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 York, NY, 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 York, NY, 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 York, NY, United States

    Related jobs
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • New York, NY, 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: 3 days ago • Promoted
    Senior Medical Writer

    Senior Medical Writer

    Flywheel Partners • New York, NY, US
    Full-time
    Quick Apply
    DESCRIPTION Flywheel (flywheelpartners.Learning modules, slide presentations, product brochures, backgrounders, videos, podcasts, learning games and skills development workshops.We partner with pha...Show more
    Last updated: 30+ days ago
    Senior Manager, Medical Information, Oncology

    Senior Manager, Medical Information, Oncology

    Eisai • Nutley, NJ, United States
    Full-time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...Show more
    Last updated: 8 days ago • Promoted
    Certified Medical Assistant- Endocrinology - Physician Practice

    Certified Medical Assistant- Endocrinology - Physician Practice

    HMH PHYSICIAN SERVICES, INC. • Neptune City, NJ, United States
    Full-time
    Our team members are the heart of what makes us better.With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning.It’s a...Show more
    Last updated: 26 days ago • Promoted
    Certified Medical Assistant - Surgical Group - Physician Pratice

    Certified Medical Assistant - Surgical Group - Physician Pratice

    Hackensack Meridian Health • Oakhurst, NJ, United States
    Full-time +1
    Our team members are the heart of what makes us better.With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning.It's a...Show more
    Last updated: 30+ days ago • Promoted
    Senior Manager, Medical Communications and Content Solutions (MCCS)

    Senior Manager, Medical Communications and Content Solutions (MCCS)

    Pfizer • New York, NY, US
    Full-time
    Senior Manager Medical Content.The Senior Manager will develop and review all relevant medical affairs content, including abstracts, manuscripts, congress posters / presentations, graphical abstracts...Show more
    Last updated: 22 days ago • Promoted
    Regional Medical Director NJ

    Regional Medical Director NJ

    BoldAge PACE • Oceanport, NJ, US
    Full-time
    Join BoldAge PACE and Make a Difference! Why work with us? A People First Environment : We make what is important to those we serve important to us. Make an Impact : Enhance the quality of life for se...Show more
    Last updated: 2 days ago • Promoted
    Sr Medical Writer (Publications)

    Sr Medical Writer (Publications)

    Syneos Health / inVentiv Health Commercial LLC • New York, NY, 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
    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 York, NY, 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: 10 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 York, NY, 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: 10 days ago • Promoted
    Senior Medical Writer (Remote)

    Senior Medical Writer (Remote)

    MMS • Jersey City, NJ, US
    Remote
    Full-time
    Quick Apply
    About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory sub...Show more
    Last updated: 30+ days ago
    Medical Writer - Medical Communications - East Coast

    Medical Writer - Medical Communications - East Coast

    Prime • New York, NY, US
    Full-time
    Quick Apply
    Accelerating Life-Changing Solutions to Global Healthcare Challenges .It speaks to the significant challenges that exist within global healthcare, and how we, as one team, can help to deliver ...Show more
    Last updated: 30+ days ago
    Neurology Medical Director | Leadership Role + Competitive Pay

    Neurology Medical Director | Leadership Role + Competitive Pay

    St. Joseph's University Medical Center • Clifton, NJ, US
    Full-time
    Duties and Responsibilities of Medical Director, Epilepsy / EEG.General : Provide the medical leadership required to oversee the adult Epilepsy program. Develop plans which would enable the hospital ce...Show more
    Last updated: 13 days ago • Promoted
    Medical Director, Breast Oncology

    Medical Director, Breast Oncology

    Pfizer • New York, NY, US
    Permanent
    This position is for a Medical Director within the CDK4 program.This individual contributor position will be responsible for supporting clinical trial(s). The successful candidate should ideally hav...Show more
    Last updated: 21 hours ago • Promoted • New!
    Physician Emergency Medicine - Competitive Salary

    Physician Emergency Medicine - Competitive Salary

    Envision Physician Services • Neptune City, NJ, US
    Full-time
    Hovnanian Children’s Hospital at Jersey Shore University Medical Center in Neptune, NJ, is looking for an accomplished.Pediatric Emergency Medicine Medical Director.Join a nationally recogniz...Show more
    Last updated: 30+ days ago • Promoted
    Certified Medical Assistant

    Certified Medical Assistant

    RWJBarnabas Health • Long Branch, NJ, United States
    Full-time
    SECOND AVENUE, LONG BRANCH, NJ 07740.Job Title : Certified Medical Assistant.Location : Monmouth Medical Center.Department Name : Outpatient Infusion. The above reflects the anticipated hourly wage ran...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 York, NY, 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
    Certified Medical Aide (Local)

    Certified Medical Aide (Local)

    Hired by Matrix • Eatontown, NJ, United States
    Full-time
    Certified Medical Aide (Local).Accepting Locals per Radius Rule?.Completion of a state-approved medicine course with a passing grade. Completion of a state approved certified nursing assistant progr...Show more
    Last updated: 9 days ago • Promoted