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 • New Orleans, LA, 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 • New Orleans, LA, United States
5 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 • New Orleans, LA, United States

    Related jobs
    Medical Director

    Medical Director

    National Staffing Solutions • New Orleans, LA, United States
    Full-time
    Primary Care Physician / Medical Director.We are seeking a dynamic physician leader to provide and oversee patient care for the medically complex & socially vulnerable members of the New Orleans Co...Show more
    Last updated: 30+ days ago • Promoted
    Chief Medical Executive

    Chief Medical Executive

    ChenMed • New Orleans, LA, United States
    Full-time
    Join Our Transformative Healthcare Team!.At ChenMed, we are dedicated to making a difference in the lives of our patients and team members every day. If you are innovative, have an entrepreneurial s...Show more
    Last updated: 15 days ago • Promoted
    Senior Medical Assistant - PRN

    Senior Medical Assistant - PRN

    LCMC Health • New Orleans, LA, US
    Full-time
    Crescent City Physicians Incorporated.Work Shift : Days (United States of America).While our NOLA roots run deep, our branches are the vessels that carry our mission of bringing the best possible ca...Show more
    Last updated: 30+ days ago • Promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • New Orleans, LA, 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
    Associate Chief Medical Officer

    Associate Chief Medical Officer

    ChenMed • Gretna, LA, United States
    Full-time
    We're changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with ...Show more
    Last updated: 15 days ago • Promoted
    Medical Manager

    Medical Manager

    ChenMed • New Orleans, LA, United States
    Full-time
    We’re changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with ...Show more
    Last updated: 30+ days ago • Promoted
    Associate Medical Manager

    Associate Medical Manager

    ChenMed • New Orleans, LA, US
    Full-time
    We’re changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire o...Show more
    Last updated: 30+ days ago • Promoted
    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based

    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based

    Syneos Health / inVentiv Health Commercial LLC • New Orleans, LA, United States
    Remote
    Full-time
    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to acceler...Show more
    Last updated: 11 days ago • Promoted
    Medical Assistant - Endocrinology Clinic

    Medical Assistant - Endocrinology Clinic

    Ochsner Health • New Orleans, LA, US
    Full-time
    We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned, every ...Show more
    Last updated: 30+ days ago • Promoted
    Medical Assistant Specialist - Podiatry

    Medical Assistant Specialist - Podiatry

    Louisiana Staffing • New Orleans, LA, US
    Full-time
    We're changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with y...Show more
    Last updated: 21 days ago • Promoted
    Senior Medical Director - Psychiatrist - Remote Based

    Senior Medical Director - Psychiatrist - Remote Based

    Syneos Health / inVentiv Health Commercial LLC • New Orleans, LA, United States
    Remote
    Full-time
    Senior Medical Director - Psychiatrist - Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique c...Show more
    Last updated: 30+ days ago • Promoted
    Medical Assistant - Endocrinology Clinic

    Medical Assistant - Endocrinology Clinic

    Louisiana Staffing • New Orleans, LA, US
    Full-time
    We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned, every ...Show more
    Last updated: 30+ days ago • Promoted
    Associate Chief Medical Officer of Clinical Operations

    Associate Chief Medical Officer of Clinical Operations

    ChenMed • Gretna, LA, United States
    Full-time
    Join Our Transformative Healthcare Team!.At ChenMed, we are making a difference in the lives of our patients and team members. If you are innovative, entrepreneurial-minded, and have a strong work e...Show more
    Last updated: 15 days ago • Promoted
    Senior Medical Editor - Regulatory - Home Based

    Senior Medical Editor - Regulatory - Home Based

    Syneos Health / inVentiv Health Commercial LLC • New Orleans, LA, United States
    Full-time
    Senior Medical Editor - Regulatory - Home Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinica...Show more
    Last updated: 1 day ago • Promoted
    Medical Assistant

    Medical Assistant

    Louisiana Staffing • New Orleans, LA, US
    Full-time
    We're changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with y...Show more
    Last updated: 30+ days ago • Promoted
    Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

    Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

    Syneos Health / inVentiv Health Commercial LLC • New Orleans, LA, United States
    Remote
    Full-time
    Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...Show more
    Last updated: 11 days ago • Promoted
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • New Orleans, LA, 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: 4 days ago • Promoted
    Sr Medical Writer (Publications)

    Sr Medical Writer (Publications)

    Syneos Health / inVentiv Health Commercial LLC • New Orleans, LA, United States
    Full-time
    Sr Medical Writer (Publications).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affa...Show more
    Last updated: 5 days ago • Promoted