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

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health / inVentiv Health Commercial LLC • Detroit, MI, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.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.

    serp_jobs.job_alerts.create_a_job

    Senior Medical Writer • Detroit, MI, United States

    Job_description.internal_linking.related_jobs
    Travel Nurse RN - Medical-Surgical - $2,000 to $2,134 per week in Saginaw, MI

    Travel Nurse RN - Medical-Surgical - $2,000 to $2,134 per week in Saginaw, MI

    TravelNurseSource • Warren, Michigan, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with RadGov, Inc to find a qualified Med / Surg RN in Saginaw, Michigan, 48601!.Travel RN Med Surg – Saginaw, MI | 13 Weeks | Gross $2,134 / week.Competitive pay, full supp...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Local Contract Certified Surgical Tech - CVOR

    Local Contract Certified Surgical Tech - CVOR

    Host Healthcare • Charter Township of Clinton, MI, US
    serp_jobs.job_card.full_time
    Host Healthcare is seeking a local contract CVOR Technologist for a local contract job in Clinton Township, Michigan.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Certified Surgical Tech - CVOR

    Travel Certified Surgical Tech - CVOR

    GHR Healthcare - PH Division • Charter Township of Clinton, MI, US
    serp_jobs.job_card.full_time
    GHR Healthcare - PH Division is seeking a travel CVOR Technologist for a travel job in Clinton Township, Michigan.Job Description & Requirements. Planet Healthcare Job ID #73737346.Pay package i...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nuclear Medicine Tech - $2,574 to $2,877 per week in Monroe, MI

    Travel Nuclear Medicine Tech - $2,574 to $2,877 per week in Monroe, MI

    Prime Time Healthcare • Warren, Michigan, US
    serp_jobs.job_card.full_time
    Now Hiring : Allied Healthcare Nuclear Medicine - Monroe, MI.Contact us for Pay Information.Actual amount dependent upon market adjustments. Are you a passionate Allied Healthcare professional lookin...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Project Manager - Medical Publications

    Project Manager - Medical Publications

    The Lockwood Group, LLC • Detroit, MI, US
    serp_jobs.job_card.temporary
    Project Manager - Medical Publications.Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Certified Surgical Tech - CVOR

    Travel Certified Surgical Tech - CVOR

    Daisy Medical Staffing • Charter Township of Clinton, MI, US
    serp_jobs.job_card.full_time
    Daisy Medical Staffing is seeking a travel CVOR Technologist for a travel job in Clinton Township, Michigan.Job Description & Requirements. Daisy Medical is looking to add a.Certified Surgical T...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical Technologist - $1,228 to $1,428 per week in Marshall, MI

    Travel Medical Technologist - $1,228 to $1,428 per week in Marshall, MI

    AlliedTravelCareers • Warren, Michigan, US
    serp_jobs.job_card.full_time +1
    AlliedTravelCareers is working with Jackson HealthPros to find a qualified Medical Technologist in Marshall, Michigan, 49068!. Jackson HealthPros is hiring a Clinical / Medical Laboratory Scientist ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Medical Technologist - $1,228 to $1,428 per week in Marshall, MI

    Travel Medical Technologist - $1,228 to $1,428 per week in Marshall, MI

    Jackson HealthPros • Warren, Michigan, US
    serp_jobs.job_card.full_time +1
    Jackson HealthPros is hiring a Clinical / Medical Laboratory Scientist (formerly Medical Technologist) to perform diagnostic testing on patient samples and analyze test results for accuracy, accept...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Nuclear Medicine Tech - $2,506 to $2,801 per week in Laurium, MI

    Travel Nuclear Medicine Tech - $2,506 to $2,801 per week in Laurium, MI

    Prime Time Healthcare • Warren, Michigan, US
    serp_jobs.job_card.full_time
    Now Hiring : Allied Healthcare Nuclear Medicine - Laurium, MI.Contact us for Pay Information.Actual amount dependent upon market adjustments. Are you a passionate Allied Healthcare professional looki...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nuclear Medicine Tech - $2,361 to $2,714 per week in West Bloomfield, MI

