Talent.com
Principal Medical Writer
Principal Medical WriterSyneos Health/ inVentiv Health Commercial LLC • Las Vegas, NV, United States
serp_jobs.error_messages.no_longer_accepting
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, 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 • Las Vegas, NV, United States

    Job_description.internal_linking.related_jobs
    Travel Nurse RN - Medical-Surgical - $2,254 per week in Elko, NV

    Travel Nurse RN - Medical-Surgical - $2,254 per week in Elko, NV

    TravelNurseSource • Henderson, Nevada, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Care Career to find a qualified Med / Surg RN in Elko, Nevada, 89801!.In general, M / S nurses provide care and treatment to ill, injured, and recovering adults.The me...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical Technologist - $1,809 to $2,005 per week in Winnemucca, NV

    Travel Medical Technologist - $1,809 to $2,005 per week in Winnemucca, NV

    LRS Healthcare • Henderson, Nevada, US
    serp_jobs.job_card.full_time
    Ready to start your next travel adventure? LRS Healthcare offers a full benefits package, 24 / 7 support, and a responsive, traveler-first culture. What are you waiting for? Apply today!.Valid license...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_hour • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Travel Medical Social Worker - $2,392 per week in Elko, NV

    Travel Medical Social Worker - $2,392 per week in Elko, NV

    AlliedTravelCareers • Henderson, Nevada, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with Windsor Healthcare Recruitment Group, Inc.Medical Social Worker in Elko, Nevada, 89801!. About Windsor Healthcare Recruitment Group, Inc.WHR isn’t just anot...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Home-Based Freelance Writer

    Home-Based Freelance Writer

    Outlier • Henderson, NV, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor and Delivery

    Travel Nurse RN - Labor and Delivery

    First Connect Health • Henderson, NV, US
    serp_jobs.job_card.full_time
    First Connect Health is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Henderson, Nevada.Job Description & Requirements. AWHONN Advanced Fetal Monitoring (AFM).NRP (Neo...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $1,930 per week in Fallon, NV

    Travel Nurse RN - Medical-Surgical - $1,930 per week in Fallon, NV

    TravelNurseSource • Henderson, Nevada, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with GetMed Staffing to find a qualified Med / Surg RN in Fallon, Nevada, 89406!.GetMed Staffing is searching for a strong MedSurg RN to assist our traveler-friendly clie...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Medical Assistant Primary Care

    Medical Assistant Primary Care

    Nevada Staffing • Henderson, NV, US
    serp_jobs.job_card.full_time
    A Medical Assistant has accountability for providing care to patients in an ambulatory clinic setting.This will involve caring for patients with acute and chronic needs. A Medical Assistant will be ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Physician (MD / DO) - Emergency Medicine - $300,000 to $350,000 per year in Las Vegas, NV

    Physician (MD / DO) - Emergency Medicine - $300,000 to $350,000 per year in Las Vegas, NV

    LocumJobsOnline • Henderson, Nevada, US
    serp_jobs.job_card.full_time +3
    LocumJobsOnline is working with Lancesoft Inc to find a qualified Emergency Medicine MD in Las Vegas, Nevada, 89109!.Pediatric Emergency Medicine Physician Opportunity 🚨👶.Pediatric Emergency Medi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Pediatrics - General / Other in Nevada

    Locum Physician (MD / DO) - Pediatrics - General / Other in Nevada

    LocumJobsNetwork • Henderson, US
    serp_jobs.job_card.full_time +1
    LocumJobsNetwork is working with Barton Associates to find a qualified Pediatrics MD in Nevada!.We are seeking a board-certified Pediatric Emergency Medicine physician for a locum tenens assignment...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical Technologist - $1,809 to $2,005 per week in Winnemucca, NV

    Travel Medical Technologist - $1,809 to $2,005 per week in Winnemucca, NV

    AlliedTravelCareers • Henderson, Nevada, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with LRS Healthcare to find a qualified Medical Technologist in Winnemucca, Nevada, 89445!. Ready to start your next travel adventure? LRS Healthcare offers a full ben...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_hour • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Principal Medical Writer - Submission Docs (2.5 / 2.7.2 / 2.7.3 / 2.7.4) - Oncology - Remote Based

    Principal Medical Writer - Submission Docs (2.5 / 2.7.2 / 2.7.3 / 2.7.4) - Oncology - Remote Based

    Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Principal Medical Writer - Submission Docs (2.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical,...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nuclear Medicine Tech - $1,966 to $2,166 per week in Reno, NV

    Travel Nuclear Medicine Tech - $1,966 to $2,166 per week in Reno, NV

    Titan Medical Group • Henderson, Nevada, US
    serp_jobs.job_card.full_time
    Travel - Nuclear Medicine Tech.BCLS / BLS - American Heart Association / NMTCB / ARRT(N).Titan Medical is looking for travelers to fill a Travel Nuclear Medicine Tech position for a 13 week assignment in...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • Las Vegas, NV, United States
    serp_jobs.job_card.full_time
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Proposal Writer

    Proposal Writer

    My Next Career Path Staffing • Las Vegas, Nevada, United States
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    A Proposal Writer (PW) analyzes solicitations to include Request for Proposals (RFPs), Request for Quotations (RFQs) to identify requirements for their assigned proposal sections, works with the Pr...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Locum Physician (MD / DO) - Emergency Medicine - $300 to $310 per hour in Henderson, NV

    Locum Physician (MD / DO) - Emergency Medicine - $300 to $310 per hour in Henderson, NV

    LocumJobsOnline • Henderson, Nevada, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with Lancesoft Inc to find a qualified Emergency Medicine MD in Henderson, Nevada, 89002!.Join a dedicated Pediatric Emergency Medicine team in.This growing pediatric eme...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Freelance Writer

    Freelance Writer

    Outlier • Henderson, NV, United States
    serp_jobs.job_card.full_time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Obstetrics and Gynecology - $200 to $250 per hour in Elko, NV

    Locum Physician (MD / DO) - Obstetrics and Gynecology - $200 to $250 per hour in Elko, NV

    LocumJobsNetwork • Henderson, US
    serp_jobs.job_card.full_time
    LocumJobsNetwork is working with Curative to find a qualified Obstetrics and Gynecology MD in Elko, Nevada, 89801!.OBGYN Physician - Locums Assignment in Nevada. Locums opportunity in Nevada with bl...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical Technologist - $1,809 to $2,005 per week in Winnemucca, NV

    Travel Medical Technologist - $1,809 to $2,005 per week in Winnemucca, NV

    AlliedTravelNetwork • Las Vegas, Nevada, US
    serp_jobs.job_card.full_time
    AlliedTravelNetwork is working with LRS Healthcare to find a qualified Medical Technologist in Winnemucca, Nevada, 89445!. Ready to start your next travel adventure? LRS Healthcare offers a full ben...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_hour • serp_jobs.job_card.promoted • serp_jobs.job_card.new