Talent.com
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Job at
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Job atMediabistro • New York City, NY, United States
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Job at

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Job at

Mediabistro • New York City, NY, United States
job_description.job_card.variable_hours_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 SponsorSyneos 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 EVERYWHEREWhy 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 - $210,900.00The 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 HealthOver 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.Additional InformationTasks, 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 • New York City, NY, United States

    Job_description.internal_linking.related_jobs
    Associate Director Principal Medical Writer

    Associate Director Principal Medical Writer

    Sanofi • MORRISTOWN, NJ, US
    serp_jobs.job_card.full_time
    Job Title : Associate Director-Principal Medical Writer.Proximity to Cambridge / Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings. Are you ready to shape the futu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Director, Medical Writer Job at Cellectis in New York

    Director, Medical Writer Job at Cellectis in New York

    Mediabistro • New York, NY, United States
    serp_jobs.job_card.full_time
    The Director, Medical Writing will be an integral position working with the Clinical Development function to facilitate the translation of complex scientific and medical information into clear and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Joulé is hiring : Senior Medical Writer in Village of Tarrytown

    Joulé is hiring : Senior Medical Writer in Village of Tarrytown

    Mediabistro • Village of Tarrytown, NY, United States
    serp_jobs.job_card.temporary
    Be among the first 25 applicants.The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narrati...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Mediabistro • New York, NY, United States
    serp_jobs.job_card.full_time
    Senior Principal Medical Writer - Regulatory - Oncology - Single SponsorSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.new
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • New York, NY, United States
    serp_jobs.job_card.full_time
    Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Medical Writer

    Senior Medical Writer

    VirtualVocations • Paterson, New Jersey, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Medical Writer to lead the development of regulatory and clinical documents.Key Responsibilities Lead the preparation and review of clinical study reports, proto...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Medical Writer

    Principal Medical Writer

    VirtualVocations • New York, New York, United States
    serp_jobs.job_card.full_time
    A company is looking for a Principal Medical Writer - Publications (Bench / Freelance).Key Responsibilities Leads the planning, development, and execution of scientific publications across therapeu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Medical Writer (Remote)

    Senior Medical Writer (Remote)

    MMS • Jersey City, NJ, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory sub...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Medical Writer - Medical Communications - East Coast

    Medical Writer - Medical Communications - East Coast

    Prime • New York, NY, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Accelerating Life-Changing Solutions to Global Healthcare Challenges .It speaks to the significant challenges that exist within global healthcare, and how we, as one team, can help to deliver ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Senior Medical Writer Job at Evolution Health Group, LLC in Pearl River

    Senior Medical Writer Job at Evolution Health Group, LLC in Pearl River

    Mediabistro • Pearl River, NY, United States
    serp_jobs.job_card.full_time
    Evolution Medical Communications.P2P engagement strategy from pre-launch to LOE.We have been evolving (no pun intended) and growing since 2005. We take pride in our strategic partnerships with our c...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Cella is hiring : Principal Medical Writer - Publications (Bench / Freelance) in Ra

    Cella is hiring : Principal Medical Writer - Publications (Bench / Freelance) in Ra

    Mediabistro • Rahway, NJ, United States
    serp_jobs.job_card.full_time
    Location : Fully remoteType : Ongoing contractHours : Freelance / fluctuating hours (there may be weeks with 0 hours)Compensation Range : $88 - 93 per hour •We cannot consider candidates working full time...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day
    Principal Medical Writer - Publications (Bench / Freelance) Job at Cella in Rahway

    Principal Medical Writer - Publications (Bench / Freelance) Job at Cella in Rahway

    Mediabistro • Rahway, NJ, United States
    serp_jobs.job_card.full_time
    Location : Fully remoteType : Ongoing contractHours : Freelance / fluctuating hours (there may be weeks with 0 hours)Compensation Range : $88 - 93 per hour •We cannot consider candidates working full time...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day
    Associate Medical Writer - Medical Communications - East Coast

    Associate Medical Writer - Medical Communications - East Coast

    Prime • New York, NY, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Accelerating Life-Changing Solutions to Global Healthcare Challenges .It speaks to the significant challenges that exist within global healthcare, and how we, as one team, can help to deliver ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Principal Medical Publications Writer

    Principal Medical Publications Writer

    VirtualVocations • Paterson, New Jersey, United States
    serp_jobs.job_card.full_time
    A company is looking for a Principal Medical Publications Writer to lead the preparation and development of high-quality medical publications and documents. Key Responsibilities Serve as a subject...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Principal Medical Writer - Publications (Bench / Freelance)

    Principal Medical Writer - Publications (Bench / Freelance)

    Mediabistro • Rahway, NJ, United States
    serp_jobs.job_card.full_time
    Location : Fully remoteType : Ongoing contractHours : Freelance / fluctuating hours (there may be weeks with 0 hours)Compensation Range : $88 - 93 per hour •We cannot consider candidates working full time...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • New York, NY, United States
    serp_jobs.job_card.full_time
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLC • New York, NY, 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_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director-Principal Medical Writer

    Associate Director-Principal Medical Writer

    Sanofi • MORRISTOWN, NJ, US
    serp_jobs.job_card.full_time
    Associate Director-Principal Medical Writer.Proximity to Cambridge / Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings. Are you ready to shape the future of medic...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new