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 LLCIndianapolis, IN, United States
job_description.job_card.1_day_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 • Indianapolis, IN, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Travel Nurse RN - ED - Emergency Department

    Travel Nurse RN - ED - Emergency Department

    Planet HealthcareFranklin, IN, US
    serp_jobs.job_card.full_time
    Planet Healthcare is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Franklin, Indiana.Job Description & Requirements. Planet Healthcare Job ID #73075954.Pay pack...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Labor and Delivery

    Travel Nurse RN - Labor and Delivery

    GLC On-The-GoAvon, IN, US
    serp_jobs.job_card.full_time
    GLC On-The-Go is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Avon, Indiana.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 hours per wee...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Travel Nurse RN - ED - Emergency Department

    Travel Nurse RN - ED - Emergency Department

    Uniti MedFranklin, IN, US
    serp_jobs.job_card.full_time
    Uniti Med is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Franklin, Indiana.Job Description & Requirements. Uniti Med is looking for a Travel Emergency Room RN...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Hematology Oncology Locums December

    Hematology Oncology Locums December

    JobotZionsville, IN, US
    serp_jobs.job_card.full_time
    Hematology Oncology Locums December 1st - July 1st.This Jobot Consulting Job is hosted by : Ryan Matias.Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Travel Labor and Delivery RN

    Travel Labor and Delivery RN

    Ethos Medical StaffingFishers, IN, US
    serp_jobs.job_card.full_time
    Ethos Medical Staffing is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Fishers, Indiana.Job Description & Requirements. Ethos Medical Staffing Job ID #34244073.Pay pa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Sr Medical Writer (Regulatory Documents)

    Sr Medical Writer (Regulatory Documents)

    Syneos Health / inVentiv Health Commercial LLCIndianapolis, IN, 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
    • serp_jobs.job_card.new
    Travel Nurse RN - ED - Emergency Department

    Travel Nurse RN - ED - Emergency Department

    First Connect HealthFranklin, IN, US
    serp_jobs.job_card.full_time
    First Connect Health is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Franklin, Indiana. Job Description & Requirements.Have worked with Cerner in the last year...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Local Contract Nurse RN - Labor and Delivery

    Local Contract Nurse RN - Labor and Delivery

    Host HealthcareFranklin, IN, US
    serp_jobs.job_card.full_time
    Host Healthcare is seeking a local contract nurse RN Labor and Delivery for a local contract nursing job in Franklin, Indiana. Job Description & Requirements.Pay package is based on 12 hour shif...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Travel Nurse RN - OR - $2,167 to $2,260 per week in Fishers, IN

    Travel Nurse RN - OR - $2,167 to $2,260 per week in Fishers, IN

    TravelNurseSourceFishers, IN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Greenstaff Medical to find a qualified OR RN in Fishers, Indiana, 46037!.Why Choose Greenstaff Medical US?. Your Trusted Partner in Healthcare Staffing.At Greenstaf...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLCIndianapolis, IN, United States
    serp_jobs.job_card.full_time
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - ED - Emergency Department - $2,268 per week

    Travel Nurse RN - ED - Emergency Department - $2,268 per week

    GHR Healthcare - Travel DivisionFranklin, IN, United States
    serp_jobs.job_card.full_time
    GHR Healthcare - Travel Division is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Franklin, Indiana. Job Description & Requirements.GHR Healthcare - Travel Divisio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Local Contract Nurse RN - ICU - Intensive Care Unit

    Local Contract Nurse RN - ICU - Intensive Care Unit

    LanceSoftColumbus, IN, US
    serp_jobs.job_card.permanent
    LanceSoft is seeking a local contract nurse RN ICU - Intensive Care Unit for a local contract nursing job in Columbus, Indiana. Job Description & Requirements.Associate of Nursing (ASN) or equiv...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • 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 LLCIndianapolis, IN, 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_1_day
    • serp_jobs.job_card.promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLCIndianapolis, IN, United States
    serp_jobs.job_card.full_time
    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 ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Nonclinical Writer

    Nonclinical Writer

    MMSZionsville, IN, US
    serp_jobs.job_card.full_time
    Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical resea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    CT Scan Technologist

    CT Scan Technologist

    AscensionAnderson, IN, United States
    serp_jobs.job_card.full_time
    Various health insurance options & wellness plans.Retirement benefits including employer match plans.Long-term & short-term disability. Employee assistance programs (EAP).Parental leave & adoption a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Nurse RN - ED - Emergency Department - $2,268 per week

    Travel Nurse RN - ED - Emergency Department - $2,268 per week

    GHR HealthcareFranklin, IN, United States
    serp_jobs.job_card.full_time
    GHR Healthcare is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Franklin, Indiana.Job Description & Requirements. GHR Healthcare Job ID #73075954.Pay package is bas...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    Otsuka America Pharmaceutical Inc. is hiring : Senior Manager Medical Writing in

    Otsuka America Pharmaceutical Inc. is hiring : Senior Manager Medical Writing in

    MediabistroIndianapolis, IN, United States
    serp_jobs.job_card.full_time
    The Senior Manager, Medical Writing (MW) will be responsible for leading and advising on medical writing processes and activities for individual asset teams to which they are assigned.The Senior Ma...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours