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 • Providence, RI, 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 • Providence, RI, United States
5 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 • Providence, RI, United States

    Related jobs
    Travel Medical-Surgical Telemetry Nurse - $2,085 per week

    Travel Medical-Surgical Telemetry Nurse - $2,085 per week

    Premier Medical Staffing Services • Attleboro, MA, US
    Permanent
    Premier Medical Staffing Services is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Attleboro, Massachusetts. Job Description & Requirements.Premier Medical Staffing ...Show more
    Last updated: 24 days ago • Promoted
    Travel Nurse RN - Med Surg - $2,200 per week

    Travel Nurse RN - Med Surg - $2,200 per week

    Host Healthcare • Newport, RI, USA
    Full-time
    Travel Nurse RN - Med Surg - $2,200 per week at Host Healthcare summary : .As a Travel Nurse RN specializing in Med Surg, you will provide critical care in various healthcare settings while enjoying ...Show more
    Last updated: 30+ days ago • Promoted
    Registered Nurse (RN) - Med Surg - $35-48 per hour

    Registered Nurse (RN) - Med Surg - $35-48 per hour

    Medical Solutions Direct Hire • Narragansett, RI, US
    Permanent
    Medical Solutions Direct Hire is seeking a Registered Nurse (RN) Med Surg for a nursing job in Narragansett, Rhode Island. Job Description & Requirements.Medical Solutions Direct Hire Job ID #89...Show more
    Last updated: 10 days ago • Promoted
    Travel Nurse RN - Med Surg - $2,138 per week

    Travel Nurse RN - Med Surg - $2,138 per week

    OneStaff Medical • Newport, RI, USA
    Full-time
    Travel Nurse RN - Med Surg - $2,138 per week at OneStaff Medical summary : .OneStaff Medical is seeking a Travel Nurse RN specialized in Med Surg for a 13-week assignment in Newport, Rhode Island, wh...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Med Surg - $1,753 per week

    Travel Nurse RN - Med Surg - $1,753 per week

    TotalMed Staffing • Newport, RI, USA
    Permanent
    Travel Nurse RN - Med Surg - $1,753 per week at TotalMed Staffing summary : .TotalMed Staffing is seeking a Registered Nurse specializing in Medical-Surgical for a travel assignment in Newport, Rhode...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Med Surg - $2,144 per week

    Travel Nurse RN - Med Surg - $2,144 per week

    Triage Staffing • Newport, RI, USA
    Full-time
    Triage Staffing is seeking a travel nurse RN Med Surg for a travel nursing job in Newport, Rhode Island.Job Description & Requirements. Travel Nursing : Med / Surg Newport.Shift Details : 12H Nights (...Show more
    Last updated: 30+ days ago • Promoted
    Family Medicine Opportunity in Vermont

    Family Medicine Opportunity in Vermont

    AMN Healthcare • Newport, US
    Full-time
    Job Description & Requirements.Family Medicine Opportunity in Vermont.StartDate : ASAP Available Shifts : Full time; M-F Pay Rate : $270000. An award-winning community hospital in scenic Vermont is...Show more
    Last updated: 30+ days ago • Promoted
    Physician - Primary Care

    Physician - Primary Care

    UPMC Central PA • Newport, US
    Full-time
    UPMC Central PA Family Care Newport is seeking a full-time family medicine physician to join our growing primary care team and play an integral role in helping to provide high-quality, compassionat...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - ED - Emergency Department - $2,502 per week

    Travel Nurse RN - ED - Emergency Department - $2,502 per week

    LanceSoft • North Providence, RI, USA
    Permanent
    Travel Nurse RN - ED - Emergency Department - $2,502 per week at LanceSoft summary : .As a Travel Nurse RN specializing in the Emergency Department, I provide critical care to patients in acute situa...Show more
    Last updated: 30+ days ago • Promoted
    Travel Registered Nurse RN Medical Surgical

    Travel Registered Nurse RN Medical Surgical

    OneStaffMedical • Newport, RI, USA
    Full-time
    An independently-owned, nationally-recognized and amazingly awesome staffing firm ready to work for you! A work ethic forged in the Midwest, we are here to stand by your side and help you find ...Show more
    Last updated: 30+ days ago • Promoted
    CRNA

    CRNA

    NewYork-Presbyterian • Newport, RI, US
    Full-time
    Amazing Patients, Inspiring Careers : .Certified Registered Nurse Anesthetist – CRNA - NYP / Hudson Valley- 16 / 24 shifts-. At NewYork-Presbyterian Hospital, Certified Registered Nurse Anesthetists...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse - Medical-Surgical RN $2268 / wk

    Travel Nurse - Medical-Surgical RN $2268 / wk

    Nomad Health • Newport, RI, USA
    Full-time
    Nomad Health seeks an experienced Medical-Surgical registered nurse for a travel assignment in RI.Take the next step in your healthcare career and join Nomad Health as a Medical-Surgical travel nur...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Med Surg - $2,047 per week

    Travel Nurse RN - Med Surg - $2,047 per week

    MedPro Healthcare Staffing • Newport, RI, USA
    Full-time
    Travel Nurse RN - Med Surg - $2,047 per week at MedPro Healthcare Staffing summary : .A Travel Nurse RN specializing in Med-Surg will provide care to adult patients before and after surgical procedur...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Med Surg - $2,305 per week

    Travel Nurse RN - Med Surg - $2,305 per week

    Solomon Page • Newport, RI, USA
    Full-time
    Travel Nurse RN - Med Surg - $2,305 per week at Solomon Page summary : .A Travel Nurse RN specializing in Med Surg is needed for a 13-week assignment in Newport, Rhode Island, starting February 18, 2...Show more
    Last updated: 30+ days ago • Promoted
    Addiction Medicine Physician – OhioHealth Mansfield Hospital – Fellowship Stipend

    Addiction Medicine Physician – OhioHealth Mansfield Hospital – Fellowship Stipend

    OhioHealth • Mansfield, US
    Full-time
    Join an award winning, physician-led health system that prides itself on an inclusive, collegial, and innovative culture. As an Addiction Medicine Physician at OhioHealth.Join a thriving Addiction M...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 • Providence, RI, 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: 5 days ago • Promoted
    Medical Assistant

    Medical Assistant

    APDerm • North Attleboro, MA, US
    Full-time
    APDerm is a physician-led, patient-centered dermatology network.Founded in 1992, we have 38 practices across Massachusetts, New Hampshire and Rhode Island and pride ourselves on being the "partner ...Show more
    Last updated: 30+ days ago • Promoted
    Flexible Content Writer

    Flexible Content Writer

    Outlier • Pawtucket, RI, 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: 1 day ago • Promoted