Talent.com
Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

Syneos Health / inVentiv Health Commercial LLCDetroit, MI, United States
3 days ago
Job type
  • Full-time
Job description

Principal / Senior Medical Writer - Regulatory - Oncology - North America / United Kingdom and Ireland (homebased)

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

Job responsibilities

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Acts as lead for assigned writing projects.
  • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
  • Develops or supports a variety of documents that include, but not limited to :
  • Clinical study protocols and clinical protocol amendments;

  • Clinical study reports;
  • Patient narratives;
  • Clinical development plans;
  • IND submissions and annual reports;
  • Integrated summary reports;
  • NDA and (e)CTD submissions;
  • Investigator brochures, as well as;
  • Clinical journal manuscripts, clinical journal abstracts, and client presentations.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Reviews statistical analysis plans and table / figure / listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Serves as peer reviewer on internal review team providing review comments on draft and final documents.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and / or client approved templates when completing medical writing projects, on-time and on-budget.
  • Performs on-line clinical literature searches, as applicable.
  • Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
  • Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
  • Completes required administrated tasks within the specified timeframes.
  • Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
  • Qualifications
  • What we're looking for

    Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and / or medical knowledge and expertise.

  • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
  • Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
  • 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

    Medical Writer • Detroit, MI, United States

    Related jobs
    • Promoted
    Senior Regulatory Writer - windsor

    Senior Regulatory Writer - windsor

    Complete Regulatory | An IPG Health Companywindsor, on, ca
    Full-time
    Complete Regulatory is part of IPG Health Medical Communications, who is home to the world’s most celebrated and awarded Med Comms agencies. We are 800 experts obsessed with combining science, creat...Show moreLast updated: 5 days ago
    • Promoted
    Medical Assistant - Float

    Medical Assistant - Float

    VillageMDWalled Lake, MI, US
    Full-time
    Float Pool Clinic Locations : Westland, Walled Lake, Livonia, Northville, Novi, South Lyon and Farmington.This position is floating and a schedule is given out weekly on where you will be working ea...Show moreLast updated: 9 days ago
    The Ash Group is hiring : Senior Technical Writer in Sterling Heights

    The Ash Group is hiring : Senior Technical Writer in Sterling Heights

    MediabistroSterling Heights, MI, United States
    Temporary
    Senior Technical Recruiter / Account Manager at The Ash Group.Sterling Heights, MI (fully onsite).Creates and revises complex technical documentation to support the marketing, operation, repair, and ...Show moreLast updated: 6 days ago
    Technical Writer Job at The Judge Group in Sterling Heights

    Technical Writer Job at The Judge Group in Sterling Heights

    MediabistroSterling Heights, MI, United States
    Full-time
    Be among the first 25 applicants.This range is provided by The Judge Group.Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Title : Senior Technic...Show moreLast updated: 8 days ago
    • Promoted
    Senior Regulatory Writer

    Senior Regulatory Writer

    Complete Regulatory | An IPG Health Companywindsor, on, ca
    Full-time
    Complete Regulatory is part of IPG Health Medical Communications, who is home to the world’s most celebrated and awarded Med Comms agencies. We are 800 experts obsessed with combining science, creat...Show moreLast updated: 5 days ago
    Brightview Care is hiring : Grant Writer in Southfield

    Brightview Care is hiring : Grant Writer in Southfield

    MediabistroSouthfield, MI, United States
    Full-time
    Brightview Care you will lead the identification, application, and coordination of grants, ensuring compliance with all relevant standards, regulations, and guidelines. Research and identify grant o...Show moreLast updated: 14 days ago
    • Promoted
    Rheumatologist- Medical Director-Pacific Northwest

    Rheumatologist- Medical Director-Pacific Northwest

    AMN HealthcareCLARKSTON, US
    Full-time
    Job Description & Requirements.Rheumatologist- Medical Director-Pacific Northwest.StartDate : ASAP Pay Rate : $285000.An award-winning hospital that has been providing exceptional patient care for mo...Show moreLast updated: 26 days ago
    • Promoted
    Senior Regulatory Writer - Complete Regulatory | An IPG Health Company

