Talent.com
Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

Syneos Health / inVentiv Health Commercial LLCDetroit, MI, 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

Sr Principal / Principal Medical Writer (Publication Strategy / Planning) - East Coast Preferred - Single Sponsor

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 complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and 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.
  • Advises clients and study teams on data presentation and production strategies to ensure that client objectives / expectations are met and quality standards are maintained.
  • Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
  • Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained.
  • 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 relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Works with staff across company to advance company priorities.
  • Performs online clinical literature searches and complies with copyright requirements.
  • Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Contributes to changes to internal process, standard practices, and capabilities.
  • Mentors and leads less experienced medical writers on complex documents.
  • Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Engages externally with industry groups on industry initiatives.
  • Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Contributes to bid projections.
  • Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables.
  • Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects.
  • 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 :

    $95,000.00 - $175,700.00

    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

    Principal Medical Writer • Detroit, MI, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $1,303 to $1,505 per week in Commerce Charter Township, MI

    Travel Nurse RN - Medical-Surgical - $1,303 to $1,505 per week in Commerce Charter Township, MI

    TravelNurseSourceCommerce Charter Township, MI, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with National Staffing Solutions to find a qualified Med / Surg RN in Commerce Charter Township, Michigan, 48382!. Details of the RN - Medical Surgical (MS) opening in Com...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Medical Assistant (MA) - $713 to $823 per week in Bay City, MI

    Travel Medical Assistant (MA) - $713 to $823 per week in Bay City, MI

    AlliedTravelCareersWarren, Michigan, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with National Staffing Solutions to find a qualified Medical Assistant in Bay City, Michigan, 48708!. Details of the MA opening in Bay City, MI : .Anticipated Start Date...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Medical Assistant (MA) - $756 per week in Flint, MI

    Travel Medical Assistant (MA) - $756 per week in Flint, MI

    AlliedTravelCareersWarren, Michigan, US
    serp_jobs.job_card.full_time +1
    AlliedTravelCareers is working with Infojini Healthcare to find a qualified Medical Assistant in Flint, Michigan, 48532!. Medical Assistant travel Medical Assistant needed in Flint, Michigan.Self As...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Psychiatric

    Travel Nurse RN - Psychiatric

    Planet HealthcareNew Baltimore, MI, US
    serp_jobs.job_card.full_time
    Planet Healthcare is seeking a travel nurse RN Psychiatric for a travel nursing job in New Baltimore, Michigan.Job Description & Requirements. Planet Healthcare Job ID #73129196.Pay package is b...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $1,481 to $1,655 per week in Commerce, MI

    Travel Nurse RN - Medical-Surgical - $1,481 to $1,655 per week in Commerce, MI

    TravelNurseSourceCommerce, MI, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Prime Time Healthcare to find a qualified Med / Surg RN in Commerce, Michigan, 48382!.Now Hiring : RN Med Surg - Commerce, MI. Contact us for Pay Information.Actual am...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $1,427 per week in Commerce Township, MI

    Travel Nurse RN - Medical-Surgical - $1,427 per week in Commerce Township, MI

    TravelNurseSourceCommerce Township, MI, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with FlexCare to find a qualified Med / Surg RN in Commerce Township, Michigan, 48382!.FlexCare is a nationwide leader in the staffing of travel nurses and clinicians.Wit...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Medical Assistant (MA) - $806 to $841 per week in Petoskey, MI

    Travel Medical Assistant (MA) - $806 to $841 per week in Petoskey, MI

    AlliedTravelCareersDetroit, Michigan, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with Greenstaff Medical to find a qualified Medical Assistant in Petoskey, Michigan, 49770!. Temp - Medical Assistant (MA) - - (Days) Bad Axe, MI.Why Choose Greenst...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Medical Assistant (MA) in Chesterfield, MI

    Travel Medical Assistant (MA) in Chesterfield, MI

    AlliedTravelCareersWarren, Michigan, US
    serp_jobs.job_card.full_time +1
    AlliedTravelCareers is working with Lancesoft Inc.Medical Assistant in Chesterfield, Michigan, 48047!.We are currently seeking qualified candidates for Medical Assistant. Shift 5x8 Rotating, 12 : 00 : 0...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Behavioral Health

    Travel Nurse RN - Behavioral Health

    First Connect HealthNew Baltimore, MI, US
    serp_jobs.job_card.full_time
    First Connect Health is seeking a travel nurse RN Behavioral Health for a travel nursing job in New Baltimore, Michigan.Job Description & Requirements. Behavioral Health / Psychiatric RN.Minimum...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Registered Nurse - Medical-Surgical - $1,668 per week in Commerce Township, MI

    Travel Registered Nurse - Medical-Surgical - $1,668 per week in Commerce Township, MI

    TravelNurseSourceCommerce Township, MI, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Care Career to find a qualified Med / Surg RN in Commerce Township, Michigan, 48382!.In general, M / S nurses provide care and treatment to ill, injured, and recoverin...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Device Sales – Paid Internship

    Medical Device Sales – Paid Internship

    Medical Sales CollegeHarrison Township, Michigan, US
    serp_jobs.job_card.internship
    Description Medical Device Sales - Paid Internship Looking for a rewarding and lucrative career in the medical sales industry? Our paid Internship may be the right path for you! Here are just some ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical in Commerce Township, MI

    Travel Nurse RN - Medical-Surgical in Commerce Township, MI

    TravelNurseSourceCommerce Township, MI, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Titan Medical Group to find a qualified Med / Surg RN in Commerce Township, Michigan, 48382!. Commerce Township, MI, United States.Titan Medical is looking for travel...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Psychiatric

    Travel Nurse RN - Psychiatric

    Stability HealthcareNew Baltimore, MI, US
    serp_jobs.job_card.full_time
    Stability Healthcare is seeking a travel nurse RN Psychiatric for a travel nursing job in New Baltimore, Michigan.Job Description & Requirements. Stability Healthcare is looking for a Psych RN c...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical in Pontiac, MI

    Travel Nurse RN - Medical-Surgical in Pontiac, MI

    TravelNurseSourcePontiac, MI, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with Patterns LLC to find a qualified Med / Surg RN in Pontiac, Michigan, 48340!.Establishes a therapeutic relationship and creates a detailed plan of care with the patie...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Principal Medical Writer

    Principal Medical Writer

    Syneos Health / inVentiv Health Commercial LLCDetroit, MI, United States
    serp_jobs.job_card.full_time
    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 ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Psych - $1,570 per week in New Baltimore, MI

    Travel Nurse RN - Psych - $1,570 per week in New Baltimore, MI

    TravelNurseSourceNew Baltimore, MI, US
    serp_jobs.job_card.full_time +1
    TravelNurseSource is working with Core Medical Group to find a qualified Psych RN in New Baltimore, Michigan, 48047!.Client in MI seeking Registered Nurse : Psychiatric. We are looking for a healthca...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Nurse RN - Medical-Surgical - $1,242 to $1,377 per week in Commerce Township, MI

    Travel Nurse RN - Medical-Surgical - $1,242 to $1,377 per week in Commerce Township, MI

    TravelNurseSourceCommerce Township, MI, US
    serp_jobs.job_card.full_time
    TravelNurseSource is working with LRS Healthcare to find a qualified Med / Surg RN in Commerce Township, Michigan, 48382!. Ready to start your next travel adventure? LRS Healthcare offers a full benef...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Sales Rep (Work from home) - urgent hire!

    Sales Rep (Work from home) - urgent hire!

    Altig / AO Globe LifeAmherstburg, Ontario
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    If you’re passionate about making a difference and want to turn that passion into a fulfilling career, we want to hear from you. A Sales Representative plays a crucial role in driving business...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30