Talent.com
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 BasedSyneos Health/ inVentiv Health Commercial LLC • Sioux Falls, SD, United States
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 • Sioux Falls, SD, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
  • [filters.remote]
[job_card.job_description]

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

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

  • Develop regulatory documents for submission to regulatory agencies globally including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study / project timelines and corporate objectives.
  • Manage medical writing projects, including developing timelines (working with the study / project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
  • Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
  • Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
  • eCTD submission experience preferred.
  • We don't need for this person to mentor junior writers, manage external vendors, or participate in the standard operational procedures or other department initiatives. And I don't have a preference for the EU versus US. We have writers located on both sides and work globally as a team.
  • 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.

    [job_alerts.create_a_job]

    Principal Medical Writer • Sioux Falls, SD, United States

    [internal_linking.similar_jobs]
    Remote Medical Fellows (Must be in Fellowship) - AI Trainer ($130-$130 per hour)

    Remote Medical Fellows (Must be in Fellowship) - AI Trainer ($130-$130 per hour)

    Mercor • Sioux Falls, South Dakota, US
    [filters.remote]
    [job_card.full_time]
    Mercor is seeking • •clinical fellows • • across any specialty (except radiology) for a project with one of the world’s top AI labs. This project is specifically focused on medical reasoning related ca...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse RN - Med Surg

    Travel Nurse RN - Med Surg

    Fusion Medical Staffing-Nursing • Sioux Falls, SD, US
    [job_card.full_time]
    Fusion Medical Staffing-Nursing is seeking a travel nurse RN Med Surg for a travel nursing job in Sioux Falls, South Dakota. Job Description & Requirements.Facility in Sioux Falls, South Dakota....[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse RN - Long Term Care (LTC) Long Term Care

    Travel Nurse RN - Long Term Care (LTC) Long Term Care

    GetMed Staffing, Inc. • Flandreau, SD, US
    [job_card.full_time]
    RN Long Term Care (LTC) Long Term Care for a travel nursing job in Flandreau, South Dakota.Job Description & Requirements. GetMed Staffing is searching for a strong Long Term Care RN to assist o...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Travel Nurse RN - Long-Term Care - $1,478 to $1,699 per week in Flandreau, SD

    Travel Nurse RN - Long-Term Care - $1,478 to $1,699 per week in Flandreau, SD

    TravelNurseSource • Flandreau, SD, US
    [job_card.full_time]
    TravelNurseSource is working with Fusion Medical Staffing to find a qualified Long-Term Care RN in Flandreau, South Dakota, 57028!. Facility in Flandreau, South Dakota.Fusion Medical Staffing is see...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote Bilingual Simplified Chinese Medical Expert - AI Trainer ($100-$160 per hour)

    Remote Bilingual Simplified Chinese Medical Expert - AI Trainer ($100-$160 per hour)

    Mercor • Sioux Falls, South Dakota, US
    [filters.remote]
    [job_card.full_time]
    Mercor is seeking • •native Mandarin speakers • • who can read / write in • •Simplified Chinese • • and are also • •medical professionals • • who have worked in China. This role combines your • •clinical expert...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Remote Medical and Health Services Managers - AI Trainer ($80-$110 per hour)

    Remote Medical and Health Services Managers - AI Trainer ($80-$110 per hour)

    Mercor • Sioux Falls, South Dakota, US
    [filters.remote]
    [job_card.full_time]
    About the Role • • Mercor is seeking experienced • •medical and health services managers • • to support a leading AI lab in advancing research and infrastructure for next-generation machine learning sys...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse - RN - MS - Medical Surgical - $1694.93 / Week

    Travel Nurse - RN - MS - Medical Surgical - $1694.93 / Week

    FlexCare • Sioux Falls, SD, US
    [job_card.full_time]
    FlexCare is seeking an experienced Medical Surgical Registered Nurse for an exciting Travel Nursing job in Sioux Falls, SD. Shift : 3x12 hr days Start Date : 01 / 05 / 2026 Duration : 13 weeks Pay : $1694.W...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse RN - Long Term Care (LTC) Long Term Care

    Travel Nurse RN - Long Term Care (LTC) Long Term Care

    Care Career • Flandreau, SD, US
    [job_card.full_time]
    Care Career is seeking a travel nurse RN Long Term Care (LTC) Long Term Care for a travel nursing job in Flandreau, South Dakota. Job Description & Requirements.Long term care nurses specialize ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse RN - Med Surg

    Travel Nurse RN - Med Surg

    CrossMed • Sioux Falls, SD, US
    [job_card.full_time]
    CrossMed is seeking a travel nurse RN Med Surg for a travel nursing job in Sioux Falls, South Dakota.Job Description & Requirements. At CrossMed Healthcare Staffing, we aim to create lasting imp...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse RN - Long Term Care

    Travel Nurse RN - Long Term Care

    Genie Healthcare • Flandreau, SD, US
    [job_card.full_time]
    Genie Healthcare is seeking a travel nurse RN Long Term Care for a travel nursing job in Flandreau, South Dakota.Job Description & Requirements. Genie Healthcare is one of the fastest growing Nu...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • Sioux Falls, SD, United States
    [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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse - RN - LTC - Long Term Care - $1699 / Week - Hiring Now

    Travel Nurse - RN - LTC - Long Term Care - $1699 / Week - Hiring Now

    Fusion Medical Staffing • Flandreau, SD, US
    [job_card.full_time]
    Fusion Medical Staffing is seeking an experienced Long Term Care Registered Nurse for an exciting Travel Nursing job in Flandreau, SD. Shift : Inquire Start Date : 12 / 15 / 2025 Duration : 8 weeks Pay : $1...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse RN - Long Term Care (LTC) Long Term Care

    Travel Nurse RN - Long Term Care (LTC) Long Term Care

    Genie Healthcare • Flandreau, SD, US
    [job_card.full_time]
    Genie Healthcare is seeking a travel nurse RN Long Term Care (LTC) Long Term Care for a travel nursing job in Flandreau, South Dakota. Job Description & Requirements.Genie Healthcare is looking ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse - RN - SNF - Skilled Nursing Facility - $1896.05 / Week

    Travel Nurse - RN - SNF - Skilled Nursing Facility - $1896.05 / Week

    Host Healthcare • Canton, SD, US
    [job_card.full_time]
    Host Healthcare is seeking an experienced Skilled Nursing Facility Registered Nurse for an exciting Travel Nursing job in Canton, SD. Shift : Inquire Start Date : 01 / 05 / 2026 Duration : 13 weeks Pay : $1...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Telemedicine Physician

    Telemedicine Physician

    QuickMD • Canton, SD, US
    [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...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse - RN - LTC - Long Term Care - $1699 / Week

    Travel Nurse - RN - LTC - Long Term Care - $1699 / Week

    Fusion Medical Staffing • Flandreau, SD, US
    [job_card.full_time]
    Fusion Medical Staffing is seeking an experienced Long Term Care Registered Nurse for an exciting Travel Nursing job in Flandreau, SD. Shift : Inquire Start Date : 12 / 15 / 2025 Duration : 8 weeks Pay : $1...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse - RN - MS - Medical Surgical - $1694.93 / Week - Hiring Now

    Travel Nurse - RN - MS - Medical Surgical - $1694.93 / Week - Hiring Now

    FlexCare • Sioux Falls, SD, US
    [job_card.full_time]
    FlexCare is seeking an experienced Medical Surgical Registered Nurse for an exciting Travel Nursing job in Sioux Falls, SD. Shift : 3x12 hr days Start Date : 01 / 05 / 2026 Duration : 13 weeks Pay : $1694.W...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse RN - Long Term Care (LTC) Long Term Care

    Travel Nurse RN - Long Term Care (LTC) Long Term Care

    Skyline Med Staff Home Health • Flandreau, SD, US
    [job_card.full_time]
    Skyline Med Staff Home Health is seeking a travel nurse RN Long Term Care (LTC) Long Term Care for a travel nursing job in Flandreau, South Dakota. Job Description & Requirements.Weekly amount s...[show_more]
    [last_updated.last_updated_30] • [promoted]