Talent.com
Sr Principal Communication/ Publication Strategy - Single Sponsor - CMPP Certified
Sr Principal Communication/ Publication Strategy - Single Sponsor - CMPP CertifiedSyneos Health/ inVentiv Health Commercial LLC • Honolulu, HI, United States
Sr Principal Communication / Publication Strategy - Single Sponsor - CMPP Certified

Sr Principal Communication / Publication Strategy - Single Sponsor - CMPP Certified

Syneos Health / inVentiv Health Commercial LLC • Honolulu, HI, United States
Hace 16 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Sr Principal Communication / Publication Strategy - Single Sponsor - CMPP Certified

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.

    Crear una alerta de empleo para esta búsqueda

    Sr Principal • Honolulu, HI, United States

    Ofertas relacionadas
    Sr. PM Director

    Sr. PM Director

    Leidos Inc • Fort Shafter, HI, United States
    A tiempo completo
    Leidos is a FORTUNE 500 company bringing a mix of innovative technology and sector expertise to customers in the national security, engineering, and the health industries.At Leidos, we deliver inno...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Strategic Leader, Commercial Management

    Strategic Leader, Commercial Management

    HDR • Honolulu, HI, United States
    A tiempo completo
    A leading construction and design firm is seeking a Commercial Management Director in Honolulu, Hawaii.The role involves leadership, strategy, and driving initiatives within the commercial manageme...Mostrar más
    Última actualización: hace 9 días • Oferta promocionada
    Dean of the School of Business and Communication

    Dean of the School of Business and Communication

    Chaminade University of Honolulu • Honolulu, HI, United States
    A tiempo completo
    Dean of the School of Business and Communication.Dean of the School of Business and Communication.Chaminade University of Honolulu. Dean of the School of Business and Communication.Be among the firs...Mostrar más
    Última actualización: hace 13 días • Oferta promocionada
    Director, Corporate Communications

    Director, Corporate Communications

    RxBenefits • Honolulu, HI, United States
    A tiempo completo
    RxBenefits Corporate Communications team is seeking a.Director, Corporate Communications.Working closely with the HR and executive leadership teams, this role will oversee the development and execu...Mostrar más
    Última actualización: hace 12 días • Oferta promocionada
    Information Systems Programming Professional II

    Information Systems Programming Professional II

    Hsfcu Online • Honolulu, HI, United States
    A tiempo completo
    Information Systems Programming Professional II.HSFCU Headquarters, 333 Queen Street, Honolulu, Hawaii, United States of America. Posted Tuesday, September 2, 2025 at 4 : 00 PM.Hawaii State FCU is loo...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Sr. Product Marketing Manager

    Sr. Product Marketing Manager

    Oracle • Honolulu, HI, United States
    A tiempo completo
    Product Marketing Manager - Oracle Fusion Data Intelligence.As a Product Marketing Manager for Oracle's Fusion Data Intelligence, you will be the strategic bridge between product innovation and mar...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Director of Data and AI Strategy

    Director of Data and AI Strategy

    Confidential • Honolulu, HI, United States
    A tiempo completo
    Director of Data and AI Strategy.Join a mission-driven organization devoted to providing vital social services to the community. Be part of a team that truly makes a difference!.Non-Profit Organizat...Mostrar más
    Última actualización: hace 19 días • Oferta promocionada
    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based

    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based

    Syneos Health / inVentiv Health Commercial LLC • Honolulu, HI, United States
    Teletrabajo
    A tiempo completo
    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to acceler...Mostrar más
    Última actualización: hace 11 días • Oferta promocionada
    Principal Medical Writer - Regulatory Submission Documents

    Principal Medical Writer - Regulatory Submission Documents

    Syneos Health / inVentiv Health Commercial LLC • Honolulu, HI, United States
    A tiempo completo
    Principal Medical Writer - Regulatory Submission Documents.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate uni...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    Life Sciences Comm Manager

    Life Sciences Comm Manager

    FUJIFILM Corporation • Honolulu, HI, United States
    A tiempo completo
    The Life Sciences Communications Business Partner plans, develops, directs and executes strategic communications and branding programs that enhance reputation, engage stakeholders, and drive overal...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior PR Account Lead — Strategy & Media Relations

    Senior PR Account Lead — Strategy & Media Relations

    Anthology Marketing Group, Inc. • Honolulu, HI, United States
    A tiempo completo
    A marketing firm in Hawaii seeks a Senior Account Executive to be a primary client contact, ensuring high-level strategic thinking on assigned accounts. Responsibilities include developing PR strate...Mostrar más
    Última actualización: hace 3 días • Oferta promocionada
    Hybrid Commercial Leadership Curriculum Director

    Hybrid Commercial Leadership Curriculum Director

    Pfizer Belgium • Honolulu, HI, United States
    A tiempo completo
    A leading pharmaceutical company is seeking a Commercial Leadership Training Director responsible for developing training programs for commercial leaders. The role entails designing curriculum and c...Mostrar más
    Última actualización: hace 5 días • Oferta promocionada
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

    Syneos Health / inVentiv Health Commercial LLC • Honolulu, HI, United States
    A tiempo completo
    Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Sr. PM Director

    Sr. PM Director

    Leidos • Honolulu, HI, United States
    A tiempo completo
    Leidos is a FORTUNE 500 company bringing a mix of innovative technology and sector expertise to customers in the national security, engineering, and the health industries.At Leidos, we deliver inno...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada