Talent.com
Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based
Sr Medical Writer - Medical Device + Regulatory Documents - Remote BasedSyneos Health/ inVentiv Health Commercial LLC • Denver, CO, United States
Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

Syneos Health / inVentiv Health Commercial LLC • Denver, CO, United States
12 days ago
Job type
  • Full-time
  • Remote
Job description

Sr Medical Writer - Medical Device + Regulatory Documents - 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

  • Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
  • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
  • 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, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
  • Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed.
  • Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
  • Reviews statistical analysis plans and table / figure / listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
  • Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
  • Performs online clinical literature searches and complies with copyright requirements.
  • Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
  • Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
  • Completes required administrative tasks within the specified timeframes.
  • Performs other work-related duties as assigned.
  • Minimal travel may be required (less than 25%).
  • 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 :

    $80,600.00 - $145,000.00

    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

    Medical Writer • Denver, CO, United States

    Related jobs
    Travel Medical Technologist

    Travel Medical Technologist

    MedPro Healthcare Allied Staffing • Denver, CO, US
    Full-time
    MedPro Healthcare Allied Staffing is seeking a travel Medical Technologist for a travel job in Denver, Colorado.Job Description & Requirements. Joint Commission-certified staffing agency, is see...Show more
    Last updated: 30+ days ago • Promoted
    Medical Assistant

    Medical Assistant

    U.S. Navy • Westminster, CO, US
    Full-time +1
    To be eligible to enlist in the U.Navy, candidates must be between the ages of 18-34.The Navy relies on exceptional medical personnel to keep our servicemen and women healthy.As a Hospital Corpsman...Show more
    Last updated: 28 days ago • Promoted
    Travel Physical Therapist (PT) - $1,419 to $1,710 per week in Castle Rock, CO

    Travel Physical Therapist (PT) - $1,419 to $1,710 per week in Castle Rock, CO

    Fusion Medical Staffing • Castle Rock, CO, US
    Full-time
    Travel Physical Therapist (PT).Facility in Castle Rock, Colorado.Fusion Medical Staffing is seeking a skilled Physical Therapist for a 13-week travel assignment in Castle Rock, Colorado.As a member...Show more
    Last updated: 13 days ago • Promoted
    Travel Medical Technologist

    Travel Medical Technologist

    Host Healthcare • Denver, CO, US
    Full-time
    Host Healthcare is seeking a travel Medical Technologist for a travel job in Denver, Colorado.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 hours per week (subject...Show more
    Last updated: 30+ days ago • Promoted
    Travel Medical Technologist - $1,894 per week in Aurora, CO

    Travel Medical Technologist - $1,894 per week in Aurora, CO

    AlliedTravelCareers • Denver, Colorado, US
    Full-time +1
    AlliedTravelCareers is working with Infojini Healthcare to find a qualified Medical Technologist in Aurora, Colorado, 80045!. Medical Technologist travel Laboratory needed in Aurora, Colorado.Self A...Show more
    Last updated: 6 days ago • Promoted
    Travel Medical Technologist - $1,390 to $1,541 per week in Denver, CO

    Travel Medical Technologist - $1,390 to $1,541 per week in Denver, CO

    AlliedTravelNetwork • Denver, CO, US
    Full-time
    AlliedTravelNetwork is working with LRS Healthcare to find a qualified Medical Technologist in Denver, Colorado, 80220!.Ready to start your next travel adventure? LRS Healthcare offers a full benef...Show more
    Last updated: 9 days ago • Promoted
    Travel Surgical Tech - $1,053 to $1,120 per week in Thornton, CO

    Travel Surgical Tech - $1,053 to $1,120 per week in Thornton, CO

    AlliedTravelNetwork • Thornton, CO, US
    Full-time
    AlliedTravelNetwork is working with Fusion Medical Staffing to find a qualified Surg Tech in Thornton, Colorado, 80229!.Facility in Thornton, Colorado. Fusion Medical Staffing is seeking a skilled S...Show more
    Last updated: 17 days ago • Promoted
    Travel Cath Lab Tech - $2,711 to $3,030 per week in Castle Rock, CO

