate, plan and coordinate an integrated delivery of care across the continuum, inc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Amazon delivery partner opportunity – Earn $18.It's simple! Use your vehicle and smartphone to earn extra money delivering with a brand you trust.
With Amazon Flex, you only deliver when y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days Amazon delivery partner opportunity – Earn $18.It's simple! Use your vehicle and smartphone to earn extra money delivering with a brand you trust.
With Amazon Flex, you only deliver when y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days 
Part-Time (Hybrid) Medical Director Opportunity! Omaha John Galt / Lincoln, NE.Schedule - 10 Hours / Week (Flexible within M-F from 7 am to Noon).
The Physician / Medical Director serves at one or more ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Sysco is Now Hiring Local CDL-A Drivers in Omaha, NE!.Immediately Hiring CDL-A Drivers!.Earn Up to $100,000 per Year • - Comprehensive Benefits.
We offer our colleagues the opportunity to grow person...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 Amazon delivery partner opportunity – Earn $18.It's simple! Use your vehicle and smartphone to earn extra money delivering with a brand you trust.
With Amazon Flex, you only deliver when y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days Molina Healthcare Services (HCS) works with members, providers and multidisciplinary team members to assess, facilitate, plan and coordinate an integrated delivery of care across the continuum, inc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours 
Licensed Clinical Social Worker (LCSW).Wage : Between $95-$122 an hour.Licensed Clinical Social Worker — Are you ready to launch or expand your private practice? .
Headway is here to help you start ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 Amazon delivery partner opportunity – Earn $18.It's simple! Use your vehicle and smartphone to earn extra money delivering with a brand you trust.
With Amazon Flex, you only deliver when y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days Reporting to the Manager of Clinical Informatics for Analytics & Interfaces, the Associate Clinical Informatics Analyst is responsible for supporting application, hardware and software technical su...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours JOB DESCRIPTION Job SummaryProvides non-clinical administrative support to the care management function, and contributes to interdisciplinary team efforts supporting provision of integrated deliver...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours 
Assistant Director of Nursing Needed for Skilled Nursing Facility.This Jobot Job is hosted by : Mikayla Byington.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
JOB DESCRIPTION Job Summary Provides support for clinical member services review assessment processes.Responsible for verifying that services are medically necessary and align with established cl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour Director of Nursing Needed for Skilled Nursing Facility.This Jobot Job is hosted by : Mikayla Byington.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Sal...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days 
Medical Director OpportunityOmaha, NE more information on this Medical Director opening and others like it through Metropolis, a Provider Engagement Platform that connects you with organizations in...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Arial, sans-serif;"> Clinical Supervisor (...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days The Director, Clinical Operations is responsible for the clinical operations within the Clinical Contact Center team.Directs all Clinical Contact Center operations.
Implements direction and performa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours Candidates must be located in North East Ohio (Cuyahoga, Geauga, Lake, Lorain, Medina, Cleveland) and would require 80 -90% travel.
Provides support for community-based member advocacy activities.Se...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Supervisor - Medical
Molina HealthcareFremont, NE, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Amazon Flex Package Delivery Driver - Earn $18.00 - $24.50 / hr
Amazon FlexNeola, IA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Amazon Flex Delivery Driver - Earn $18.00 - $24.50 / hr
Amazon FlexMcClelland, IA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.new
Part-Time (Hybrid) Medical Director for OTP Clinic
BayMark Health ServicesOmaha, NE, USserp_jobs.job_card.part_time
serp_jobs.filters_job_card.quick_apply
- serp_jobs.job_card.promoted
Local CDL-A Driver - Earn Up to $100,000 / Hour + Great Benefits
SyscoWoodbine, IA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Amazon Package Delivery Driver - Earn $18.00 - $24.50 / hr
Amazon FlexSilver City, IA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Medical Supervisor
Molina HealthcareFremont, NE, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Licensed Clinical Social Worker
HeadwayPapillion, NE, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Amazon Delivery Driver - Flexible Shifts - Earn $18.00 - $24.50 / hr
Amazon FlexGlenwood, IA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Associate Data Analyst, Clinical Informatics
Molina HealthcareBellevue, NE, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Data Management / Medical
Molina HealthcareFremont, NE, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Assistant Director of Nursing
JobotMissouri Valley, IA, USserp_jobs.job_card.permanent
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Care Review Clinician (RN)...
Molina HealthcareFREMONT, NE, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director of Nursing
JobotWoodbine, IA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Physician / Medical Director / Nebraska / Permanent / Medical Director Opening, Omaha, Nebraska Job
ConfidentialOmaha, NE, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
BCBA - Up to 5K Sign on Bonus
Accel TherapiesSilver City, IA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Director, Clinical Operations
Molina HealthcareFremont, NE, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Community Medical
Molina HealthcareBellevue, NE, USserp_jobs.job_card.full_time