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

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health / inVentiv Health Commercial LLCIndianapolis, IN, 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 • Indianapolis, IN, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Technical Report Writer I

    Technical Report Writer I

    August Mack Environmental, Inc.Indianapolis, IN, US
    serp_jobs.job_card.full_time
    Responsible for reporting scientific and technical information in a manner that can be understood by an average reader.Responsible for research and preparing technical reports to support due dilige...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Associate Director - Oncology - Clinical Laboratory Sciences

    Associate Director - Oncology - Clinical Laboratory Sciences

    Eli LillyIndianapolis, IN, US
    serp_jobs.job_card.full_time
    Associate Director - Oncology - Clinical Laboratory Sciences.At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Director

    Medical Director

    Theoria MedicalPlainfield, IN, US
    serp_jobs.job_card.full_time
    Leading the charge in healthcare innovation, Theoria Medical offers a unique blend of medical excellence and technological advancement, primarily serving the post-acute and primary care sectors.Our...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    HSE Permit Writer

    HSE Permit Writer

    MediabistroLebanon, IN, United States
    serp_jobs.job_card.full_time
    Health Safety and Environment Permit Writer.At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis,...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Senior Advisor / Director Global Regulatory Affairs CMC – Commercial Product / Post Approval Scientist for Solid Oral Products

    Senior Advisor / Director Global Regulatory Affairs CMC – Commercial Product / Post Approval Scientist for Solid Oral Products

    Eli LillyIndianapolis, IN, US
    serp_jobs.job_card.full_time
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    Clinical Architecture is hiring : Technical Writer in Indianapolis

    Clinical Architecture is hiring : Technical Writer in Indianapolis

    MediabistroIndianapolis, IN, United States
    serp_jobs.job_card.full_time
    Clinical Architecture is at the forefront of healthcare IT innovation.Our team is an ambitious group of diverse leaders who balance creativity and expertise to solve tough problems that make a diff...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Medical Asst Certified Oncology

    Medical Asst Certified Oncology

    Riverview HealthNoblesville, IN, US
    serp_jobs.job_card.part_time
    Medical Asst Certified Oncology.Requisition Number : MEDIC002956.Prepare patients for physician / provider examination and administers injections and immunizations. Performs laboratory testing, EKG's a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    RocheIndianapolis, IN, US
    serp_jobs.job_card.full_time
    At Roche you can show up as yourself, embraced for the unique qualities you bring.Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director - Global Scientific Communications (GSC) Publication Strategy & Execution

    Associate Director - Global Scientific Communications (GSC) Publication Strategy & Execution

    Eli LillyIndianapolis, IN, US
    serp_jobs.job_card.full_time
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Medical Assistant - MOHS

    Medical Assistant - MOHS

    My Derm RecruiterWestfield, IN, US
    serp_jobs.job_card.full_time
    Mohs Surgery Medical Assistant.The Mohs Surgery Medical Assistant plays a key role in supporting the Mohs Surgeon during procedures, ensuring a smooth surgical workflow, maintaining a sterile envir...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Assistant Certified - Float Pool

    Medical Assistant Certified - Float Pool

    Riverview HealthNoblesville, IN, United States
    serp_jobs.job_card.full_time
    The Certified Medical Assistant assists in preparation for patient care, provides care coordination, clinical documentation, and other clinical support functions in a physician practice office sett...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    Sr. Director - Global Regulatory Lead - Neuroscience / Immunology

    Sr. Director - Global Regulatory Lead - Neuroscience / Immunology

    Eli LillyIndianapolis, IN, US
    serp_jobs.job_card.full_time
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Clinical Affairs, Senior (Study Operations) - Transplant Diagnostic

    Clinical Affairs, Senior (Study Operations) - Transplant Diagnostic

    Thermo FisherFishers, IN, US
    serp_jobs.job_card.full_time
    Clinical Affairs, Senior Study Operations.In this role, you will have the unique opportunity to lead clinical study operations to include clinical trial budgeting and study management activities.Y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    Syneos Health, Inc. is hiring : Medical Writer I in Indianapolis

    Syneos Health, Inc. is hiring : Medical Writer I in Indianapolis

    MediabistroIndianapolis, IN, United States
    serp_jobs.job_card.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 ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Dedicated Writer

    Dedicated Writer

    TradeJobsWorkForce46104 Arlington, IN, US
    serp_jobs.job_card.full_time
    Dedicated Writer Job Duties : Computer with internet access Office 365 or Microsoft Office Suite Mo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Sr. Director - Scientific Content - Cardiometabolic Health Global Medical Affairs

    Sr. Director - Scientific Content - Cardiometabolic Health Global Medical Affairs

    Eli LillyIndianapolis, IN, US
    serp_jobs.job_card.full_time
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    Otsuka America Pharmaceutical Inc. is hiring : Senior Manager Medical Writing in

    Otsuka America Pharmaceutical Inc. is hiring : Senior Manager Medical Writing in

    MediabistroIndianapolis, IN, United States
    serp_jobs.job_card.full_time
    The Senior Manager, Medical Writing (MW) will be responsible for leading and advising on medical writing processes and activities for individual asset teams to which they are assigned.The Senior Ma...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    Nonclinical Writer

    Nonclinical Writer

    MMSIndianapolis, IN, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director-Transfusion Medicine and Apheresis Within a Top Ranked Health System

    Director-Transfusion Medicine and Apheresis Within a Top Ranked Health System

    Indiana University HealthIndianapolis, IN, US
    serp_jobs.job_card.permanent
    The Department of Pathology and Laboratory Medicine at the Indiana University School of Medicine (IUSM) in conjunction with IU Health Medical Group (IUHMG), are seeking a dynamic, forward-thinking,...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Medical Assistant - MOHS

    Medical Assistant - MOHS

    Forefront DermatologyWestfield, IN, United States
    serp_jobs.job_card.full_time
    The Mohs Surgery Medical Assistant plays a key role in supporting the Mohs Surgeon during procedures, ensuring a smooth surgical workflow, maintaining a sterile environment, and providing post-oper...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days