    Travel Cath Lab Tech - $2,711 to $3,030 per week in Castle Rock, CO

    AlliedTravelCareers • Castle Rock, CO, US
    Full-time
    AlliedTravelCareers is working with Prime Time Healthcare to find a qualified Cath Lab Tech in Castle Rock, Colorado, 80104!. Now Hiring : Allied Healthcare Cath Lab - Castle Rock, CO.Contact us for ...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Medical-Surgical - $1,505 to $1,669 per week in Aurora, CO

    Travel Nurse RN - Medical-Surgical - $1,505 to $1,669 per week in Aurora, CO

    TravelNurseSource • Denver, Colorado, US
    Full-time
    TravelNurseSource is working with LRS Healthcare to find a qualified Med / Surg RN in Aurora, Colorado, 80012!.Ready to start your next travel adventure? LRS Healthcare offers a full benefits package...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse - RN - LD - Labor and Delivery

    Travel Nurse - RN - LD - Labor and Delivery

    Medical Solutions • Thornton, CO, US
    Full-time
    Medical Solutions is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Thornton, CO. Shift : 3x12 hr nights Start Date : ASAP Duration : 13 weeks.A facili...Show more
    Last updated: 11 days ago • Promoted
    Medical Science Liaison - Neuro-Oncology - Central (Remote)

    Medical Science Liaison - Neuro-Oncology - Central (Remote)

    Jazz Pharmaceuticals • Lakewood, CO, US
    Remote
    Full-time
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients ...Show more
    Last updated: 24 days ago • Promoted
    Travel Nurse RN - Labor and Delivery - $2,246 per week

    Travel Nurse RN - Labor and Delivery - $2,246 per week

    Healthcare Support • Thornton, CO, US
    Full-time +1
    Healthcare Support is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Thornton, Colorado.Job Description & Requirements. Healthcare Support Job ID #461743.Pay package is bas...Show more
    Last updated: 25 days ago • Promoted
    Travel Cath Lab Tech - $2,711 to $3,030 per week in Castle Rock, CO

    Travel Cath Lab Tech - $2,711 to $3,030 per week in Castle Rock, CO

    Prime Time Healthcare • Castle Rock, CO, US
    Full-time
    Now Hiring : Allied Healthcare Cath Lab - Castle Rock, CO.Contact us for Pay Information.Actual amount dependent upon market adjustments. Are you a passionate Allied Healthcare professional looking f...Show more
    Last updated: 9 days ago • Promoted
    Travel Medical Technologist

    Travel Medical Technologist

    Trustaff Allied • Denver, CO, US
    Full-time
    Trustaff Allied is seeking a travel Medical Technologist for a travel job in Denver, Colorado.Job Description & Requirements. As a Medical Technologist, your responsibilities include testing and...Show more
    Last updated: 19 days ago • Promoted
    Travel Labor & Delivery Registered Nurse - $2,286 per week

    Travel Labor & Delivery Registered Nurse - $2,286 per week

    Lifeline Medical Staffing • Thornton, CO, US
    Full-time
    Lifeline Medical Staffing is seeking a travel nurse RN Labor and Delivery for a travel nursing job in Thornton, Colorado. Job Description & Requirements.Lifeline Medical Staffing Job ID #71517931.Pa...Show more
    Last updated: 25 days ago • Promoted
    Travel Medical Technologist - $1,390 to $1,541 per week in Denver, CO

    Travel Medical Technologist - $1,390 to $1,541 per week in Denver, CO

    LRS Healthcare • Denver, CO, US
    Full-time
    Ready to start your next travel adventure? LRS Healthcare offers a full benefits package, 24 / 7 support, and a responsive, traveler-first culture. What are you waiting for? Apply today!.Valid license...Show more
    Last updated: 9 days ago • Promoted