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 • Salt Lake City, UT, 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 • Salt Lake City, UT, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
  • [filters.remote]
[job_card.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.

    [job_alerts.create_a_job]

    Principal Medical Writer • Salt Lake City, UT, United States

    [internal_linking.related_jobs]
    Freelance Research Contributor (Hiring Immediately)

    Freelance Research Contributor (Hiring Immediately)

    Maxion Research • Saratoga Springs, Utah, US
    [job_card.part_time]
    Join Our Part-Time Research Studies Today!.Are you eager to earn extra income from the comfort of your home? We are looking for motivated individuals to participate in paid research studies includi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote Freelance Content Writer

    Remote Freelance Content Writer

    Outlier • West Jordan, UT, United States
    [filters.remote]
    [job_card.full_time]
    Earn up to $16 USD / hourly and work remotely and flexibly.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 ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Physician - Family Medicine

    Physician - Family Medicine

    Trinity Health • Saratoga Springs, US
    [job_card.full_time]
    Peters Health Partners Medical Associates is thrilled to offer a full-time Family Medicine physician position at our brand-new primary care practice located at 631 Maple Ave in Wilton, NY.This is a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Donor Center Phlebotomist

    Donor Center Phlebotomist

    American Red Cross • Lehi, UT, United States
    [job_card.full_time]
    Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Medical Affairs Field Director

    Medical Affairs Field Director

    Scientific Search • Salt Lake City, UT, US
    [job_card.full_time]
    A commercial-stage biotechnology company developing cell and immunotherapy products to eliminate cancerous or infected cells. Engage in the exchange of scientific data and education of health care p...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote Financial Expert - AI Trainer ($150 per hour)

    Remote Financial Expert - AI Trainer ($150 per hour)

    Mercor • Lehi, Utah, US
    [filters.remote]
    [job_card.full_time]
    UK / Canada / Europe / Singapore / Dubai / Australia-based • •Investment Banking or Private Equity Experts • • for a research project with a leading foundational model AI lab. You are a good fit if you : - Have •...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Remote Freelance Research Contributor (Hiring Immediately)

    Remote Freelance Research Contributor (Hiring Immediately)

    Maxion Research • Clearfield, Utah, US
    [filters.remote]
    [job_card.part_time]
    Join Our Part-Time Research Studies Today!.Are you eager to earn extra income from the comfort of your home? We are looking for motivated individuals to participate in paid research studies includi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Clinical Research Associate, Oncology

    Clinical Research Associate, Oncology

    ICON Strategic Solutions • Salt Lake City, UT, US
    [job_card.full_time]
    Clinical Research Associate - Oncology - Colorado.ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innov...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Oral Surgery Partnership

    Oral Surgery Partnership

    HealthEcareers - Client • Farmington, UT, USA
    [job_card.full_time]
    We’re excited to offer an immediate opportunity for an oral surgeon to join our established practice in the northern Utah valley. This is an incredible opportunity to join a group of thriving OMS pr...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    DVM Medical Director - Co-Owner

    DVM Medical Director - Co-Owner

    Peoplepack LLC - Recruiting Solutions • Lehi, UT, US
    [job_card.full_time]
    We are recruiting for an entrepreneurial Veterinarian leader who is interested in managing a NEW stand-alone GP hospital, as a co-owner, building and leading a veterinary team, while reaping the fi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • Salt Lake City, UT, United States
    [job_card.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.last_updated_variable_days] • [promoted]
    Locum Physician (MD / DO) - Cardiology - General / Other in Lehi, UT

    Locum Physician (MD / DO) - Cardiology - General / Other in Lehi, UT

    LocumJobsNetwork • Lehi, UT, US
    [job_card.full_time]
    LocumJobsNetwork is working with Weatherby Healthcare to find a qualified Cardiology MD in Lehi, Utah, 84043!.Weatherby can help you build a custom career plan, with multiple positions available fo...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote Financial Planner - AI Trainer ($150 per hour)

    Remote Financial Planner - AI Trainer ($150 per hour)

    Mercor • Lehi, Utah, US
    [filters.remote]
    [job_card.full_time]
    UK / Canada / Europe / Singapore / Dubai / Australia-based • •Investment Banking or Private Equity Experts • • for a research project with a leading foundational model AI lab. You are a good fit if you : - Have •...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Locum Physician (MD / DO) - Cardiology - General / Other in Lehi, UT

    Locum Physician (MD / DO) - Cardiology - General / Other in Lehi, UT

    LocumJobsOnline • Lehi, UT, US
    [job_card.full_time] +1
    LocumJobsOnline is working with Weatherby Healthcare to find a qualified Cardiology MD in Lehi, Utah, 84043!.Weatherby can help you build a custom career plan, with multiple positions available for...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Telemedicine Physician

    Telemedicine Physician

    QuickMD • Lehi, UT, US
    [job_card.full_time]
    QuickMD is a leading telemedicine provider, delivering high-quality virtual care across 44 states.Since our founding in 2019, we have helped more than 100,000 patients access essential medical trea...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Medical Science Liaison - Nephrology

    Senior Medical Science Liaison - Nephrology

    Ardelyx • Salt Lake City, UT, United States
    [job_card.full_time]
    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medic...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Family Medicine Physician - St. Peter's Primary Care

    Family Medicine Physician - St. Peter's Primary Care

    Trinity Health • Saratoga Springs, US
    [job_card.full_time]
    Peters Health Partners Medical Associates.This is an exciting opportunity to join an existing outpatient practice with strong patient demand and hospital affiliated practice support!.Congress Place...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Field Medical Director- (MD / DO)

    Field Medical Director- (MD / DO)

    Evolent • Salt Lake City, UT, United States
    [job_card.full_time]
    Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and primary care, we seek to connect...[show_more]
    [last_updated.last_updated_30] • [promoted]