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 • Westerville, OH, 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 • Westerville, OH, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
  • serp_jobs.filters.remote
job_description.job_card.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.

    serp_jobs.job_alerts.create_a_job

    Medical Writer • Westerville, OH, United States

    Job_description.internal_linking.related_jobs
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    PRIDE Health • Columbus, OH, US
    serp_jobs.job_card.full_time
    PRIDE Health is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio.Job Description & Requirements. Pay package is based on 12 hour shifts and 36.PRIDE Heal...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    Prime Staffing • Columbus, OH, US
    serp_jobs.job_card.permanent
    Prime Staffing is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio.Job Description & Requirements. Prime Staffing Job ID #35075820.Pay package is based o...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    GHR Healthcare - Travel Division • Columbus, OH, US
    serp_jobs.job_card.full_time
    GHR Healthcare - Travel Division is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio. Job Description & Requirements.GHR Healthcare - Travel Division Job...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    Assured Nursing • Columbus, OH, US
    serp_jobs.job_card.full_time
    Assured Nursing is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio.Job Description & Requirements. Assured Nursing is currently seeking a.CC96901 | Jame...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    PRN Healthcare • Columbus, OH, US
    serp_jobs.job_card.full_time
    PRN Healthcare is seeking a travel nurse RN Telemetry Med Surg for a travel nursing job in Columbus, Ohio.Job Description & Requirements. PRN Healthcare Job ID #1476704.Pay package is based on 1...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    Arrow Healthcare Staffing • Columbus, OH, US
    serp_jobs.job_card.full_time
    Arrow Healthcare Staffing is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio.Job Description & Requirements. Arrow Healthcare Staffing Job ID #17509777....serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $1,398 to $1,550 per week in Milford, DE

    Travel Nurse RN - Medical-Surgical - $1,398 to $1,550 per week in Milford, DE

    TravelNurseSource • Delaware, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with LRS Healthcare to find a qualified Med / Surg RN in Milford, Delaware, 19963!.Ready to start your next travel adventure? LRS Healthcare offers a full benefits packag...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Nurse RN - Correctional - $1,140 per week in Orient, OH

    Travel Nurse RN - Correctional - $1,140 per week in Orient, OH

    TravelNurseSource • Orient, OH, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with American Medical Staffing to find a qualified Correctional RN in Orient, Ohio, 43146!.We’re living in the new normal. Lives and careers look different today.So why ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Local Contract Medical Technologist

    Local Contract Medical Technologist

    American Medical Staffing • Orient, OH, US
    serp_jobs.job_card.full_time
    American Medical Staffing is seeking a local contract Medical Technologist for a local contract job in Orient, Ohio.Job Description & Requirements. We’re living in the new normal.Lives and...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Part-time Behavioral Health Medical Director - Ohio

    Part-time Behavioral Health Medical Director - Ohio

    Buckeye Community Health Plan • Groveport, OH, US
    serp_jobs.job_card.full_time +1
    You could be the one who changes everything for our 28 million members as a clinical professional on our Medical Management / Health Services team. Centene is a diversified, national organization offe...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    GHR Healthcare - PH Division • Columbus, OH, US
    serp_jobs.job_card.full_time
    GHR Healthcare - PH Division is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio. Job Description & Requirements.Planet Healthcare Job ID #74423886.Pay p...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel MRI Tech - $2,237 per week in Westerville, OH

    Travel MRI Tech - $2,237 per week in Westerville, OH

    AlliedTravelCareers • Westerville, OH, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with Medical Solutions to find a qualified MRI Tech in Westerville, Ohio, 43081!.A facility in Westerville, OH is seeking its next amazing MRI Technologist.Read on if...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel MRI Tech - $2,237 per week in Westerville, OH

    Travel MRI Tech - $2,237 per week in Westerville, OH

    Medical Solutions • Columbus, Ohio, US
    serp_jobs.job_card.full_time
    A facility in Westerville, OH is seeking its next amazing MRI Technologist.Read on if this sounds like your perfect fit!. Nurses and allied healthcare professionals are in high demand nationwide, an...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    CrossMed • Columbus, OH, US
    serp_jobs.job_card.full_time
    CrossMed is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio.Job Description & Requirements. At CrossMed Healthcare Staffing, we aim to create lasting im...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    GLC On-The-Go • Columbus, OH, US
    serp_jobs.job_card.full_time
    GLC On-The-Go is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio.Job Description & Requirements. RN Med Surg, Telemetry - Columbus, OH - 13-week contrac...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Travel MRI Tech - $2,237 per week in Westerville, OH

    Travel MRI Tech - $2,237 per week in Westerville, OH

    AlliedTravelNetwork • Westerville, OH, US
    serp_jobs.job_card.full_time
    AlliedTravelNetwork is working with Medical Solutions to find a qualified MRI Tech in Westerville, Ohio, 43081!.A facility in Westerville, OH is seeking its next amazing MRI Technologist.Read on if...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Corrections Medical-Surgical Telemetry RN

    Travel Corrections Medical-Surgical Telemetry RN

    Excel Medical Staffing • Columbus, OH, US
    serp_jobs.job_card.full_time
    Excel Medical Staffing is seeking a travel nurse RN Med Surg / Telemetry for a travel nursing job in Columbus, Ohio.Job Description & Requirements. Excel is seeking highly skilled healthcare pro...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Travel Cath Lab Tech - $2,220 to $2,462 per week in Lewes, DE

    Travel Cath Lab Tech - $2,220 to $2,462 per week in Lewes, DE

    LRS Healthcare • Delaware, US
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted