Talent.com
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 LLCDetroit, MI, United States
4 days ago
Job type
  • Full-time
Job description

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 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

  • Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
  • Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed.
  • Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and / or direct supervisor (as appropriate) if deliverables are at risk.
  • Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles.
  • Serves as project lead for deliverables of assigned complex and / or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable.
  • Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process.
  • Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices.
  • Performs quality review of assigned documents to ensure accuracy.
  • Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
  • Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
  • May compile medical writing deliverables.
  • 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 :

    $62,000.00 - $108,600.00

    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

    Copy Editor • Detroit, MI, United States

    Related jobs
    • Promoted
    Local Contract MRI Technologist

    Local Contract MRI Technologist

    AG Globe ServicesPontiac, MI, US
    Full-time
    AG Globe Services is seeking a local contract MRI Technologist for a local contract job in Pontiac, Michigan.Job Description & Requirements. Acute Care Hospital | Start Date : 12 / 1 / 2025.Why Clini...Show moreLast updated: 23 days ago
    • Promoted
    CRNA - Anesthesiology job available in Trenton, Michigan

    CRNA - Anesthesiology job available in Trenton, Michigan

    NorthStar AnesthesiaTrenton, MI, US
    Full-time
    Get the Recognition Youve Earned.Build Your Future with NorthStar.Join NorthStar Anesthesia as we continue our exciting nationwide expansion! Were seeking passionate CRNAs to help deliver excellenc...Show moreLast updated: 30+ days ago
    • Promoted
    All Ages Outpatient Licensed Therapist (LCSW, LPC, LMFT, LMSW).

    All Ages Outpatient Licensed Therapist (LCSW, LPC, LMFT, LMSW).

    LifeStance HealthAlgonac, MI, US
    Full-time
    We are actively looking to hire talented Therapists in the area, who are passionate about patient care and committed to clinical excellence. Wanting to deliver high quality behavioral healthcare.Int...Show moreLast updated: 30+ days ago
    • Promoted
    Child and Adolescent Outpatient Licensed Therapist (LCSW, LMFT, LPC, LMSW).

    Child and Adolescent Outpatient Licensed Therapist (LCSW, LMFT, LPC, LMSW).

    LifeStance HealthAlgonac, MI, US
    Full-time
    We are actively looking to hire talented Therapists in the area, who are passionate about patient care and committed to clinical excellence. Wanting to deliver high quality behavioral healthcare.Int...Show moreLast updated: 30+ days ago
    • Promoted
    Technical Writer Senior (On-site)

    Technical Writer Senior (On-site)

    HEPCO, Inc.Sterling Heights, Michigan, US
    Full-time
    The Senior Technical Writer is responsible for producing and revising complex documentation that supports product operation, repair, maintenance, and marketing. Creating and updating detailed techni...Show moreLast updated: 22 days ago
    • Promoted
    Senior Regulatory Writer

    Senior Regulatory Writer

    Complete Regulatory | An IPG Health Companywindsor, on, ca
    Full-time
    Complete Regulatory, part of IPG Health Medical Communications, is home to over 500 experts across some of the world’s most awarded med comms agencies. We blend science, creativity, and technology t...Show moreLast updated: 30+ days ago
    • Promoted
    Local Contract CT Technologist

    Local Contract CT Technologist

    Host HealthcarePontiac, MI, US
    Full-time
    Host Healthcare is seeking a local contract CT Technologist for a local contract job in Pontiac, Michigan.Job Description & Requirements. Pay package is based on 11 hour shifts and 40 hours per ...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Nuclear Medicine Technologist

    Travel Nuclear Medicine Technologist

    HonorVet TechnologiesMonroe, MI, US
    Full-time
    HonorVet Technologies is seeking a travel Nuclear Medicine Technologist for a travel job in Monroe, Michigan.Job Description & Requirements. Position : Nuclear Medicine Technologist.Shift : Days, ...Show moreLast updated: 22 days ago
    • Promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLCDetroit, MI, United States
    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...Show moreLast updated: 19 days ago
    • Promoted
    Local Contract Nurse RN - ED - Emergency Department

    Local Contract Nurse RN - ED - Emergency Department

    Trusted Resource Associates (TRA)Commerce, MI, US
    Full-time
    Trusted Resource Associates (TRA) is seeking a local contract nurse RN ED - Emergency Department for a local contract nursing job in Commerce Charter Twp, Michigan. Job Description & Requirement...Show moreLast updated: 30+ days ago
    • Promoted
    Local Contract CT Technologist

    Local Contract CT Technologist

    AG Globe ServicesPontiac, MI, US
    Full-time
    AG Globe Services is seeking a local contract CT Technologist for a local contract job in Pontiac, Michigan.Job Description & Requirements. Acute Care Hospital | Start Date : 11 / 24 / 2025.Why Clini...Show moreLast updated: 30+ 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, part of IPG Health Medical Communications, is home to over 500 experts across some of the world’s most awarded med comms agencies. We blend science, creativity, and technology t...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Senior Reg Publishing Specialist

    Senior Reg Publishing Specialist

    Thermo FisherDetroit, MI, US
    Full-time
    Senior Reg Publishing Specialist.This is an outstanding opportunity to join Thermo Fisher Scientific as a Senior Reg Publishing Specialist. You will play a pivotal role in ensuring flawless regulato...Show moreLast updated: 21 hours ago
    • Promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLCDetroit, MI, 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 moreLast updated: 10 days ago
    • Promoted
    • New!
    Travel Nuclear Medicine Tech - $2,574 to $2,877 per week in Monroe, MI

    Travel Nuclear Medicine Tech - $2,574 to $2,877 per week in Monroe, MI

    AlliedTravelCareersMonroe, MI, US
    Full-time
    AlliedTravelCareers is working with Prime Time Healthcare to find a qualified Nuclear Medicine Tech in Monroe, Michigan, 48161!. Now Hiring : Allied Healthcare Nuclear Medicine - Monroe, MI.Contact u...Show moreLast updated: 14 hours ago
    Senior Medical Writer (Remote)

    Senior Medical Writer (Remote)

    MMSCanton, MI, US
    Remote
    Full-time
    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...Show moreLast updated: 30+ days ago
    • Promoted
    Local Contract Nuclear Medicine Technologist

    Local Contract Nuclear Medicine Technologist

    Medical Solutions AlliedWest Bloomfield, MI, US
    Full-time
    Medical Solutions Allied is seeking a local contract Nuclear Medicine Technologist for a local contract job in West Bloomfield, Michigan. Job Description & Requirements.We’re seeking talen...Show moreLast updated: 1 day ago
    Senior Medical Writer (Project-Based) - Remote

    Senior Medical Writer (Project-Based) - Remote

    MMSCanton, MI, US
    Remote
    Full-time
    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...Show moreLast updated: 30+ days ago