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

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health / inVentiv Health Commercial LLC • Santa Monica, CA, 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 • Santa Monica, CA, United States

    Related jobs
    Travel Nuclear Medicine Tech - $2,986 to $3,173 per week in Burbank, CA

    Travel Nuclear Medicine Tech - $2,986 to $3,173 per week in Burbank, CA

    AlliedTravelCareers • Burbank, CA, US
    Full-time +1
    AlliedTravelCareers is working with Aya Healthcare to find a qualified Nuclear Medicine Tech in Burbank, California, 91501!. Aya Healthcare has an immediate opening for the following position : Nucle...Show more
    Last updated: 25 days ago • Promoted
    Travel Nuclear Medicine Technologist - $3,175 per week

    Travel Nuclear Medicine Technologist - $3,175 per week

    First Connect Health • Burbank, CA, United States
    Full-time
    First Connect Health is seeking a travel Nuclear Medicine Technologist for a travel job in Burbank, California.Job Description & Requirements. School of Radiologic Technology.School of Nuclear Medic...Show more
    Last updated: 20 days ago • Promoted
    Travel Medical Technologist - $2,353 to $2,608 per week in Burlingame, CA

    Travel Medical Technologist - $2,353 to $2,608 per week in Burlingame, CA

    LRS Healthcare • Los Angeles, California, US
    Full-time
    Ready to start your next travel adventure? LRS Healthcare offers a full benefits package, 24 / 7 support, and a responsive, traveler-first culture. What are you waiting for? Apply today!.Valid license...Show more
    Last updated: 7 days ago • Promoted
    Emergency Medicine (Full-time)

    Emergency Medicine (Full-time)

    Kaiser Permanente – Southern California Permanente Medical Group • Panorama City, US
    Full-time +1
    Salary range includes incentives that are contingent upon skills, competencies, longevity, experience and geographic location. The earnings included in the salary range are contingent upon requisite...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nuclear Medicine Tech - $2,481 to $2,751 per week in Burbank, CA

    Travel Nuclear Medicine Tech - $2,481 to $2,751 per week in Burbank, CA

    AlliedTravelCareers • Burbank, CA, US
    Full-time
    AlliedTravelCareers is working with LRS Healthcare to find a qualified Nuclear Medicine Tech in Burbank, California, 91505!. Ready to start your next travel adventure? LRS Healthcare offers a full b...Show more
    Last updated: 30+ days ago • Promoted
    Prior Authorization Medical Director Physician- Los Angeles, CA Area - Work From Home

    Prior Authorization Medical Director Physician- Los Angeles, CA Area - Work From Home

    Curative • Los Angeles, CA, US
    Remote
    Full-time
    Prior Authorization Medical Director Physician Opportunity in the Los Angeles Area.Please consider this unique opportunity to join a well-established and respected group of innovators in value-base...Show more
    Last updated: 28 days ago • Promoted
    Travel Nuclear Medicine Tech - $2,481 to $2,751 per week in Burbank, CA

    Travel Nuclear Medicine Tech - $2,481 to $2,751 per week in Burbank, CA

    LRS Healthcare • Burbank, CA, US
    Full-time
    Ready to start your next travel adventure? LRS Healthcare offers a full benefits package, 24 / 7 support, and a responsive, traveler-first culture. What are you waiting for? Apply today!.Valid license...Show more
    Last updated: 19 days ago • Promoted
    Travel Nuclear Medicine Tech - $2,481 to $2,751 per week in Burbank, CA

    Travel Nuclear Medicine Tech - $2,481 to $2,751 per week in Burbank, CA

    AlliedTravelNetwork • Burbank, CA, US
    Full-time
    AlliedTravelNetwork is working with LRS Healthcare to find a qualified Nuclear Medicine Tech in Burbank, California, 91505!. Ready to start your next travel adventure? LRS Healthcare offers a full b...Show more
    Last updated: 19 days ago • Promoted
    Senior Writer

    Senior Writer

    Solugenix Corp • Los Angeles, CA, US
    Temporary
    Senior Writer Los Angeles, CA (Hybrid) 12-Month Contract Job ID 25-09853 Solugenix is assisting a client, a prestigious and large investment management company in their search for a Senior Writer.T...Show more
    Last updated: 14 days ago • Promoted
    Principal Medical Publications Writer

    Principal Medical Publications Writer

    ImmunityBio • Culver City, CA, United States
    Full-time
    NASDAQ : IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling ...Show more
    Last updated: 30+ days ago • Promoted
    Immunology Sales Specialist

    Immunology Sales Specialist

    Syneos Health / inVentiv Health Commercial LLC • North Hollywood, CA, United States
    Full-time
    You have what it takes : a competitive drive coupled with exceptional sales ability.In this role, you will be responsible for implementing the sales plan by delivering proficient sales presentations...Show more
    Last updated: 27 days ago • Promoted
    Postdoctoral Scientist - Program on Internet, Health, and Society

    Postdoctoral Scientist - Program on Internet, Health, and Society

    CEDARS-SINAI • Beverly Hills, CA, US
    Full-time
    Job Description The Cedars-Sinai Center for the Arts and Humanities in Medicine is looking for a Postdoctoral Scientist to join the team! &l...Show more
    Last updated: 19 hours ago • Promoted • New!
    Travel Nuclear Medicine Tech - $2,340 to $2,615 per week in Burbank, CA

    Travel Nuclear Medicine Tech - $2,340 to $2,615 per week in Burbank, CA

    AlliedTravelNetwork • Burbank, CA, US
    Full-time
    AlliedTravelNetwork is working with Prime Time Healthcare to find a qualified Nuclear Medicine Tech in Burbank, California, 91501!. Now Hiring : Allied Healthcare Nuclear Medicine - Burbank, CA.Conta...Show more
    Last updated: 11 days ago • Promoted
    Medical Director - Post-Acute Care Management - Care Transitions - Remote anywhere in US

    Medical Director - Post-Acute Care Management - Care Transitions - Remote anywhere in US

    UnitedHealth Group • Los Angeles, CA, United States
    Remote
    Full-time
    Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives.The work you do with our team will directly improve health outcomes by connect...Show more
    Last updated: 14 days ago • Promoted
    Writer / Journalist Internship Part-Time in Worldwide - Remote Worldwide

    Writer / Journalist Internship Part-Time in Worldwide - Remote Worldwide

    The Borgen Project • Burbank, CA, United States
    Remote
    Part-time +1
    Are you passionate about making a difference in the world? Look no further! The Borgen Project is an international organization that works at the political level to improve living conditions for pe...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nuclear Medicine Technologist - $3,250 per week

    Travel Nuclear Medicine Technologist - $3,250 per week

    First Connect Health • Burbank, CA, United States
    Full-time
    First Connect Health is seeking a travel Nuclear Medicine Technologist for a travel job in Burbank, California.Job Description & Requirements. Years of experience REQ : 1 year.Certs REQ : BLS, ARRT or...Show more
    Last updated: 23 days ago • Promoted
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • Santa Monica, CA, United States
    Full-time
    Principal Medical Writer - Regulatory Submission Documents.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate uni...Show more
    Last updated: 8 days ago • Promoted
    Anesthesiology - Medical Director / Vice Chair

    Anesthesiology - Medical Director / Vice Chair

    Trinity Health • Maywood, US
    Full-time
    The Department of Anesthesiology and Perioperative Medicine at Loyola University Chicago (LUC) Stritch School of Medicine is currently recruiting a Medical Director / Vice Chair to oversee Anesthesio...Show more
    Last updated: 30+ days ago • Promoted