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 • New York, NY, 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 • New York, NY, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

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.

    [job_alerts.create_a_job]

    Sr Principal • New York, NY, United States

    [internal_linking.related_jobs]
    Senior Manager, Press, VIP, & Partnerships

    Senior Manager, Press, VIP, & Partnerships

    Charlotte Tilbury • New York, NY, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    We are looking for a creative, talented and passionate .Manager, Press, VIP, & Partnerships.PR & Advocacy team in North America. They will be responsible for supporting the day-to-day a...[show_more]
    [last_updated.last_updated_variable_days]
    Public Adjuster

    Public Adjuster

    Metro Public Adjustment • Elberon, NJ, US
    [job_card.full_time] +1
    Public Adjuster (It’s Very Simple) This is for real!You’ve been waiting for this all your life!!!!! You Owe It To Yourself Commission based We will train the right people Part time $35,000 - $50,00...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Group Creative Director, Public Relations, Social & Influence

    Group Creative Director, Public Relations, Social & Influence

    The Ogilvy Group • New York, NY, United States
    [job_card.full_time]
    Ogilvy has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Bor...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager, Corporate Communications

    Senior Manager, Corporate Communications

    Capital Group • New York, NY, United States
    [job_card.full_time]
    I can succeed as a Senior Manager, Corporate Communications at Capital Group.Senior Manager, Corporate Communications.Capital Group's global narrative. This position is responsible for developing an...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Remote News Analysts, Reporters, and Journalists - AI Trainer ($60-$75 per hour)

    Remote News Analysts, Reporters, and Journalists - AI Trainer ($60-$75 per hour)

    Mercor • Clifton, New Jersey, US
    [filters.remote]
    [job_card.full_time]
    About the Role • • Mercor is seeking experienced • •News Analysts, Reporters, and Journalists • • to support a leading AI lab in advancing research and infrastructure for next-generation machine learnin...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Companionship & Care Aide

    Senior Companionship & Care Aide

    Papa Inc. • Avon-by-the-Sea, NJ, US
    [job_card.full_time]
    Papa facilitates these connections through its technology platform.We’re looking for kind, patient, and caring people who want to make a positive difference by offering companionship and ever...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Division of Infectious Diseases

    Director, Division of Infectious Diseases

    Hackensack Meridian Health • Neptune Township, US
    [job_card.full_time] +1
    Director, Division of Infectious Diseases.Jersey Shore University Medical Center.Hackensack Meridian Health – Neptune, New Jersey. Hackensack Meridian Health is seeking a Director, Division of...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director of PR and Communications (5 Month Contract)

    Director of PR and Communications (5 Month Contract)

    FoundRae • New York, NY, US
    [job_card.temporary]
    The FoundRae Collection is more than jewelry.The pieces are modern heirlooms, ones that allow the wearer to express something of themself to the world. The FoundRae collection is intended to become ...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Remote Medical Director

    Remote Medical Director

    HealthCare Support • Bronx, NY, US
    [filters.remote]
    [job_card.full_time] +1
    Monday–Friday schedule, professional collaboration, and the chance to make a meaningful impact by supporting quality behavioral health care across diverse patient populations.Serve as a key clinica...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Peer Specialist | Be a Life Changer | CRPA, CRPA-P | Islip, NY

    Peer Specialist | Be a Life Changer | CRPA, CRPA-P | Islip, NY

    Outreach : Building Healthy Lives • Yonkers, NY, US
    [job_card.full_time]
    Peer Specialist | Be a Life Changer | CRPA, CRPA-P.Recognized as a 2025 Top Workplace by City & State New York!.Imagine joining a vibrant team where your passion fuels positive change every day...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Health Practicum Placement Specialist (Academic Internship Specialist) - Health Equity, Adminis...

    Health Practicum Placement Specialist (Academic Internship Specialist) - Health Equity, Adminis...

    InsideHigherEd • Bronx, New York, United States
    [job_card.full_time] +1
    Health Practicum Placement Specialist (Academic Internship Specialist) - Health Equity, Administration, & Technology • •POSITION DETAILS • • Lehman College, of The City University of New York, ranks a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Medical Director of Psychiatric Emergency Screening Services

    Medical Director of Psychiatric Emergency Screening Services

    HealthEcareers - Client • Long Branch, NJ, USA
    [job_card.full_time]
    RWJBarnabas Health is Seeking a Medical Director of Psychiatric Emergency Screening Services Near the Jersey Shore!.RWJBarnabas Health, the largest integrated healthcare system in New Jersey, is cu...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Remote Research Study Contributor (Hiring Immediately)

    Remote Research Study Contributor (Hiring Immediately)

    Maxion Research • Tinton Falls, New Jersey, US
    [filters.remote]
    [job_card.part_time]
    Join Our Part-Time Research Studies Today!.Are you eager to earn extra income from the comfort of your home? We are looking for motivated individuals to participate in paid research studies includi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Side Hustle Project Lead

    Side Hustle Project Lead

    Finance Buzz • Neptune, New Jersey, US
    [job_card.full_time] +1
    We’re offering a role for someone who wants to lead their own side-income project in their spare time.You’ll explore various proven side hustles, select the ones that fit your lifestyle, and run th...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Oliver Wyman - Communications, Media & Technology Strategy Principal - USA

    Oliver Wyman - Communications, Media & Technology Strategy Principal - USA

    Marsh McLennan • New York, NY, US
    [job_card.full_time]
    The Principal position offers excellent career and growth opportunities for talented, highly motivated professionals with significant prior experience. As a professional member of our firm, your ini...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Communication Specialist

    Communication Specialist

    Axelon Services Corporation • Brooklyn, NY, US
    [job_card.full_time]
    Contractor must be able to come into the New York office once a month to gather content from the Senior Planet center.Older Adults Technology Services (OATS) from • • •s Communications team seeks to ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Publicist, SMP

    Publicist, SMP

    Macmillan Learning • New York, NY, United States
    [job_card.full_time]
    Martin's Publishing Group is seeking a Publicist to work on titles across the St.Martin's Press, Griffin and Essentials imprints. Reporting to the Associate Director of Publicity, this individual wi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Sr Principal Communication / Publication Strategy - Single Sponsor - CMPP Certified

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

    Syneos Health / inVentiv Health Commercial LLC • New York, NY, United States
    [job_card.full_time]
    Sr Principal Communication / Publication Strategy - Single Sponsor - CMPP Certified.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]