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 • Charleston, SC, 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 • Charleston, SC, United States
10 days ago
Job type
  • Full-time
  • Remote
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.

    Create a job alert for this search

    Principal Medical Writer • Charleston, SC, United States

    Related jobs
    Travel Medical-Surgical RN (Family Medicine)

    Travel Medical-Surgical RN (Family Medicine)

    The Good Life MedStaff • Charleston, SC, US
    Full-time
    The Good Life MedStaff is seeking a travel nurse RN Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. The Good Life MedStaff Job ID #34914492.Pay pa...Show more
    Last updated: 1 day ago • Promoted
    Locum Physician (MD / DO) - Emergency Medicine in Sumter, SC

    Locum Physician (MD / DO) - Emergency Medicine in Sumter, SC

    LocumJobsOnline • North Charleston, US
    Full-time
    LocumJobsOnline is working with Weatherby Healthcare to find a qualified Emergency Medicine MD in Sumter, South Carolina, 29150!. If this opportunity sounds right for you, give us a call today to sp...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Nurse Coordinator - Preop PACU

    Clinical Nurse Coordinator - Preop PACU

    Trident Ambulatory Surgery Center • North Charleston, SC, US
    Full-time +1
    Do you currently have an opportunity to make a real impact with your work? With over 2,000 sites of care and serving over 31. Trident Ambulatory Surgery Center have the opportunity to make a real im...Show more
    Last updated: 6 hours ago • Promoted • New!
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • Charleston, SC, United States
    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...Show more
    Last updated: 30+ days ago • Promoted
    Travel Medical-Surgical RN (Family Medicine)

    Travel Medical-Surgical RN (Family Medicine)

    PRIDE Health • Charleston, SC, US
    Full-time
    PRIDE Health is seeking a travel nurse RN Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. Pay package is based on 12 hour shifts and 36.Posted job...Show more
    Last updated: 13 days ago • Promoted
    Remote M&A Associate - AI Trainer ($50-$60 / hour)

    Remote M&A Associate - AI Trainer ($50-$60 / hour)

    Data Annotation • North Charleston, South Carolina
    Remote
    Full-time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...Show more
    Last updated: 22 days ago • Promoted
    Locum Nurse Practitioner (NP) - Oncology - General / Other in South Carolina

    Locum Nurse Practitioner (NP) - Oncology - General / Other in South Carolina

    LocumJobsOnline • North Charleston, US
    Full-time
    LocumJobsOnline is working with LocumTenens.Oncology NP in South Carolina!.Job Reference Id : ORD-205507-NP-SC.Dates Needed : February 1, 2026 - September 30, 2026. Board Certification Required : Ye...Show more
    Last updated: 1 day ago • Promoted
    Locum Physician Assistant (PA) - Oncology - General / Other in South Carolina

    Locum Physician Assistant (PA) - Oncology - General / Other in South Carolina

    LocumJobsOnline • North Charleston, US
    Full-time
    LocumJobsOnline is working with LocumTenens.Oncology PA in South Carolina!.Job Reference Id : ORD-205507-PA-SC.Dates Needed : February 1, 2026 – September 30, 2026. Board Certification Required : Ye...Show more
    Last updated: 1 day ago • Promoted
    Travel Medical-Surgical RN (Family Medicine)

    Travel Medical-Surgical RN (Family Medicine)

    Planet Healthcare • Charleston, SC, US
    Full-time
    Planet Healthcare is seeking a travel nurse RN Med Surg for a travel nursing job in Charleston, South Carolina.Job Description & Requirements. Planet Healthcare Job ID #74178281.Pay package is b...Show more
    Last updated: 13 days ago • Promoted
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • Charleston, SC, United States
    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: 9 days ago • Promoted
    Travel Medical-Surgical RN (Family Medicine)

    Travel Medical-Surgical RN (Family Medicine)

    GHR Healthcare - Travel Division • Charleston, SC, US
    Full-time
    GHR Healthcare - Travel Division is seeking a travel nurse RN Med Surg for a travel nursing job in Charleston, South Carolina. Job Description & Requirements.GHR Healthcare - Travel Division Job...Show more
    Last updated: 13 days ago • Promoted
    Locum Nurse Practitioner (NP) - Hematology and Oncology in Greenville, SC

    Locum Nurse Practitioner (NP) - Hematology and Oncology in Greenville, SC

    LocumJobsNetwork • North Charleston, US
    Full-time
    LocumJobsNetwork is working with Adelphi Locums to find a qualified Hematology and Oncology NP in Greenville, South Carolina, 29601!. Specialty : Hematology & Oncology-NP / PA.Facility Location : Gr...Show more
    Last updated: 12 hours ago • Promoted • New!
    Locum Physician (MD / DO) - Emergency Medicine in Sumter, SC

    Locum Physician (MD / DO) - Emergency Medicine in Sumter, SC

    LocumJobsNetwork • North Charleston, US
    Full-time
    LocumJobsNetwork is working with Weatherby Healthcare to find a qualified Emergency Medicine MD in Sumter, South Carolina, 29150!. If this opportunity sounds right for you, give us a call today to s...Show more
    Last updated: 30+ days ago • Promoted
    Locum Nurse Practitioner (NP) - Oncology - General / Other in South Carolina

    Locum Nurse Practitioner (NP) - Oncology - General / Other in South Carolina

    LocumJobsNetwork • North Charleston, US
    Full-time
    LocumJobsNetwork is working with LocumTenens.Oncology NP in South Carolina!.Job Reference Id : ORD-205507-NP-SC.Dates Needed : February 1, 2026 - September 30, 2026. Board Certification Required : Y...Show more
    Last updated: 1 day ago • Promoted
    Travel MRI Technologist

    Travel MRI Technologist

    TRS Healthcare • North Charleston, SC, US
    Full-time
    TRS Healthcare is seeking a travel MRI Technologist for a travel job in North Charleston, South Carolina.Job Description & Requirements. TRS Healthcare Job ID #1412283.Pay package is based on 12...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Medical-Surgical - $1,584 to $1,829 per week in Sumter, SC

    Travel Nurse RN - Medical-Surgical - $1,584 to $1,829 per week in Sumter, SC

    TravelNurseSource • North Charleston, South Carolina, US
    Full-time
    TravelNurseSource is working with National Staffing Solutions to find a qualified Med / Surg RN in Sumter, South Carolina, 29150!. Details of the RN - Medical Surgical / Telemetry (MS / TELE) opening in S...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Clinic

    Travel Nurse RN - Clinic

    Premier Medical Staffing Services • Charleston, SC, US
    Permanent
    Premier Medical Staffing Services is seeking a travel nurse RN Clinic for a travel nursing job in Charleston, South Carolina. Job Description & Requirements.Premier Medical Staffing Job ID #6079...Show more
    Last updated: 6 hours ago • Promoted • New!
    Travel MRI Technologist

    Travel MRI Technologist

    Lifeline Medical Staffing • Charleston, SC, US
    Full-time
    Lifeline Medical Staffing is seeking a travel MRI Technologist for a travel job in Charleston, South Carolina.Job Description & Requirements. Lifeline Medical Staffing Job ID #71411996.Pay packa...Show more
    Last updated: 22 hours ago • Promoted • New!