Talent.com
serp_jobs.error_messages.no_longer_accepting
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health / inVentiv Health Commercial LLCVirginia Beach, VA, 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

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 • Virginia Beach, VA, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $2,016 to $2,102 per week in Lyychburg, VA

    Travel Nurse RN - Medical-Surgical - $2,016 to $2,102 per week in Lyychburg, VA

    TravelNurseSourceChesapeake, Virginia, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Greenstaff Medical to find a qualified Med / Surg RN in Lyychburg, Virginia, 24501!.Why Choose Greenstaff Medical US?. Your Trusted Partner in Healthcare Staffing.At ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Associate Medical Director

    Associate Medical Director

    ChenMedVirginia Beach, VA, United States
    serp_jobs.job_card.full_time
    We’re changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Local Contract Medical Technologist - $42-46 per hour

    Local Contract Medical Technologist - $42-46 per hour

    Host HealthcareSouth Norfolk, VA, US
    serp_jobs.job_card.full_time
    Host Healthcare is seeking a local contract Medical Technologist for a local contract job in Norfolk, Virginia.Job Description & Requirements Specialty : Medical Technologist Discipline : Allied Heal...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Travel Medical Technologist - $2,044 per week

    Travel Medical Technologist - $2,044 per week

    Host HealthcareSouth Norfolk, VA, US
    serp_jobs.job_card.full_time
    Host Healthcare is seeking a travel Medical Technologist for a travel job in Norfolk, Virginia.Job Description & Requirements Specialty : Medical Technologist Discipline : Allied Health Professional ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Associate Medical Officer

    Associate Medical Officer

    ChenMedVirginia Beach, VA, United States
    serp_jobs.job_card.full_time
    We’re changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Medical Manager

    Medical Manager

    ChenMedVirginia Beach, VA, United States
    serp_jobs.job_card.full_time
    We’re changing lives every day.For both our patients and our team members.Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Physician / Medical Director / Virginia / Locum or Permanent / Part-Time Backup Medical Director Job

    Physician / Medical Director / Virginia / Locum or Permanent / Part-Time Backup Medical Director Job

    Samuel Contract Staffing LLCNorfolk, VA, US
    serp_jobs.job_card.part_time
    I work with a Plasma Donation Center in Norfolk, VA.We have an open position for a back-up Medical Director (MD or DO) to join us 4 hours a month. Must be within 40 miles of the clinic.Competitive s...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Medical Director – Breast Imaging

    Senior Medical Director – Breast Imaging

    Southern Ohio Medical CenterPortsmouth, US
    serp_jobs.job_card.full_time
    Southern Ohio Medical Center (SOMC) is recruiting a fellowship-trained Breast Imaging Radiologist to serve as Senior Medical Director of our Breast Center. This leadership role offers the ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Center Medical Director

    Center Medical Director

    CSLNorfolk, VA, US
    serp_jobs.job_card.full_time
    Do Work That Matters At CSL Plasma!.Plasma Operations provides operational initiatives with the goal of aligning center processes, improving operational efficiencies to ensure center development an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Medical Director, Pediatric Sleep Studies, Department of Pediatrics

    Medical Director, Pediatric Sleep Studies, Department of Pediatrics

    InsideHigherEdAll Cities, Virginia, United States
    serp_jobs.job_card.full_time
    The Department of Pediatrics Division of Respiratory and Sleep Medicine, Allergy, and Immunology at the University of Virginia School of Medicine and the UVA Children's Hospital, seek candidates fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Product Manager, Medical Device / Global Spine & Orthopedics

    Product Manager, Medical Device / Global Spine & Orthopedics

    LifeNet HealthVirginia Beach, VA, US
    serp_jobs.job_card.full_time
    Marketing Position At LifeNet Health.At LifeNet Health, you are the advantage.Every day, you help us to save lives, restore health, and bring hope to patients and families around the world.At LifeN...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Medical Director of Radiation Oncology in Ohio - $715k base salary + $100k Sign on Bonus + bonuses

    Senior Medical Director of Radiation Oncology in Ohio - $715k base salary + $100k Sign on Bonus + bonuses

    Southern Ohio Medical CenterPortsmouth, US
    serp_jobs.job_card.full_time
    Seeking a Board Certified / Board Eligible Radiation Oncologist to join our joint commission accredited cancer center.Leadership experience preferred. Base salary of $715,578 • for initial two year co...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Open Rank Professor of Pathology

    Open Rank Professor of Pathology

    InsideHigherEdAll Cities, Virginia, United States
    serp_jobs.job_card.full_time
    The Department of Pathology and Laboratory Medicine at the University of Virginia invites applications for a full time Anatomic Pathology or Anatomic Pathology and Clinical Pathology certified Path...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    NEW Director of Laboratory Services / Laboratory Director Opening

    NEW Director of Laboratory Services / Laboratory Director Opening

    K.A. RecruitingVirginia Beach, VA, US
    serp_jobs.job_card.full_time
    A leading healthcare provider is seeking an experienced and visionary Director of Laboratory Services to oversee consolidated hospital laboratory operations across a regional network.This is a key ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Copy of Medical Assistant / Scribe

    Copy of Medical Assistant / Scribe

    Hampton Roads Otolaryngology AssocHampton, VA, US
    serp_jobs.job_card.full_time
    Primary Function : Medical Scribe duties include performing all clerical and information technology functions for a physician in a clinic setting. This includes primary responsibility of the operatio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Laboratory Systems Director - Permanent Hire

    Laboratory Systems Director - Permanent Hire

    K.A. RecruitingChesapeake, VA, US
    serp_jobs.job_card.permanent
    Assumes full responsibility and accountability for the effective management and success of integrated hospital laboratory operations, including shared services such as pathology, transfusion medici...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Proposal Writer (Virginia Beach, VA) Job at S B BALLARD CONSTRUCTION CO in Virgi

    Proposal Writer (Virginia Beach, VA) Job at S B BALLARD CONSTRUCTION CO in Virgi

    MediabistroVirginia Beach, VA, United States
    serp_jobs.job_card.full_time
    Responsible for the entire proposal process from research, writing, design, and edit through final submission with ensuring the delivery of a quality product. Coordinate and support the full life cy...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    NEXWDC Doctrine Writer

    NEXWDC Doctrine Writer

    PrevailanceVirginia Beach, VA, US
    serp_jobs.job_card.full_time
    This position is currently filled, however we are accepting applications for Ready Replacement Pool consideration.A subject matter expert (SME), working with a collaborative team, to analyze and ev...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Contract Officer and Contract Technical Writer

    Contract Officer and Contract Technical Writer

    Clearance JobsNorfolk, VA, US
    serp_jobs.job_card.full_time
    Contract Specialist / Technical Writer / Editor.Systems Planning and Analysis, Inc.SPA) delivers high-impact, technical solutions to complex national security issues. With over 50 years of business expe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Technical Writer III

    Technical Writer III

    Synectic Solutions IncNorfolk, VA, US
    serp_jobs.job_card.full_time
    Support Manager in technical writing and development.Lead weekly status report meeting documenting accomplishments, planned actions, and roadblocks. Writes, validates and update training material, e...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30