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
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
  • [filters.remote]
[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.

    [job_alerts.create_a_job]

    Medical Writer • Denver, CO, United States

    [internal_linking.related_jobs]
    CRNA - Anesthesiology job available in Castle Rock, Colorado

    CRNA - Anesthesiology job available in Castle Rock, Colorado

    MPLT Healthcare • Castle Rock, CO, US
    [job_card.full_time]
    [show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel MRI Tech - $2,760 per week in Westminster, CO

    Travel MRI Tech - $2,760 per week in Westminster, CO

    AlliedTravelCareers • Westminster, CO, US
    [job_card.full_time]
    AlliedTravelCareers is working with Medical Solutions to find a qualified MRI Tech in Westminster, Colorado, 80021!.A facility in Westminster, CO is seeking its next amazing MRI Technologist.Read o...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Medical Social Worker - $2054 / Week

    Travel Medical Social Worker - $2054 / Week

    AMN Healthcare Allied • Thornton, CO, US
    [job_card.full_time]
    AMN Healthcare Allied is seeking an experienced Medical Social Worker for an exciting Travel Allied job in Thornton, CO.Shift : Inquire Start Date : ASAP Duration : 32 weeks Pay : $2054 / Week.Job Desc...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse RN - Labor & Delivery - $1,801 per week in Thornton, CO

    Travel Nurse RN - Labor & Delivery - $1,801 per week in Thornton, CO

    TravelNurseSource • Thornton, CO, US
    [job_card.full_time]
    TravelNurseSource is working with GQR Healthcare to find a qualified Labor / Delivery RN in Thornton, Colorado, 80229!.GQR Healthcare is representing a well-known health system seeking experienced La...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Physical Therapist (PT) - $1,613 to $1,813 per week in Castle Rock, CO

    Travel Physical Therapist (PT) - $1,613 to $1,813 per week in Castle Rock, CO

    AlliedTravelCareers • Castle Rock, CO, US
    [job_card.full_time] +1
    AlliedTravelCareers is working with Jackson Therapy Partners to find a qualified Physical Therapist (PT) in Castle Rock, Colorado, 80104!. Looking for a change of scenery and a chance to help others...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Medical-Surgical Telemetry RN - $1,451 per week

    Travel Medical-Surgical Telemetry RN - $1,451 per week

    CrossMed • Englewood, CO, United States
    [job_card.full_time]
    CrossMed is seeking a travel nurse RN Med Surg for a travel nursing job in Englewood, Colorado.Job Description & Requirements. At CrossMed Healthcare Staffing, we aim to create lasting impressions w...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    AI Trainer -Freelance Writer

    AI Trainer -Freelance Writer

    Outlier • Remote, CO, United States
    [filters.remote]
    [job_card.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.last_updated_variable_days] • [promoted]
    Manager, Medical & Professional Education

    Manager, Medical & Professional Education

    Cerapedics Inc • Broomfield, CO, US
    [job_card.full_time]
    Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safet...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse - RN - LD - Labor and Delivery

    Travel Nurse - RN - LD - Labor and Delivery

    Medical Solutions • Thornton, CO, US
    [job_card.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.last_updated_30] • [promoted]
    Associate Director / Director, Medical Science Liaison, Respiratory (Central Territory)

    Associate Director / Director, Medical Science Liaison, Respiratory (Central Territory)

    BESTMSLs • Denver, CO, US
    [job_card.full_time]
    Associate Director / Director, Medical Science Liaison, Respiratory (Central Territory).Central US covering NM, TX, OK, CO, KS, WY, NE, SD, ND, MT. A global biopharmaceutical organization is seeking...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel MRI Tech - $2,760 per week in Westminster, CO

    Travel MRI Tech - $2,760 per week in Westminster, CO

    Medical Solutions • Westminster, CO, US
    [job_card.full_time]
    A facility in Westminster, CO 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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Home-Based Freelance Writer

    Home-Based Freelance Writer

    Outlier • Remote, CO, United States
    [filters.remote]
    [job_card.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.last_updated_variable_days] • [promoted]
    Travel Medical-Surgical RN (Telemetry) - $1,825 per week

    Travel Medical-Surgical RN (Telemetry) - $1,825 per week

    Ethos Medical Staffing • Englewood, CO, United States
    [job_card.full_time]
    Ethos Medical Staffing is seeking a travel nurse RN Med Surg for a travel nursing job in Englewood, Colorado.Job Description & Requirements. Ethos Medical Staffing Job ID #34602044.Pay package is ba...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Project Manager

    Project Manager

    Global Medical Response • Greenwood Village, CO, United States
    [job_card.full_time]
    GMR) and its family of solutions are dedicated to delivering compassionate, quality medical care, primarily in the areas of emergency and patient relocation services. Here you'll embark in meaningfu...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Medical-Surgical RN - $1,764 per week

    Travel Medical-Surgical RN - $1,764 per week

    GHR Healthcare - Travel Division • Denver, CO, United States
    [job_card.full_time]
    GHR Healthcare - Travel Division is seeking a travel nurse RN Med Surg for a travel nursing job in Denver, Colorado.Job Description & Requirements. GHR Healthcare - Travel Division Job ID #74520773...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel MRI Tech - $2,760 per week in Westminster, CO

    Travel MRI Tech - $2,760 per week in Westminster, CO

    AlliedTravelNetwork • Westminster, CO, US
    [job_card.full_time]
    AlliedTravelNetwork is working with Medical Solutions to find a qualified MRI Tech in Westminster, Colorado, 80021!.A facility in Westminster, CO is seeking its next amazing MRI Technologist.Read o...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Remote Medical Appeals Specialist

    Remote Medical Appeals Specialist

    TEKsystems • Denver, CO, United States
    [filters.remote]
    [job_card.full_time]
    Medical Appeals Specialist (Fully Remote) •Make a measurable impact • by overturning denials, recovering missed revenue, and improving patient account outcomes. As a •Medical Appeals Specialist •, you...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Certified Registered Nurse Anesthetist (CRNA)

    Certified Registered Nurse Anesthetist (CRNA)

    AMN Healthcare • DOUGLAS, US
    [job_card.full_time]
    Job Description & Requirements.Certified Registered Nurse Anesthetist (CRNA).StartDate : ASAP Available Shifts : Regular 8 Pay Rate : $206. This facility is seeking a Certified Registered Nurse Anesthe...[show_more]
    [last_updated.last_updated_30] • [promoted]