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 • Bridgeport, CT, 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 • Bridgeport, CT, United States
1 day 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 • Bridgeport, CT, United States

    Related jobs
    Sr Medical Writer (Publications)

    Sr Medical Writer (Publications)

    Syneos Health / inVentiv Health Commercial LLC • Bridgeport, CT, 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: 1 day ago • Promoted
    Remote AI Writing Evaluator

    Remote AI Writing Evaluator

    Outlier • Bridgeport, CT, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 11 days ago • Promoted
    Remote AI Writing Specialist

    Remote AI Writing Specialist

    Outlier • Bridgeport, CT, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 8 days ago • Promoted
    Flexible Content Writer

    Flexible Content Writer

    Outlier • Bridgeport, CT, United States
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 8 days ago • Promoted
    Freelance Writer

    Freelance Writer

    Outlier • Bridgeport, CT, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 11 days ago • Promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLC • Bridgeport, CT, United States
    Full-time
    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 ...Show more
    Last updated: 22 days ago • Promoted
    Home-Based Freelance Writer

    Home-Based Freelance Writer

    Outlier • Bridgeport, CT, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 8 days ago • Promoted
    Primary Care Physicians (FM or IM) | Beautiful Hudson Valley | Optum NY

    Primary Care Physicians (FM or IM) | Beautiful Hudson Valley | Optum NY

    Optum • Hopewell Junction, NY, US
    Full-time
    K Sign-On Bonus and $50K in Retention Bonuses • •.Optum NY, (formerly Optum Tri-State NY) is seeking exceptional Primary Care Physicians (FM or IM) to join our. Hudson Valley clinics in Poughkeepsie, ...Show more
    Last updated: 1 day ago • Promoted
    Cytotechnologist

    Cytotechnologist

    Medical Solutions Direct Hire • White Plains, NY, US
    Permanent
    Medical Solutions Direct Hire is seeking a Cytotechnologist for a job in White Plains, New York.Job Description & Requirements. Medical Solutions Direct Hire Job ID #960467.About Medical Solutio...Show more
    Last updated: 30+ days ago • Promoted
    Yale Medicine : Clinical Urologist - Assistant / Associate Professor

    Yale Medicine : Clinical Urologist - Assistant / Associate Professor

    Yale Medicine • Greenwich, US
    Full-time
    Due to growth and expansion of services, Yale Medicine is seeking full-time W2 Urologists to join our General & Pediatric faculty staff to provide high-quality multidisciplinary care at our hospita...Show more
    Last updated: 30+ days ago • Promoted
    Travel Hematology / Transplant Oncology RN

    Travel Hematology / Transplant Oncology RN

    PRN Healthcare • New Haven, CT, US
    Full-time
    PRN Healthcare is seeking a travel nurse RN Hematology / Oncology for a travel nursing job in New Haven, Connecticut.Job Description & Requirements. PRN Healthcare Job ID #1469930.Pay package is...Show more
    Last updated: 7 days ago • Promoted
    AI Content Writer - Work From Home

    AI Content Writer - Work From Home

    Outlier • Bridgeport, CT, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 8 days ago • Promoted
    MEDICAL SPECIALIST

    MEDICAL SPECIALIST

    US Army • New Haven, Connecticut, United States
    Full-time +1
    ELIGIBLE FOR UP TO A $10K SIGNING BONUS.TALK TO YOUR RECRUITER FOR DETAILS.THIS POSITION REQUIRES AN ENLISTMENT IN THE U. As a Combat Medic Specialist, you'll administer emergency medical care in th...Show more
    Last updated: 5 days ago • Promoted
    Director of Biostatistics for Cancer Center Shared

    Director of Biostatistics for Cancer Center Shared

    InsideHigherEd • Stony Brook, New York, United States
    Full-time
    Director of Biostatistics for Cancer Center Shared Resource, Associate / Full Professor, Cancer Center & Family Population & Preventive Medicine, Biostatistics. Oct 30, 2025 at 11 : 59 PM Eastern Time ....Show more
    Last updated: 30+ days ago • Promoted
    AI Writing Reviewer - Remote

    AI Writing Reviewer - Remote

    Outlier • Bridgeport, CT, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 8 days ago • Promoted
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • Bridgeport, CT, 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 hour ago • Promoted • New!
    Remote Work From Home Writer

    Remote Work From Home Writer

    Outlier • Bridgeport, CT, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 8 days ago • Promoted
    Remote Flexible Writer

    Remote Flexible Writer

    Outlier • Bridgeport, CT, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 8 days ago • Promoted