Talent.com
Principal Medical Writer - Regulatory Submission Documents
Principal Medical Writer - Regulatory Submission DocumentsSyneos Health/ inVentiv Health Commercial LLC • Salt Lake City, UT, United States
Principal Medical Writer - Regulatory Submission Documents

Principal Medical Writer - Regulatory Submission Documents

Syneos Health / inVentiv Health Commercial LLC • Salt Lake City, UT, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Principal Medical Writer - Regulatory Submission Documents

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

  • Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
  • Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
  • Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, 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
  • Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
  • Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
  • Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
  • Review statistical analysis plans and table / figure / listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
  • Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
  • Perform online clinical literature searches and comply with copyright requirements
  • Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
  • Mentor and lead less experienced medical writers on complex projects
  • Develop deep expertise on key topics in the industry and regulatory requirements
  • Work within budget specifications for assigned projects
  • Qualifications :

  • Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
  • 3-5 years of relevant experience in science, technical, or medical writing
  • Experience working in the biopharmaceutical, device, or contract research organization industry required
  • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and / or good publication practices strongly required
  • Experience writing relevant document types required
  • Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
  • Necessary Skills :

  • Strong presentation, proofreading, collaborative, and interpersonal skills
  • Strong project and time management skills
  • Strong proficiency in MS Office
  • Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information
  • 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 • Salt Lake City, UT, United States

    Job_description.internal_linking.related_jobs
    Travel Nurse RN - Medical-Surgical - $1,822 to $2,037 per week in Saratoga Springs, UT

    Travel Nurse RN - Medical-Surgical - $1,822 to $2,037 per week in Saratoga Springs, UT

    TravelNurseSource • Saratoga Springs, UT, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Prime Time Healthcare to find a qualified Med / Surg RN in Saratoga Springs, Utah, 84043!. Now Hiring : RN Med Surg - Saratoga Springs, UT.Contact us for Pay Informati...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Physician - Family Medicine

    Physician - Family Medicine

    Trinity Health • Saratoga Springs, US
    serp_jobs.job_card.full_time
    Peters Health Partners Medical Associates is thrilled to offer a full-time Family Medicine physician position at our brand-new primary care practice located at 631 Maple Ave in Wilton, NY.This is a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Donor Center Phlebotomist

    Donor Center Phlebotomist

    American Red Cross • Lehi, UT, United States
    serp_jobs.job_card.full_time
    Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Medical Affairs Field Director

    Medical Affairs Field Director

    Scientific Search • Salt Lake City, UT, US
    serp_jobs.job_card.full_time
    A commercial-stage biotechnology company developing cell and immunotherapy products to eliminate cancerous or infected cells. Engage in the exchange of scientific data and education of health care p...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Clinical Research Associate, Oncology

    Clinical Research Associate, Oncology

    ICON Strategic Solutions • Salt Lake City, UT, US
    serp_jobs.job_card.full_time
    Clinical Research Associate - Oncology - Colorado.ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Assistant Professor, Associate Professor, or Professor – Tenure Track in the Department of Dermatology

    Assistant Professor, Associate Professor, or Professor – Tenure Track in the Department of Dermatology

    University of Utah Department of Dermatology • Salt Lake City, US
    serp_jobs.job_card.full_time
    Tenure-Track Faculty Position in the Department of Dermatology : Allergy and Immunology .Assistant Professor, Associate Professor, or Professor – Tenure Track .Rank dependent upon ex...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Local Medical Equipment Delivery Driver

    Local Medical Equipment Delivery Driver

    Rotech Healthcare Inc. • Layton, UT, United States
    serp_jobs.job_card.full_time
    Join a Leader in Home Healthcare.As a national leader in ventilators, oxygen therapy, sleep apnea treatment, wound care, diabetic solutions, and other home medical equipment, we empower patients to...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Clinic Director - Physical Therapist (Outpatient Orthopedics)

    Clinic Director - Physical Therapist (Outpatient Orthopedics)

    Tayloright Placement • Layton, UT, US
    serp_jobs.job_card.full_time
    Clinic Director – Physical Therapist (DPT).Aspen Ridge Physical Therapy | Layton, UT.Full-Time • Outpatient Orthopedics • Leadership Role. Aspen Ridge Physical Therapy is hiring an e...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Remote Financial Expert - AI Trainer ($150 per hour)

    Remote Financial Expert - AI Trainer ($150 per hour)

    Mercor • Lehi, Utah, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    UK / Canada / Europe / Singapore / Dubai / Australia-based • •Investment Banking or Private Equity Experts • • for a research project with a leading foundational model AI lab. You are a good fit if you : - Have •...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    bioMerieux Inc. • Salt Lake City, UT, United States
    serp_jobs.job_card.full_time
    An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughou...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Freelance Writer

    Freelance Writer

    Outlier • West Valley City, UT, United States
    serp_jobs.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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Oral Surgery Partnership

    Oral Surgery Partnership

    HealthEcareers - Client • Farmington, UT, USA
    serp_jobs.job_card.full_time
    We’re excited to offer an immediate opportunity for an oral surgeon to join our established practice in the northern Utah valley. This is an incredible opportunity to join a group of thriving OMS pr...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    DVM Medical Director - Co-Owner

    DVM Medical Director - Co-Owner

    Peoplepack LLC - Recruiting Solutions • Lehi, UT, US
    serp_jobs.job_card.full_time
    We are recruiting for an entrepreneurial Veterinarian leader who is interested in managing a NEW stand-alone GP hospital, as a co-owner, building and leading a veterinary team, while reaping the fi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Cardiology - General / Other in Lehi, UT

    Locum Physician (MD / DO) - Cardiology - General / Other in Lehi, UT

    LocumJobsNetwork • Lehi, UT, US
    serp_jobs.job_card.full_time
    LocumJobsNetwork is working with Weatherby Healthcare to find a qualified Cardiology MD in Lehi, Utah, 84043!.Weatherby can help you build a custom career plan, with multiple positions available fo...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Remote Financial Planner - AI Trainer ($150 per hour)

    Remote Financial Planner - AI Trainer ($150 per hour)

    Mercor • Lehi, Utah, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    UK / Canada / Europe / Singapore / Dubai / Australia-based • •Investment Banking or Private Equity Experts • • for a research project with a leading foundational model AI lab. You are a good fit if you : - Have •...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Inpatient Medical Medical Director - Child & Adolescent Psychiatry | Utah

    Inpatient Medical Medical Director - Child & Adolescent Psychiatry | Utah

    Jackson Physician Search • Salt Lake City, US
    serp_jobs.job_card.full_time
    An established pediatric behavioral health hospital is seeking a board certified or board eligible child psychiatrist to join their growing team. Situated in a thriving, fast-growing metro, Salt Lak...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Family Medicine Physician - St. Peter's Primary Care

    Family Medicine Physician - St. Peter's Primary Care

    Trinity Health • Saratoga Springs, US
    serp_jobs.job_card.full_time
    Peters Health Partners Medical Associates.This is an exciting opportunity to join an existing outpatient practice with strong patient demand and hospital affiliated practice support!.Congress Place...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Specimen Collector

    Specimen Collector

    Millennium Health • Sandy, UT, United States
    serp_jobs.job_card.full_time
    Full Time female Specimen Collector.Schedule : Full Time : Monday : 9 : 30 AM - 6 : 30 PM.Seeking : Female candidates required for observed collections of gender identified female patients.Help make a posi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted