Talent.com
Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

Syneos Health / inVentiv Health Commercial LLCWashington, DC, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

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

Job responsibilities

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Acts as lead for assigned writing projects.
  • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
  • Develops or supports a variety of documents that include, but not limited to :
  • Clinical study protocols and clinical protocol amendments;

  • Clinical study reports;
  • Patient narratives;
  • Clinical development plans;
  • IND submissions and annual reports;
  • Integrated summary reports;
  • NDA and (e)CTD submissions;
  • Investigator brochures, as well as;
  • Clinical journal manuscripts, clinical journal abstracts, and client presentations.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Reviews statistical analysis plans and table / figure / listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Serves as peer reviewer on internal review team providing review comments on draft and final documents.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and / or client approved templates when completing medical writing projects, on-time and on-budget.
  • Performs on-line clinical literature searches, as applicable.
  • Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
  • Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
  • Completes required administrated tasks within the specified timeframes.
  • Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
  • Qualifications
  • What we're looking for

    Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and / or medical knowledge and expertise.

  • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
  • Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
  • 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

    Medical Writer • Washington, DC, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Freelance Medical Writer

    Freelance Medical Writer

    Direct Response Consulting ServicesAshburn, VA, United States
    serp_jobs.job_card.full_time
    Freelance Medical Writer (Alzheimer’s / Dementia and / or Cancer Expertise | MD or PhD Required).Remote | Contractor | As-Needed Basis. We’re seeking an experienced freelance writer with a medical or sc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.new
    Gilead Sciences, Inc. is hiring : Senior Manager, Medical Writing, Oncology in Wa

    Gilead Sciences, Inc. is hiring : Senior Manager, Medical Writing, Oncology in Wa

    MediabistroWashington, DC, United States
    serp_jobs.job_card.full_time +1
    Senior Manager, Medical Writing, Oncology.Senior Manager, Medical Writing, Oncology.United States – Remote Regulatory Regular. At Gilead, we’re creating a healthier world for all people.For more tha...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Pathology in Maryland

    Locum Physician (MD / DO) - Pathology in Maryland

    LocumJobsOnlineColumbia, Maryland, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with All Star Healthcare Solutions to find a qualified Pathology MD in Maryland!.AP / CP Pathologist position in Maryland less than an hour to Wash DC .BC / BE in AP / CP - a s...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Lead Clinical RN - Med / Surg

    Lead Clinical RN - Med / Surg

    Johns Hopkins MedicineColumbia, MD, US
    serp_jobs.job_card.full_time
    Johns Hopkins Howard County Medical Center is a private, not-for-profit, community health care provider, governed by a community-based board of trustees. Since its founding in 1973, the original 59-...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

    Syneos Health / inVentiv Health Commercial LLCBaltimore, MD, United States
    serp_jobs.job_card.full_time
    Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased).Syneos Health is a leading fully integrated biopharmaceutical solutions organization b...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Hematology and Oncology - $325 to $350 per hour in Towson, MD

    Locum Physician (MD / DO) - Hematology and Oncology - $325 to $350 per hour in Towson, MD

    LocumJobsOnlineColumbia, Maryland, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with Curative to find a qualified Hematology and Oncology MD in Towson, Maryland, 21204!.Hematology-Oncology Locums in Maryland - 4-Day Clinic Week.Are you a Hematologist...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Travel Nurse RN - Medical-Surgical - $1,720 to $1,873 per week in Towson, MD

    Travel Nurse RN - Medical-Surgical - $1,720 to $1,873 per week in Towson, MD

    TravelNurseSourceGermantown, Maryland, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Host Healthcare to find a qualified Med / Surg RN in Towson, Maryland, 21204!.Host Healthcare is an award-winning travel healthcare company with an immediate opening...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    Senior Medical Writer (Remote)

    Senior Medical Writer (Remote)

    MMSBaltimore, MD, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.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...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Travel Registered Nurse - Medical-Surgical in Bowie, MD

    Travel Registered Nurse - Medical-Surgical in Bowie, MD

    TravelNurseSourceColumbia, Maryland, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Titan Medical Group to find a qualified Med / Surg RN in Bowie, Maryland, 20715!.Titan Medical is looking for travelers to fill a Travel Med Surg position for a 14 w...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Travel Nurse RN - Medical-Surgical in Bowie, MD

    Travel Nurse RN - Medical-Surgical in Bowie, MD

    TravelNurseSourceColumbia, Maryland, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Titan Medical Group to find a qualified Med / Surg RN in Bowie, Maryland, 20715!.Titan Medical is looking for travelers to fill a Travel Med Surg position for a 14 w...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLCWashington, DC, United States
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Cedent Consulting is hiring : Senior Medical Writer in Rockville

    Cedent Consulting is hiring : Senior Medical Writer in Rockville

    MediabistroRockville, MD, United States
    serp_jobs.job_card.full_time
    The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Travel Nurse RN - Medical-Surgical - $1,625 to $1,801 per week in Leonardtown, MD

    Travel Nurse RN - Medical-Surgical - $1,625 to $1,801 per week in Leonardtown, MD

    TravelNurseSourceColumbia, Maryland, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with LRS Healthcare to find a qualified Med / Surg RN in Leonardtown, Maryland, 20650!.Ready to start your next travel adventure? LRS Healthcare offers a full benefits pa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Freelance Medical Writer (Ashburn)

    Freelance Medical Writer (Ashburn)

    Direct Response Consulting ServicesAshburn, VA, US
    serp_jobs.job_card.part_time
    Freelance Medical Writer (Alzheimers / Dementia and / or Cancer Expertise | MD or PhD Required).Remote | Contractor | As-Needed Basis. Were seeking an experienced freelance writer with a medical or scie...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Sr Medical Writer (Regulatory Documents)

    Sr Medical Writer (Regulatory Documents)

    Syneos Health / inVentiv Health Commercial LLCWashington, DC, United States
    serp_jobs.job_card.full_time
    Sr Medical Writer (Regulatory Documents).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse - RN - LD - Labor and Delivery - $2208 / Week

    Travel Nurse - RN - LD - Labor and Delivery - $2208 / Week

    Fusion Medical StaffingUpper Marlboro, MD, US
    serp_jobs.job_card.full_time
    Fusion Medical Staffing is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Upper Marlboro, MD. Shift : Inquire Start Date : 10 / 06 / 2025 Duration : 18 wee...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Nurse Practitioner (NP) - Hematology and Oncology - $70 to $90 per hour in Maryland

    Locum Nurse Practitioner (NP) - Hematology and Oncology - $70 to $90 per hour in Maryland

    LocumJobsOnlineColumbia, Maryland, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with Lancesoft Inc to find a qualified Hematology and Oncology NP in Maryland!.A Health Cancer Center is actively seeking a skilled. You will collaborate with a team inclu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Travel Nurse RN - Medical-Surgical - $1,615 to $1,791 per week in Leonardtown, MD

    Travel Nurse RN - Medical-Surgical - $1,615 to $1,791 per week in Leonardtown, MD

    TravelNurseSourceColumbia, Maryland, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with LRS Healthcare to find a qualified Med / Surg RN in Leonardtown, Maryland, 20650!.Ready to start your next travel adventure? LRS Healthcare offers a full benefits pa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Travel Nurse - RN - LD - Labor and Delivery - $2208 / Week - Hiring Now

    Travel Nurse - RN - LD - Labor and Delivery - $2208 / Week - Hiring Now

    Fusion Medical StaffingUpper Marlboro, MD, US
    serp_jobs.job_card.full_time
    Fusion Medical Staffing is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Upper Marlboro, MD. Shift : Inquire Start Date : 10 / 06 / 2025 Duration : 18 wee...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Nurse Practitioner (NP) - Hematology and Oncology - $160 per hour in Maryland

    Locum Nurse Practitioner (NP) - Hematology and Oncology - $160 per hour in Maryland

    LocumJobsOnlineColumbia, Maryland, US
    serp_jobs.job_card.full_time
    LocumJobsOnline is working with Lancesoft Inc to find a qualified Hematology and Oncology NP in Maryland!.Looking for a high-paying outpatient role with no inpatient call and a supportive multidisc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30