    Senior Regulatory Writer - Complete Regulatory | An IPG Health Company

    Complete Regulatory | An IPG Health Companywindsor, on, ca
    Full-time
    Complete Regulatory is part of IPG Health Medical Communications, who is home to the world’s most celebrated and awarded Med Comms agencies. We are 800 experts obsessed with combining science, creat...Show moreLast updated: 5 days ago
    • Promoted
    Grant Writer

    Grant Writer

    Brightview CareSouthfield, MI, US
    Full-time
    Brightview Care you will lead the identification, application, and coordination of grants, ensuring compliance with all relevant standards, regulations, and guidelines. Research and identify grant o...Show moreLast updated: 2 days ago
    • Promoted
    Medical Assistant- Surgical Oncology-Contingent

    Medical Assistant- Surgical Oncology-Contingent

    Henry Ford Health SystemGrosse Pointe, MI, United States
    Full-time
    Location : Grosse Pointe Woods, MI.Assist with the examination and treatment of patients under the direction of a physician. Assist with treatments ordered by physician as supervised by physician or ...Show moreLast updated: 5 days ago
    TAD PGS is hiring : Senior Technical Writer in Sterling Heights

    TAD PGS is hiring : Senior Technical Writer in Sterling Heights

    MediabistroSterling Heights, MI, United States
    Full-time
    We have an outstanding Contract position for a.Creates and revises complex technical documentation to support the marketing, operation, repair, and maintenance of company products.Ensures documents...Show moreLast updated: 2 days ago
    MMS Holdings Inc is hiring : Nonclinical Writer in Canton Charter Township

    MMS Holdings Inc is hiring : Nonclinical Writer in Canton Charter Township

    MediabistroCanton Charter Township, MI, United States
    Full-time
    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 an award-winning, data-focused clinical research organizat...Show moreLast updated: 2 days ago
    • Promoted
    Intermediate Technical Writer - windsor

    Intermediate Technical Writer - windsor

    Calian Groupwindsor, on, ca
    Full-time +1
    Calian is seeking 2 Intermediate Technical Writers to assist our client with the facilitation of their project.Develop content : Research and write concept, design, and discussion papers on future C...Show moreLast updated: 1 day ago
    • Promoted
    Novi Vehicles Service Writer

    Novi Vehicles Service Writer

    MARTIN TechnologiesNovi, MI, US
    Full-time
    MARTIN Technologies (MARTIN) is a full-service, global engineering and manufacturing company supporting OEM and Tier customers in the automotive industries. We are leaders in the mobility industry a...Show moreLast updated: 30+ days ago
    • Promoted
    Intermediate Technical Writer - Calian Group

    Intermediate Technical Writer - Calian Group

    Calian Groupwindsor, on, ca
    Full-time +1
    Calian is seeking 2 Intermediate Technical Writers to assist our client with the facilitation of their project.Develop content : Research and write concept, design, and discussion papers on future C...Show moreLast updated: 1 day ago
    • Promoted
    Medical Assistant

    Medical Assistant

    ChenMedEastpointe, MI, US
    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...Show moreLast updated: 30+ days ago
    Grant Writer

    Grant Writer

    MediabistroSouthfield, MI, United States
    Full-time
    Brightview Care you will lead the identification, application, and coordination of grants, ensuring compliance with all relevant standards, regulations, and guidelines. Research and identify grant o...Show moreLast updated: 1 day ago
    • Promoted
    Senior Medical Assistant / Assistant Manager

    Senior Medical Assistant / Assistant Manager

    Oakwayne Medical centerWestland, MI, US
    Full-time
    Oakwayne Medical Center is a small, patient-centered medical practice dedicated to providing high-quality care in a compassionate and efficient environment. We value teamwork, professionalism, and a...Show moreLast updated: 30+ days ago
    • Promoted
    Medical Assistant - Float

    Medical Assistant - Float

    Michigan Orthopaedic Surgeons PLLCUtica, MI, US
    Full-time
    As the largest and most comprehensive orthopaedic team in the state, we’ve combined the medical expertise of the state’s finest orthopaedic and musculoskeletal surgeons, specialists, an...Show moreLast updated: 24 days ago
    • Promoted
    Technical Writer

    Technical Writer

    TradeJobsWorkForce48306 Rochester Hills, MI, US
    Full-time
    Research, write, edit and proofread complex technical data.Create, maintain and update manuals, procedures, specifications and other documents. Create, maintain and update installation instructions,...Show moreLast updated: 30+ days ago