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 • Oklahoma City, OK, 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 • Oklahoma City, OK, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
  • serp_jobs.filters.remote
job_description.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.

    serp_jobs.job_alerts.create_a_job

    Principal Medical Writer • Oklahoma City, OK, United States

    Job_description.internal_linking.related_jobs
    Remote Medical and Health Services Managers - AI Trainer ($80-$110 per hour)

    Remote Medical and Health Services Managers - AI Trainer ($80-$110 per hour)

    Mercor • Oklahoma City, Oklahoma, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    About the Role • • Mercor is seeking experienced • •medical and health services managers • • to support a leading AI lab in advancing research and infrastructure for next-generation machine learning sys...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nurse RN - Med Surg / Telemetry

    Travel Nurse RN - Med Surg / Telemetry

    Fusion Medical Staffing-Nursing • Oklahoma City, OK, US
    serp_jobs.job_card.full_time
    Fusion Medical Staffing-Nursing is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Oklahoma City, Oklahoma. Job Description & Requirements.Facility in OklahomaCity, Ok...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Remote Medical Fellows (Must be in Fellowship) - AI Trainer ($130-$130 per hour)

    Remote Medical Fellows (Must be in Fellowship) - AI Trainer ($130-$130 per hour)

    Mercor • Oklahoma City, Oklahoma, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Mercor is seeking • •clinical fellows • • across any specialty (except radiology) for a project with one of the world’s top AI labs. This project is specifically focused on medical reasoning related ca...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $658 to $958 per week in Fairview, OK

    Travel Nurse RN - Medical-Surgical - $658 to $958 per week in Fairview, OK

    TravelNurseSource • Oklahoma City, Oklahoma, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Wayward Medical Staffing to find a qualified Med / Surg RN in Fairview, Oklahoma, 73737!. LPN - Med Surg - Fairview Regional Medical Center.Core Mandatory Part II (Nu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nuclear Medicine Tech - $1,982 to $2,215 per week in Tulsa, OK

    Travel Nuclear Medicine Tech - $1,982 to $2,215 per week in Tulsa, OK

    Prime Time Healthcare • Oklahoma City, Oklahoma, US
    serp_jobs.job_card.full_time
    Now Hiring : Allied Healthcare Nuclear Medicine - Tulsa, OK.Contact us for Pay Information.Actual amount dependent upon market adjustments. Are you a passionate Allied Healthcare professional looking...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Sr. Medical Science Liaison- EPILEPSY, Texas (Remote)

    Sr. Medical Science Liaison- EPILEPSY, Texas (Remote)

    Jazz Pharmaceuticals • Oklahoma City, OK, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    AI Trainer -Freelance Content Writer

    AI Trainer -Freelance Content Writer

    Outlier • Oklahoma City, OK, United States
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nuclear Medicine Tech - $2,322 to $2,522 per week in Oklahoma City, OK

    Travel Nuclear Medicine Tech - $2,322 to $2,522 per week in Oklahoma City, OK

    Titan Medical Group • Oklahoma City, Oklahoma, US
    serp_jobs.job_card.full_time
    Travel - Nuclear Medicine Tech.Oklahoma City, OK, United States.NMTCB / BCLS / BLS - American Heart Association / ARRT(N). Titan Medical is looking for travelers to fill a Travel Nuclear Medicine Tech pos...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Physical Therapy Assistant (PTA) - $1,320 per week in Bethany, OK

    Travel Physical Therapy Assistant (PTA) - $1,320 per week in Bethany, OK

    AlliedTravelCareers • Bethany, OK, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with Marvel Medical Staffing to find a qualified Physical Therapy Assistant (PTA) in Bethany, Oklahoma, 73008!. Specialty : Physical Therapist Assistant.Setting : Outpat...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Occupational Medicine

    Occupational Medicine

    KPG Provider Services • Oklahoma City, Oklahoma, US
    serp_jobs.job_card.full_time +1
    Occupational Medicine physician job in Oklahoma : Inpatient Facility : Looking for an experienced Medical Director Occupational Medicine in the Oklahoma City, Oklahoma area.Below you will find the...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Medical Information Manager

    Medical Information Manager

    ICON • Oklahoma City, OK, US
    serp_jobs.job_card.full_time
    ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join u...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Oncology - Texas and Oklahoma - Field-based

    Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Oncology - Texas and Oklahoma - Field-based

    Eisai • Oklahoma City, OK, United States
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Remote Freelance Content Writer

    Remote Freelance Content Writer

    Outlier • Oklahoma City, OK, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Assistant Professor - Section of Infectious Diseases, Dept. of Medicine

    Assistant Professor - Section of Infectious Diseases, Dept. of Medicine

    University of Oklahoma HSC • Oklahoma City, US
    serp_jobs.job_card.full_time
    The Section of Infectious Diseases, Dept.Medicine at the University of Oklahoma Health Sciences Center (OUHSC) seeks to recruit a new faculty to the Clinician or Clinician Educator pathways at the ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Physical Therapist (PT) - $1,320 per week in Bethany, OK

    Travel Physical Therapist (PT) - $1,320 per week in Bethany, OK

    AlliedTravelCareers • Bethany, OK, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with Marvel Medical Staffing to find a qualified Physical Therapist (PT) in Bethany, Oklahoma, 73008!. Shift breakdown : 5 8-hour shifts per week.Marvel Medical Staffin...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director of the Division of Endocrinology, Diabetes and Metabolism

    Director of the Division of Endocrinology, Diabetes and Metabolism

    The University of Oklahoma College of Medicine and OU Health • Oklahoma City, US
    serp_jobs.job_card.full_time
    The University of Oklahoma College of Medicine (OUCM) Department of Internal Medicine seeks an accomplished academic endocrinologist to lead the Division of Diabetes, Endocrinology, and Metabolism....serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine - $250 to $270 per hour in Tahlequah, OK

    Locum Physician (MD / DO) - Emergency Medicine - $250 to $270 per hour in Tahlequah, OK

    LocumJobsOnline • Oklahoma City, Oklahoma, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with Lancesoft Inc to find a qualified Emergency Medicine MD in Tahlequah, Oklahoma, 74464!.Emergency Medicine or Family Medicine physicians. Days (7a–7p, 8a–8p, 10a–10p, ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Hematology-Oncology

    Hematology-Oncology

    CompHealth • Oklahoma City, Oklahoma, US
    serp_jobs.job_card.full_time
    Hematology-Oncology physician job in Oklahoma : This position is in the major metropolitan area of Oklahoma City.The city has plenty to do in its revitalized and attractive downtown, including a li...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted