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

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health / inVentiv Health Commercial LLC • Oklahoma City, OK, United States
21 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 • Oklahoma City, OK, United States

    Related jobs
    Manager, Medical Core Content - Rare Disease

    Manager, Medical Core Content - Rare Disease

    Otsuka Pharmaceutical • Oklahoma City, OK, US
    Full-time
    The Manager, Medical Core Content is a team-level operational role responsible for the development, maintenance, and day-to-day quality assurance of all core scientific and medical content for the ...Show more
    Last updated: 2 days ago • Promoted
    Travel Nurse RN - ICU - Intensive Care Unit

    Travel Nurse RN - ICU - Intensive Care Unit

    Rang Healthcare • Chickasha, OK, US
    Permanent
    Rang Healthcare is seeking a travel nurse RN ICU - Intensive Care Unit for a travel nursing job in Chickasha, Oklahoma.Job Description & Requirements. We are an equal opportunity employer.It is ...Show more
    Last updated: 3 hours ago • Promoted • New!
    Travel Nurse RN - ICU - Intensive Care Unit

    Travel Nurse RN - ICU - Intensive Care Unit

    Malone Healthcare - Nursing • Chickasha, OK, US
    Full-time
    Malone Healthcare - Nursing is seeking a travel nurse RN ICU - Intensive Care Unit for a travel nursing job in Chickasha, Oklahoma. Job Description & Requirements.About Malone Healthcare - Nursi...Show more
    Last updated: 2 days ago • Promoted
    Travel Certified Surgical Technologist

    Travel Certified Surgical Technologist

    First Connect Health • Norman, OK, US
    Full-time
    First Connect Health is seeking a travel Certified Surgical Technologist for a travel job in Norman, Oklahoma.Job Description & Requirements. Certified Surgical Technologist.First Connect Health...Show more
    Last updated: 3 days ago • Promoted
    Freelance Content Writer

    Freelance Content Writer

    Outlier • Norman, OK, United States
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 7 days ago • Promoted
    Sr Medical Writer (Publications)

    Sr Medical Writer (Publications)

    Syneos Health / inVentiv Health Commercial LLC • Oklahoma City, OK, United States
    Full-time
    Sr Medical Writer (Publications).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affa...Show more
    Last updated: 16 hours ago • Promoted • New!
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLC • Oklahoma City, OK, United States
    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 ...Show more
    Last updated: 21 days ago • Promoted
    GI Endoscopy Technologist Lead - Outpatient Surgery Center

    GI Endoscopy Technologist Lead - Outpatient Surgery Center

    Mercy • Edmond, OK, US
    Full-time
    Mercy Outpatient Surgery Center - Edmond I-35.Maintains professional accountability and technical support for provision of patient care for the endoscopy patients experience.As directed, may be pre...Show more
    Last updated: 4 days ago • Promoted
    Freelance Writer

    Freelance Writer

    Outlier • Oklahoma City, OK, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 10 days ago • Promoted
    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based

    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based

    Syneos Health / inVentiv Health Commercial LLC • Oklahoma City, OK, United States
    Full-time
    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to acceler...Show more
    Last updated: 6 days ago • Promoted
    Travel Nurse RN - Endoscopy

    Travel Nurse RN - Endoscopy

    Talent4Health • Edmond, OK, US
    Full-time
    Talent4Health is seeking a travel nurse RN Endoscopy for a travel nursing job in Edmond, Oklahoma.Job Description & Requirements. Required Skills & Experience : .Knowledge of professional nurs...Show more
    Last updated: 30+ days ago • Promoted
    Principal Medical Writer - Submission Docs (2.5 / 2.7.2 / 2.7.3 / 2.7.4) - Oncology - Remote Based

    Principal Medical Writer - Submission Docs (2.5 / 2.7.2 / 2.7.3 / 2.7.4) - Oncology - Remote Based

    Syneos Health / inVentiv Health Commercial LLC • Oklahoma City, OK, United States
    Remote
    Full-time
    Principal Medical Writer - Submission Docs (2.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical,...Show more
    Last updated: 16 hours ago • Promoted • New!
    Travel Nurse RN - Endoscopy

    Travel Nurse RN - Endoscopy

    Travel Nurses, Inc. • Edmond, OK, US
    Full-time
    RN Endoscopy for a travel nursing job in Edmond, Oklahoma.Job Description & Requirements.Pay package is based on 8 hour shifts and 40 hours per week (subject to confirmation) with tax-free stip...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Endoscopy

    Travel Nurse RN - Endoscopy

    ProKatchers • Edmond, OK, US
    Full-time
    ProKatchers is seeking a travel nurse RN Endoscopy for a travel nursing job in Edmond, Oklahoma.Job Description & Requirements. Graduate of an accredited nursing program.License, Certification, ...Show more
    Last updated: 3 days ago • Promoted
    Remote Freelance Content Writer

    Remote Freelance Content Writer

    Outlier • Norman, OK, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 7 days ago • Promoted
    Telemedicine Physician

    Telemedicine Physician

    QuickMD • Chickasha, OK, US
    Full-time
    QuickMD is a leading telemedicine provider, delivering high-quality virtual care across 44 states.Since our founding in 2019, we have helped more than 100,000 patients access essential medical trea...Show more
    Last updated: 30+ days ago • Promoted
    Flexible Content Writer

    Flexible Content Writer

    Outlier • Norman, OK, United States
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 7 days ago • Promoted
    Remote Part-Time Writer

    Remote Part-Time Writer

    Outlier • Norman, OK, United States
    Remote
    Part-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 7 days ago • Promoted