Talent.com
Principal Medical Writer - Regulatory Submission Documents
Principal Medical Writer - Regulatory Submission DocumentsSyneos Health/ inVentiv Health Commercial LLC • Indianapolis, IN, United States
Principal Medical Writer - Regulatory Submission Documents

Principal Medical Writer - Regulatory Submission Documents

Syneos Health / inVentiv Health Commercial LLC • Indianapolis, IN, 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 • Indianapolis, IN, United States

    Job_description.internal_linking.related_jobs
    Local Contract Labor and Delivery RN

    Local Contract Labor and Delivery RN

    Host Healthcare • Fishers, IN, US
    serp_jobs.job_card.full_time
    Host Healthcare is seeking a local contract nurse RN Labor and Delivery for a local contract nursing job in Fishers, Indiana. Job Description & Requirements.Pay package is based on 12 hour shift...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Emergency Medicine

    Emergency Medicine

    Team Health • Carmel, Indiana, US
    serp_jobs.job_card.full_time
    Emergency Medicine physician employment in Indiana : TeamHealth is seeking a dedicated emergency medicine (EM) physician to be a beacon of care in times of need. Make a difference where it matters m...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Medical-Surgical Registered Nurse

    Travel Medical-Surgical Registered Nurse

    Medical Solutions • Franklin, IN, US
    serp_jobs.job_card.full_time
    Medical Solutions is seeking a travel nurse RN Med Surg for a travel nursing job in Franklin, Indiana.Job Description & Requirements. We’re seeking talented healthcare professionals whose ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $1,918 to $2,071 per week in Franklin, IN

    Travel Nurse RN - Medical-Surgical - $1,918 to $2,071 per week in Franklin, IN

    TravelNurseSource • Franklin, IN, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Host Healthcare to find a qualified Med / Surg RN in Franklin, Indiana, 46131!.Host Healthcare is an award-winning travel healthcare company with an immediate openin...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Clinical Laboratories Business Development Manager - Great Lakes

    Clinical Laboratories Business Development Manager - Great Lakes

    QuidelOrtho • Indianapolis, IN, United States
    serp_jobs.job_card.full_time
    QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecula...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Gastroenterology

    Gastroenterology

    CompHealth • Columbus, Indiana, US
    serp_jobs.job_card.full_time
    Gastroenterology physician job in Indiana : Columbus has been called one of the best cities in the world for architecture lovers. There are also public art and galleries, shopping destinations, and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Behavioral Health RN

    Travel Behavioral Health RN

    Fusion Medical Staffing • Franklin, IN, US
    serp_jobs.job_card.full_time
    Travel Behavioral Health RN Company : Fusion Medical Staffing Location : Facility in Franklin, Indiana Job Details Fusion Medical Staffing is seeking a skilled Behavioral Health RN for a 13-week trav...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Locum Physician (MD / DO) - Hematology and Oncology in Columbus, IN

    Locum Physician (MD / DO) - Hematology and Oncology in Columbus, IN

    LocumJobsOnline • Columbus, IN, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with CompHealth to find a qualified Hematology and Oncology MD in Columbus, Indiana, 47201!.CompHealth services are always free to you. Let us do the heavy lifting and han...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Nurse RN - Med Surg

    Travel Nurse RN - Med Surg

    Core Medical Group • Carmel, IN, US
    serp_jobs.job_card.permanent +1
    Core Medical Group is seeking a travel nurse RN Med Surg for a travel nursing job in Carmel, Indiana.Job Description & Requirements. Core Medical Group Job ID #1339935.Pay package is based on 8 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Medical Director

    Medical Director

    Premise Health • Columbus, Indiana, US
    serp_jobs.job_card.full_time
    Medical Director physician job in Indiana : .Premise's mission is to help people get, stay, and be well.We hope you will join us in our mission and experience why amazing health starts with amazing ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Hematology-Oncology

    Hematology-Oncology

    CompHealth • Columbus, Indiana, US
    serp_jobs.job_card.full_time
    Hematology-Oncology physician job in Indiana : CompHealth services are always free to you.Let us do the heavy lifting and handle the headache of credentialing, travel, housing, and so much more.Wit...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Hematology-Oncology

    Hematology-Oncology

    Weatherby Healthcare • Columbus, Indiana, US
    serp_jobs.job_card.full_time
    Hematology-Oncology physician job in Indiana : Weatherby Healthcare is currently seeking a Hematology-Oncology Physician in IN. Interested? Give Weatherby a call today and speak with one of our spec...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Hematology and Oncology in Columbus, IN

    Locum Physician (MD / DO) - Hematology and Oncology in Columbus, IN

    LocumJobsNetwork • Columbus, IN, US
    serp_jobs.job_card.full_time +1
    LocumJobsNetwork is working with CompHealth to find a qualified Hematology and Oncology MD in Columbus, Indiana, 47201!.CompHealth services are always free to you. Let us do the heavy lifting and ha...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Medical Science Liaison - Neuro-Oncology - Central (Remote)

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

    Jazz Pharmaceuticals • Indianapolis, IN, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.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 and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Primary Care Physician

    Primary Care Physician

    Premise Health • Columbus, Indiana, US
    serp_jobs.job_card.full_time
    Primary Care Physician physician job in Indiana : .Premise's mission is to help people get, stay, and be well.We hope you will join us in our mission and experience why amazing health starts with am...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Medical Records

    Medical Records

    BrightSpring Health Services • Indianapolis, IN, United States
    serp_jobs.job_card.full_time
    Our operational team members focus on efficiently meeting the needs of our clients across various lines of business.If your passion is to ensure quality care to help our clients live their best lif...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • Indianapolis, IN, United States
    serp_jobs.job_card.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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Manager, Regulatory Affairs (Biosimilars)

    Senior Manager, Regulatory Affairs (Biosimilars)

    Fresenius Kabi USA, LLC • Indianapolis, IN, United States
    serp_jobs.job_card.full_time
    The Senior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted