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 LLCWichita, KS, United States
7 days ago
Job type
  • Full-time
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.

    Create a job alert for this search

    Medical Writer • Wichita, KS, United States

    Related jobs
    • Promoted
    Travel Nurse RN - Labor and Delivery

    Travel Nurse RN - Labor and Delivery

    Genie HealthcareWinfield, KS, US
    Full-time
    Genie Healthcare is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Winfield, Kansas.Job Description & Requirements. Genie Healthcare Job ID #17222971.Pay package is bas...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Emergency Room Registered Nurse

    Travel Emergency Room Registered Nurse

    Zack GroupWinfield, KS, US
    Permanent
    Zack Group is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Winfield, Kansas.Job Description & Requirements. ER RN’s for positions in Winfield, Kansas.The...Show moreLast updated: 30+ days ago
    • Promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLCWichita, KS, United States
    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 ...Show moreLast updated: 14 days ago
    • Promoted
    Travel Nurse RN - Labor and Delivery

    Travel Nurse RN - Labor and Delivery

    Malone Healthcare - NursingWinfield, KS, US
    Full-time
    Malone Healthcare - Nursing is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Winfield, Kansas. Job Description & Requirements.About Malone Healthcare - Nursing.With a ...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Nurse RN - ED - Emergency Department - $1,246 per week

    Travel Nurse RN - ED - Emergency Department - $1,246 per week

    Amergis Healthcare Staffing, Inc.Winfield, KS, United States
    Full-time
    Amergis Healthcare Staffing, Inc.RN ED - Emergency Department for a travel nursing job in Winfield, Kansas.Job Description & Requirements. We are hiring a qualified Kansas Registered Nurse to work i...Show moreLast updated: 1 day ago
    • Promoted
    Travel Nurse RN - ED - Emergency Department - $1,959 per week

    Travel Nurse RN - ED - Emergency Department - $1,959 per week

    MedPro Healthcare StaffingWinfield, KS, United States
    Full-time
    MedPro Healthcare Staffing is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Winfield, Kansas. Job Description & Requirements.Joint Commission-certified staffing age...Show moreLast updated: 7 days ago
    • Promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLCWichita, KS, United States
    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...Show moreLast updated: 7 days ago
    • Promoted
    Locum Physician (MD / DO) - Radiology - General / Other in Newton, KS

    Locum Physician (MD / DO) - Radiology - General / Other in Newton, KS

    LocumJobsOnlineNewton, KS, US
    Full-time
    LocumJobsOnline is working with CompHealth to find a qualified Radiology MD in Newton, Kansas, 67114!.Though your CompHealth recruiter will be your single point of contact, they are backed by dozen...Show moreLast updated: 28 days ago
    • Promoted
    Travel Nurse RN - ED - Emergency Department

    Travel Nurse RN - ED - Emergency Department

    TrustaffWinfield, KS, US
    Full-time
    Trustaff is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Winfield, Kansas.Job Description & Requirements. As an Emergency Room RN, you'll provide care for ...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Nurse RN - Labor and Delivery

    Travel Nurse RN - Labor and Delivery

    Innovent GlobalWinfield, KS, US
    Full-time +2
    Innovent Global is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Winfield, Kansas.Job Description & Requirements. Pay package is based on 12 hour shifts and 36 hours p...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Medical / Surgical RN

    Travel Medical / Surgical RN

    Anders GroupWichita, KS, US
    Full-time
    Anders Group is seeking a travel nurse RN Med Surg for a travel nursing job in Wichita, Kansas.Job Description & Requirements. Pay package is based on 12 hour shifts and 36 hours per week (subje...Show moreLast updated: 30+ days ago
    • Promoted
    Locum Physician (MD / DO) - Radiology - General / Other in Hesston, KS

    Locum Physician (MD / DO) - Radiology - General / Other in Hesston, KS

    LocumJobsOnlineHesston, KS, US
    Full-time
    LocumJobsOnline is working with Aya Locums to find a qualified Radiology MD in Hesston, Kansas, 67062!.Aya Locums has an immediate opening for a locum Radiology job in Hesston, KS paying $3000 / day-...Show moreLast updated: 28 days ago
    • 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 LLCWichita, KS, United States
    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 ...Show moreLast updated: 8 days ago
    Sr Principal / Principal Medical Writer - East Coast Preferred - Single Sponsor

    Sr Principal / Principal Medical Writer - East Coast Preferred - Single Sponsor

    MediabistroWichita, KS, United States
    Full-time
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single SponsorSyneos Health is a leading fully integrated biopharmaceutical solutions organization b...Show moreLast updated: 7 days ago
    • Promoted
    Locum Physician (MD / DO) - Anesthesiology - General / Other in Newton, KS

    Locum Physician (MD / DO) - Anesthesiology - General / Other in Newton, KS

    LocumJobsOnlineNewton, KS, US
    Full-time +1
    LocumJobsOnline is working with Aya Locums to find a qualified Anesthesiology MD in Newton, Kansas, 67114!.Aya Locums has an immediate opening for a locum Certified Registered Nurse Anesthetist (CR...Show moreLast updated: 28 days ago
    • Promoted
    Locum Certified Registered Nurse Anesthetist (CRNA) - Anesthesiology - General / Other in Newton, KS

    Locum Certified Registered Nurse Anesthetist (CRNA) - Anesthesiology - General / Other in Newton, KS

    LocumJobsOnlineNewton, KS, US
    Full-time
    LocumJobsOnline is working with LocumTenens.Anesthesiology CRNA in Newton, Kansas, 67114!.Job Reference Id : ORD-196858-CRNA-KS. Board Certification Required : Yes.A beautiful facility is seeking a ...Show moreLast updated: 18 days ago
    • Promoted
    Travel Nurse RN - ED - Emergency Department

    Travel Nurse RN - ED - Emergency Department

    MedPro Healthcare StaffingWinfield, KS, US
    Full-time
    MedPro Healthcare Staffing is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Winfield, Kansas. Job Description & Requirements.Joint Commission-certified staffing...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Emergency Room Registered Nurse

    Travel Emergency Room Registered Nurse

    Care CareerWinfield, KS, US
    Full-time
    Care Career is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Winfield, Kansas.Job Description & Requirements. Emergency Room Nurses (RN) are responsible to trea...Show moreLast updated: 30+ days ago
    • Promoted
    Locum Certified Registered Nurse Anesthetist (CRNA) - Anesthesiology - General / Other in Newton, KS

    Locum Certified Registered Nurse Anesthetist (CRNA) - Anesthesiology - General / Other in Newton, KS

    LocumJobsNetworkNewton, KS, US
    Full-time
    LocumJobsNetwork is working with LocumTenens.Anesthesiology CRNA in Newton, Kansas, 67114!.Job Reference Id : ORD-196858-CRNA-KS. Board Certification Required : Yes.A beautiful facility is seeking a...Show moreLast updated: 18 days ago
    • Promoted
    Locum Certified Registered Nurse Anesthetist (CRNA) - General Practice in Newton, KS

    Locum Certified Registered Nurse Anesthetist (CRNA) - General Practice in Newton, KS

    LocumJobsOnlineNewton, KS, US
    Full-time +2
    LocumJobsOnline is working with GHR Healthcare to find a qualified General Practice CRNA in Newton, Kansas, 67114!.Locum CRNA Opportunity at a Facility in Kansas - CRNA Only Practice.Nov 3 - 14, No...Show moreLast updated: 30+ days ago