Talent.com
Principal Medical Writer
Principal Medical WriterSyneos Health/ inVentiv Health Commercial LLC • Seattle, WA, United States
serp_jobs.error_messages.no_longer_accepting
Principal Medical Writer

Principal Medical Writer

Syneos Health / inVentiv Health Commercial LLC • Seattle, WA, 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 • Seattle, WA, United States

    Job_description.internal_linking.related_jobs
    Travel Medical Technologist - $1,942 to $2,153 per week in Spokane, WA

    Travel Medical Technologist - $1,942 to $2,153 per week in Spokane, WA

    LRS Healthcare • Tacoma, Washington, 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_variable_days • serp_jobs.job_card.promoted
    Nonclinical Writer

    Nonclinical Writer

    MMS • Seattle, WA, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Travel CT Technologist

    Travel CT Technologist

    Rang Healthcare • Everett, WA, US
    serp_jobs.job_card.permanent
    Rang Healthcare is seeking a travel CT Technologist for a travel job in Everett, Washington.Job Description & Requirements. Perm candidates of any OTHER providence facility ( NON SWEDISH ) are e...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel CT Tech - $2,383 to $2,583 per week in Everett, WA

    Travel CT Tech - $2,383 to $2,583 per week in Everett, WA

    Titan Medical Group • Everett, WA, US
    serp_jobs.job_card.full_time
    ARRT(CT) / BCLS / BLS - American Heart Association.Titan Medical is looking for travelers to fill a Travel CT Technologist position for a 13 week assignment in Everett, WA! Call Titan for additional de...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine in Chewelah, WA

    Locum Physician (MD / DO) - Emergency Medicine in Chewelah, WA

    LocumJobsNetwork • Tacoma, US
    serp_jobs.job_card.full_time
    LocumJobsNetwork is working with Weatherby Healthcare to find a qualified Emergency Medicine MD in Chewelah, Washington, 99109!. If this opportunity sounds right for you, give us a call today to spe...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel CT Tech - $2,503 to $2,703 per week in Everett, WA

    Travel CT Tech - $2,503 to $2,703 per week in Everett, WA

    Titan Medical Group • Everett, WA, US
    serp_jobs.job_card.full_time
    ARRT(CT) / BCLS / BLS - American Heart Association.Titan Medical is looking for travelers to fill a Travel CT Technologist position for a 13 week assignment in Everett, WA! Call Titan for additional de...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical Assistant (MA) in Edmonds, WA

    Travel Medical Assistant (MA) in Edmonds, WA

    AlliedTravelCareers • Tacoma, Washington, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with TechLink Systems, Inc.Medical Assistant in Edmonds, Washington, 98026!.Location (Onsite, Remote, or Hybrid?) : Edmonds, WA (ONSITE). Working Hours : Day 4x10-Hour ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • Seattle, WA, United States
    serp_jobs.job_card.full_time
    Principal Medical Writer - Regulatory Submission Documents.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate uni...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    RN Fellow - Pre Post ESU Surgery Recovery, March 2026 Cohort

    RN Fellow - Pre Post ESU Surgery Recovery, March 2026 Cohort

    Providence Health and Services • Everett, WA, US
    serp_jobs.job_card.full_time
    Providence is calling for applications for our.March 2026 RN Pre Post ESU Surgery Recovery Fellowship.An RN Fellow at Providence St Joseph Health will experience a guided transition into their new ...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

    LanceSoft • Everett, WA, US
    serp_jobs.job_card.permanent
    LanceSoft is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Everett, Washington.Job Description & Requirements. Years of Experience Required : 2 years.Certs Required : AC...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Medical Assistant (MA) - $23 to $29 per hour in Mill Creek, WA

    Travel Medical Assistant (MA) - $23 to $29 per hour in Mill Creek, WA

    AlliedTravelCareers • Mill Creek, WA, US
    serp_jobs.job_card.full_time +1
    AlliedTravelCareers is working with Pride Health to find a qualified Medical Assistant in Mill Creek, Washington, 98012!. REQUIRED : Please provide detailed answers to the below questions : .What are t...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Anesthesiology - General / Other in Everett, WA

    Locum Physician (MD / DO) - Anesthesiology - General / Other in Everett, WA

    LocumJobsOnline • Everett, WA, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with CompHealth to find a qualified Anesthesiology MD in Everett, Washington, 98201!.CompHealth exists to make the locums process easier. Not only will we search for jobs ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Cardiology - General / Other - $340 to $350 per hour in Everett, WA

    Locum Physician (MD / DO) - Cardiology - General / Other - $340 to $350 per hour in Everett, WA

    LocumJobsOnline • Everett, WA, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with Aya Locums to find a qualified Cardiology MD in Everett, Washington, 98201!.Aya Locums has an immediate opening for a locum Cardiology job in Everett, WA paying $340...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical Technologist - $1,942 to $2,153 per week in Spokane, WA

    Travel Medical Technologist - $1,942 to $2,153 per week in Spokane, WA

    AlliedTravelNetwork • Tacoma, Washington, US
    serp_jobs.job_card.full_time
    AlliedTravelNetwork is working with LRS Healthcare to find a qualified Medical Technologist in Spokane, Washington, 99204!. Ready to start your next travel adventure? LRS Healthcare offers a full be...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Anesthesiology - General / Other in Everett, WA

    Locum Physician (MD / DO) - Anesthesiology - General / Other in Everett, WA

    LocumJobsNetwork • Everett, WA, US
    serp_jobs.job_card.full_time +1
    LocumJobsNetwork is working with CompHealth to find a qualified Anesthesiology MD in Everett, Washington, 98201!.CompHealth exists to make the locums process easier. Not only will we search for jobs...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical Intensive Care Unit - $2,000 to $2,347 per week in Everett, WA

    Travel Nurse RN - Medical Intensive Care Unit - $2,000 to $2,347 per week in Everett, WA

    TravelNurseSource • Everett, WA, US
    serp_jobs.job_card.full_time +1
    TravelNurseSource is working with Lancesoft Inc to find a qualified MICU RN in Everett, Washington, 98201!.Registered Nurse - MICU @ Providence Regional Medical Center Everett Colby Campus.Night 3x...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Regional Medical Director Women's Health - East Pierce

    Regional Medical Director Women's Health - East Pierce

    MultiCare Health System • Puyallup, US
    serp_jobs.job_card.full_time
    FTE Salary min $105,000 - Salary max $150,000.The Regional Medical Director (RMD), Women’s Health has direct responsibility, in conjunction with leadership personnel within MultiCare Medical Partne...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    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 • Seattle, WA, 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