Talent.com
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor
Senior Principal Medical Writer - Regulatory - Oncology - Single SponsorSyneos Health/ inVentiv Health Commercial LLC • Fargo, ND, United States
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health / inVentiv Health Commercial LLC • Fargo, ND, United States
30+ days ago
Job type
  • Full-time
Job description

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

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, 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.
  • Participate in cross-functional process improvement initiatives.
  • Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
  • Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
  • Mentor more junior medical writing staff.
  • At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions / bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

    Salary Range :

    $114,000.00 - $210,900.00

    The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

    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

    Senior Medical Writer • Fargo, ND, United States

    Related jobs
    Principal / Sr Medical Writer (Regulatory & Publications)

    Principal / Sr Medical Writer (Regulatory & Publications)

    Syneos Health / inVentiv Health Commercial LLC • Fargo, ND, United States
    Full-time
    Principal / Sr Medical Writer (Regulatory & Publications).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique...Show more
    Last updated: 2 days ago • Promoted
    RN Inpatient- Behavioral & Medical Unit - Part Time

    RN Inpatient- Behavioral & Medical Unit - Part Time

    Sanford Health • Fargo, ND, US
    Full-time +1
    As one of the largest not-for-profit health systems in the United States, Sanford Health is always looking to innovate and grow. Grow with us by joining our team of over 18,000 nurses.Our workplace ...Show more
    Last updated: 22 hours ago • Promoted • New!
    Travel Registered Nurse (RN) - Long-Term Care (LTC) - $1,560 per week in Ada, MN

    Travel Registered Nurse (RN) - Long-Term Care (LTC) - $1,560 per week in Ada, MN

    TravelNurseSource • Ada, MN, US
    Full-time +1
    TravelNurseSource is working with Core Medical Group to find a qualified Long-Term Care RN in Ada, Minnesota, 56510!.Client in MN seeking Registered Nurse : LTC / SNF. We are looking for a healthcare p...Show more
    Last updated: 5 days ago • Promoted
    RN - Urology Clinic

    RN - Urology Clinic

    Sanford Health • Fargo, ND, US
    Full-time +1
    Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States.We're proud to offer many development and advancement opportunities to our nearly 50,000 ...Show more
    Last updated: 2 days ago • Promoted
    RN Inpatient - North Network

    RN Inpatient - North Network

    Sanford Health • Hillsboro, ND, US
    Full-time +1
    As one of the largest not-for-profit health systems in the United States, Sanford Health is always looking to innovate and grow. Grow with us by joining our team of over 18,000 nurses.Our workplace ...Show more
    Last updated: 22 hours ago • Promoted • New!
    Travel Nurse RN - ER

    Travel Nurse RN - ER

    Titan Medical Group • Grandin, ND, US
    Full-time
    WHEN YOU WORK FOR US, WE WORK FOR YOU\n.With Titan Medical, you gain access to thousands of travel nursing and allied health jobs across the country. You also get unmatched service.From the moment y...Show more
    Last updated: 1 day ago • Promoted
    Sleep Technologist

    Sleep Technologist

    SLEEP RX LLC • Horace, ND, US
    Full-time
    Polysomnographic Technologist (RPSGT) or Respiratory Therapist (RRT).Pay : $35 to $55 dollars per hour.Schedule : Full-time, 34 nights per week, 8 : 00 PM6 : 00 AM. Job Description and Position Overview : ....Show more
    Last updated: 30+ days ago • Promoted
    Registered Nurse - RN - Local Traveler

    Registered Nurse - RN - Local Traveler

    Good Samaritan • Barnesville, MN, US
    Full-time +2
    Join our not-for-profit organization that has provided over 100 years of housing and services to seniors with a commitment to quality care and service in a Christian environment.Glenhaven Dr, Battl...Show more
    Last updated: 22 hours ago • Promoted • New!
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLC • Fargo, ND, 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 more
    Last updated: 30+ days ago • Promoted
    RN - Medical Oncology Clinic - Roger Maris Cancer Center

    RN - Medical Oncology Clinic - Roger Maris Cancer Center

    Sanford Health • Fargo, ND, US
    Full-time +1
    Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States.We're proud to offer many development and advancement opportunities to our nearly 50,000 ...Show more
    Last updated: 4 days ago • Promoted
    Physical Therapist

    Physical Therapist

    Encompass Health • Shelly, MN, US
    Full-time +1
    Join a Team That Puts Your Passion for Care First.Are you seeking a fulfilling career that feels like home and lets you make a meaningful impact? At Encompass Health, you'll find an opportunity to ...Show more
    Last updated: 18 hours ago • Promoted • New!
    Restaurant Delivery - Sign Up and Start Earning

    Restaurant Delivery - Sign Up and Start Earning

    DoorDash • Barnesville, MN, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show more
    Last updated: 1 day ago • Promoted
    Dashers - Sign Up and Start Earning

    Dashers - Sign Up and Start Earning

    DoorDash • Barnesville, MN, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show more
    Last updated: 1 day ago • Promoted
    Travel Licensed Practical / Licensed Vocational Nurse (LPN / LVN) - Long-Term Care (LTC) - $955 to $1,059 per week in Hillsboro, ND

    Travel Licensed Practical / Licensed Vocational Nurse (LPN / LVN) - Long-Term Care (LTC) - $955 to $1,059 per week in Hillsboro, ND

    TravelNurseSource • Hillsboro, ND, US
    Full-time
    TravelNurseSource is working with LRS Healthcare to find a qualified Long-Term Care LPN / LVN in Hillsboro, North Dakota, 58045!. Ready to start your next travel adventure? LRS Healthcare offers a f...Show more
    Last updated: 5 days ago • Promoted
    Travel Nurse - LPN - LTC - Long Term Care

    Travel Nurse - LPN - LTC - Long Term Care

    CrossMed Healthcare • Hillsboro, ND, US
    Full-time
    CrossMed Healthcare is seeking an experienced Long Term Care Licensed Practical Nurse for an exciting Travel Nursing job in Hillsboro, ND. Shift : Inquire Start Date : ASAP Duration : 26 weeks.At Cross...Show more
    Last updated: 26 days ago • Promoted
    Delivery Driver - Sign Up and Start Earning

    Delivery Driver - Sign Up and Start Earning

    DoorDash • Barnesville, MN, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show more
    Last updated: 1 day ago • Promoted
    Licensed Practical Nurse - LPN - Local Traveler

    Licensed Practical Nurse - LPN - Local Traveler

    Good Samaritan • Barnesville, Mn, Clay County, MN; Minnesota, US
    Full-time +2
    Join our not-for-profit organization that has provided over 100 years of housing and services to seniors with a commitment to quality care and service in a Christian environment.Glenhaven Dr, Battl...Show more
    Last updated: 22 hours ago • Promoted • New!
    RN - Hillsboro Medical Center - Full Time

    RN - Hillsboro Medical Center - Full Time

    Sanford Health • Hillsboro, ND, US
    Full-time +1
    As one of the largest not-for-profit health systems in the United States, Sanford Health is always looking to innovate and grow. Grow with us by joining our team of over 18,000 nurses.Our workplace ...Show more
    Last updated: 15 hours ago • Promoted • New!