Talent.com
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLCSalt Lake City, UT, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Principal Medical Writer

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

  • Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
  • Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
  • Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings
  • Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
  • Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
  • Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
  • Review statistical analysis plans and table / figure / listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
  • Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
  • Perform online clinical literature searches and comply with copyright requirements
  • Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
  • Mentor and lead less experienced medical writers on complex projects
  • Develop deep expertise on key topics in the industry and regulatory requirements
  • Work within budget specifications for assigned projects
  • Qualifications :

  • Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
  • 3-5 years of relevant experience in science, technical, or medical writing
  • Experience working in the biopharmaceutical, device, or contract research organization industry required
  • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and / or good publication practices strongly required
  • Experience writing relevant document types required
  • Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
  • Necessary Skills :

  • Strong presentation, proofreading, collaborative, and interpersonal skills
  • Strong project and time management skills
  • Strong proficiency in MS Office
  • Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information
  • Get to know Syneos Health

    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

    No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    http : / / www.syneoshealth.com

    Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

    serp_jobs.job_alerts.create_a_job

    Medical Writer • Salt Lake City, UT, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Travel Medical Technologist in West Jordan, UT

    Travel Medical Technologist in West Jordan, UT

    AlliedTravelCareersProvo, Utah, US
    serp_jobs.job_card.full_time +1
    AlliedTravelCareers is working with Infojini Healthcare to find a qualified Medical Technologist in West Jordan, Utah, 84081!. Medical Technologist travel Laboratory needed in West Jordan, Utah.Self...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Solutions Lead - Medical Technology

    Solutions Lead - Medical Technology

    VirtualVocationsProvo, Utah, United States
    serp_jobs.job_card.full_time
    A company is looking for a Solutions Lead - Med Tech.Key Responsibilities Conduct data analysis and generate insights by partnering with Sales Directors to design solutions using healthcare claim...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Medical Claim Review Nurse (RN)

    Medical Claim Review Nurse (RN)

    Molina HealthcareLehi, UT, United States
    serp_jobs.job_card.full_time
    Looking for a RN that has a current active unrestricted license.This a remote role and can sit anywhere within the United States. Work Schedule Monday to Friday - operation hours 6 AM to 6 PM (Team ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Telemedicine Physician

    Telemedicine Physician

    QuickMDGrantsville, UT, US
    serp_jobs.job_card.full_time
    QuickMD is a leading telemedicine provider, delivering high-quality virtual care across 44 states.Since our founding in 2019, we have helped more than 100,000 patients access essential medical trea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $1,822 to $2,037 per week in Saratoga Springs, UT

    Travel Nurse RN - Medical-Surgical - $1,822 to $2,037 per week in Saratoga Springs, UT

    TravelNurseSourceSaratoga Springs, UT, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Prime Time Healthcare to find a qualified Med / Surg RN in Saratoga Springs, Utah, 84043!. Now Hiring : RN Med Surg - Saratoga Springs, Utah.Contact us for Pay Informa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Medical Technologist in Layton, UT

    Travel Medical Technologist in Layton, UT

    AlliedTravelCareersProvo, Utah, US
    serp_jobs.job_card.full_time +1
    AlliedTravelCareers is working with Infojini Healthcare to find a qualified Medical Technologist in Layton, Utah, 84040!. Medical Technologist travel Laboratory needed in Layton, Utah.Self Assessmen...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Marine Interdiction Agent

    Marine Interdiction Agent

    U.S. Customs and Border ProtectionStockton, UT, United States
    serp_jobs.job_card.full_time
    Air and Marine Operations (AMO), a component of U.Customs and Border Protection (CBP) offers those with Merchant Mariner Credentials the exceptional opportunity of a career in law enforcement worki...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Owner Dentist

    Owner Dentist

    Professional Employment PDCTooele, UT, US
    serp_jobs.job_card.full_time
    Become an Owner Doctor with Platinum Dental Services - Empower Your Future!.Why Partner with Platinum Dental Services as an Owner?. Monthly Spear Study Club : We invest in your growth (paid for by us...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Clinical Research Coordinator 1

    Clinical Research Coordinator 1

    AMR ClinicalLayton, UT, United States
    serp_jobs.job_card.full_time
    The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies.The Clinical Research Coordinator must ensure compliance with federal regulations, stu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Speech Language Pathologist (SLP) - $1,820 to $3,413 per week in Tooele, UT

    Travel Speech Language Pathologist (SLP) - $1,820 to $3,413 per week in Tooele, UT

    AlliedTravelCareersTooele, UT, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with CompHealth to find a qualified Speech Language Pathologist (SLP) in Tooele, Utah, 84074!. Though your CompHealth recruiter will be your single point of contact, t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Occupational Medicine

    Occupational Medicine

    KPG Provider ServicesOrem, Utah, US
    serp_jobs.job_card.full_time +1
    Occupational Medicine physician employment in Utah : Inpatient Facility : Looking for an experienced Medical Director Occupational Medicine in the Orem, Utah area. Below you will find the Position ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Clinical Research Lead Assistant

    Clinical Research Lead Assistant

    VirtualVocationsProvo, Utah, United States
    serp_jobs.job_card.full_time
    A company is looking for a Site Management Associate I / Clinical Research Lead Assistant.Key Responsibilities Coordinate and schedule internal and external meetings and provide administrative su...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Case Management - $2,471 per week

    Travel Nurse RN - Case Management - $2,471 per week

    TNAA TotalMed Case ManagementLehi, UT, United States
    serp_jobs.job_card.full_time
    TNAA TotalMed Case Management is seeking a travel nurse RN Case Management for a travel nursing job in Lehi, Utah.Job Description & Requirements. We are seeking a Case Manager-Registered Nurse for a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Brighton Health Plan Solutions is hiring : Senior Proposal Writer in Salt Lake Ci

    Brighton Health Plan Solutions is hiring : Senior Proposal Writer in Salt Lake Ci

    MediabistroSalt Lake City, UT, United States
    serp_jobs.job_card.full_time
    Direct message the job poster from Brighton Health Plan Solutions.Lead Recruiter at Brighton Health Plan Solutions.Brighton Health Plan Solutions. Brighton Health Plan Solutions is seeking a strateg...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Echo Tech - $2,646 to $2,759 per week in West Valley City, UT

    Travel Echo Tech - $2,646 to $2,759 per week in West Valley City, UT

    AlliedTravelCareersProvo, Utah, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with Greenstaff Medical to find a qualified Echo Tech in West Valley City, Utah, 84120!.Why Choose Greenstaff Medical US?. Your Trusted Partner in Healthcare Staffing....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Speech Language Pathologist - $2,350 per week

    Travel Speech Language Pathologist - $2,350 per week

    CompHealth Inc.Tooele, UT, United States
    serp_jobs.job_card.full_time +1
    Speech Language Pathologist for a travel job in Tooele, Utah.Job Description & Requirements.Though your CompHealth recruiter will be your single point of contact, they are backed by dozens of speci...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Utah General Surgery opening near Salt Lake City

    Utah General Surgery opening near Salt Lake City

    Quorum HealthTooele, US
    serp_jobs.job_card.full_time +1
    Mountain West Medical Center is seeking a General Surgeon.Be busy right away / High Production Potential.Opportunity offers high quality of life. Anesthesia Coverage available 24 / 7.Supportive Admini...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Air Interdiction Agent

    Air Interdiction Agent

    U.S. Customs and Border ProtectionGranite, UT, United States
    serp_jobs.job_card.full_time
    Pilot CBP Air Interdiction Agent.Air and Marine Operations (AMO), a component of U.Customs and Border Protection (CBP), offers skilled Pilots interested in law enforcement an opportunity to work wi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days