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 • Philadelphia, PA, 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 • Philadelphia, PA, United States
2 days ago
Job type
  • Full-time
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 • Philadelphia, PA, United States

    Related jobs
    Travel MRI Technologist

    Travel MRI Technologist

    Host Healthcare • Washington Township, NJ, US
    Full-time
    Host Healthcare is seeking a travel MRI Technologist for a travel job in Washington Township, New Jersey.Job Description & Requirements. Pay package is based on 12 hour shifts and 36 hours per w...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - ED - Emergency Department

    Travel Nurse RN - ED - Emergency Department

    Talent4Health • Mullica Hill, NJ, US
    Full-time
    Talent4Health is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Mullica Hill, New Jersey. Job Description & Requirements.Three (3) years of recent ED experience ...Show more
    Last updated: 30+ days ago • 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 • Philadelphia, PA, United States
    Remote
    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,...Show more
    Last updated: 2 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 • Philadelphia, PA, 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: 14 days ago • Promoted
    Travel MRI Tech - $2,092 to $2,404 per week in Washington Township, NJ

    Travel MRI Tech - $2,092 to $2,404 per week in Washington Township, NJ

    AlliedTravelCareers • Washington Township, NJ, US
    Full-time
    AlliedTravelCareers is working with Fusion Medical Staffing to find a qualified MRI Tech in Washington Township, New Jersey, 08012!. Facility in Turnersville, New Jersey.Fusion Medical Staffing is s...Show more
    Last updated: 6 days ago • Promoted
    Local Contract MRI Technologist

    Local Contract MRI Technologist

    ARMStaffing • Blackwood, NJ, US
    Full-time
    ARMStaffing is seeking a local contract MRI Technologist for a local contract job in Blackwood, New Jersey.Job Description & Requirements. MRI Tech - Radiology / Cardiology\n\n.This is a 13-week...Show more
    Last updated: 2 days ago • Promoted
    Travel MRI Technologist

    Travel MRI Technologist

    CrossMed • Washington Township, NJ, US
    Full-time
    CrossMed is seeking a travel MRI Technologist for a travel job in Washington Township, New Jersey.Job Description & Requirements. At CrossMed Healthcare Staffing, we aim to create lasting impres...Show more
    Last updated: 5 days ago • Promoted
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • Philadelphia, PA, 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: 1 day ago • Promoted
    Medical Writer / Content Specialist

    Medical Writer / Content Specialist

    Octane Learning • Princeton, NJ, US
    Full-time
    Quick Apply
    THE COMPANY Octane Learning is a professional learning and medical communications agency, working exclusively for pharmaceutical, biotech, medical device, and healthcare companies.We advise o...Show more
    Last updated: 30+ days ago
    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 • Philadelphia, PA, United States
    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: 8 days ago • Promoted
    Travel MRI Technologist

    Travel MRI Technologist

    MedPro Healthcare Allied Staffing • Turnersville, NJ, US
    Full-time
    MedPro Healthcare Allied Staffing is seeking a travel MRI Technologist for a travel job in Turnersville, New Jersey.Job Description & Requirements. Joint Commission-certified staffing agency, is...Show more
    Last updated: 30+ days ago • Promoted
    Sr Medical Writer (Publications)

    Sr Medical Writer (Publications)

    Syneos Health / inVentiv Health Commercial LLC • Philadelphia, PA, 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: 2 days ago • Promoted
    Specialist 4 - Medical Writing

    Specialist 4 - Medical Writing

    eTeam Inc • Titusville, New Jersey, United States
    Full-time
    Quick Apply
    Company is recruiting for a Manager, Medical Information, Payer and Health Systems.We believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex d...Show more
    Last updated: 30+ days ago
    Local Contract MRI Technologist

    Local Contract MRI Technologist

    Host Healthcare • Washington Township, NJ, US
    Full-time
    Host Healthcare is seeking a local contract MRI Technologist for a local contract job in Washington Township, New Jersey. Job Description & Requirements.Pay package is based on 12 hour shifts an...Show more
    Last updated: 30+ days ago • Promoted
    Travel MRI Technologist

    Travel MRI Technologist

    Uniti Med • Washington Township, NJ, US
    Full-time
    Uniti Med is seeking a travel MRI Technologist for a travel job in Washington Township, New Jersey.Job Description & Requirements. Cigna medical, MetLife dental and vision insurance .Licens...Show more
    Last updated: 30+ days ago • Promoted
    Travel MRI Technologist

    Travel MRI Technologist

    PRN Healthcare • Turnersville, NJ, US
    Full-time
    PRN Healthcare is seeking a travel MRI Technologist for a travel job in Turnersville, New Jersey.Job Description & Requirements. PRN Healthcare Job ID #1457999.Pay package is based on 12 hour sh...Show more
    Last updated: 30+ days ago • Promoted
    Medical Editor

    Medical Editor

    Breaking Data • Cherry Hill, NJ, United States
    Full-time
    Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-i...Show more
    Last updated: 12 hours ago • Promoted • New!
    Medical Writer (Advanced Degree)

    Medical Writer (Advanced Degree)

    Octane Learning • Princeton, NJ, US
    Full-time
    Quick Apply
    THE COMPANY Octane Learning is a professional learning and medical communications agency, working exclusively for pharmaceutical, biotech, medical device, and healthcare companies.We advise o...Show more
    Last updated: 30+ days ago