    Travel Nuclear Medicine Tech - $2,361 to $2,714 per week in West Bloomfield, MI

    Fusion Medical Staffing • Warren, Michigan, US
    serp_jobs.job_card.full_time
    Facility in West Bloomfield Township, Michigan.Fusion Medical Staffing is seeking a skilled Nuclear Medicine Tech for a 13-week travel assignment in West Bloomfield Township, Michigan.As a member o...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Local Contract Pathologists' Assistant

    Local Contract Pathologists' Assistant

    Talent4Health • Detroit, MI, US
    serp_jobs.job_card.full_time
    Talent4Health is seeking a local contract Pathologists' Assistant for a local contract job in Detroit, Michigan.Job Description & Requirements. Interview Format : 30-minute MS Teams interview...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Hematology and Oncology - $500 to $510 per hour in Grand Rapids, MI

    Locum Physician (MD / DO) - Hematology and Oncology - $500 to $510 per hour in Grand Rapids, MI

    LocumJobsOnline • Warren, Michigan, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with Lancesoft Inc to find a qualified Hematology and Oncology MD in Grand Rapids, Michigan, 49501!. Grand Rapids, Michigan, seeking a.Board-Certified Hematologist-Oncolog...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $2,420 per week in Spokane, MI

    Travel Nurse RN - Medical-Surgical - $2,420 per week in Spokane, MI

    TravelNurseSource • Warren, Michigan, US
    serp_jobs.job_card.full_time +1
    TravelNurseSource is working with Lancesoft Inc to find a qualified Med / Surg RN in Spokane, Michigan, 65754!.Provide comprehensive nursing care to med-surg patients across multiple units.Collaborat...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Medical Director, Medical Affairs, Neurology - U.S. - Remote

    Senior Medical Director, Medical Affairs, Neurology - U.S. - Remote

    Worldwide Clinical Trials • Lasalle, Essex County, Canada
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Senior Medical Director, Medical Affairs, Neurology – U.Be among the first 25 applicants.We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for th...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Hematology and Oncology in Grand Rapids, MI

    Locum Physician (MD / DO) - Hematology and Oncology in Grand Rapids, MI

    LocumJobsOnline • Warren, Michigan, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with CompHealth to find a qualified Hematology and Oncology MD in Grand Rapids, Michigan, 49503!. CompHealth services are always free to you.Let us do the heavy lifting an...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Nuclear Medicine Tech - $2,436 to $2,636 per week in Flint, MI

    Travel Nuclear Medicine Tech - $2,436 to $2,636 per week in Flint, MI

    Titan Medical Group • Warren, Michigan, US
    serp_jobs.job_card.full_time
    Travel - Nuclear Medicine Tech.NMTCB / ARRT(N) / BCLS / BLS - American Heart Association.Titan Medical is looking for travelers to fill a Travel Nuclear Medicine Tech position for a 13 week assignment in...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nuclear Medicine Tech - $2,196 to $2,396 per week in Lansing, MI

    Travel Nuclear Medicine Tech - $2,196 to $2,396 per week in Lansing, MI

    Titan Medical Group • Warren, Michigan, US
    serp_jobs.job_card.full_time
    Travel - Nuclear Medicine Tech.NMTCB / BCLS / BLS - American Heart Association / ARRT(N).Titan Medical is looking for travelers to fill a Travel Nuclear Medicine Tech position for a 13 week assignment in...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Medical Technologist - $1,228 to $1,428 per week in Marshall, MI

    Travel Medical Technologist - $1,228 to $1,428 per week in Marshall, MI

    AlliedTravelNetwork • Detroit, Michigan, US
    serp_jobs.job_card.full_time +1
    AlliedTravelNetwork is working with Jackson HealthPros to find a qualified Medical Technologist in Marshall, Michigan, 49068!. Jackson HealthPros is hiring a Clinical / Medical Laboratory Scientist ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted