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 • Philadelphia, PA, 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 • Philadelphia, PA, 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 • Philadelphia, PA, United States

    [internal_linking.similar_jobs]
    Specialist, Partnerships

    Specialist, Partnerships

    Comcast • Philadelphia, PA, US
    [job_card.full_time]
    Specialist, Strategic Partnerships & Philanthropy.Comcast brings together the best in media and technology.We drive innovation to create the world's best entertainment and online experiences.As a F...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Corporate Communications & Content Specialist

    Corporate Communications & Content Specialist

    Signature Consultants • USA, Pennsylvania, Philadelphia
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Corporate Communications & Content Specialist.High-volume internal / external communications with Executive-Level visibility. Writing is the primary function (executive talking points, social medi...[show_more]
    [last_updated.last_updated_variable_days]
    Career Transition Specialist Specialist

    Career Transition Specialist Specialist

    Adams and Associates, Inc. • Philadelphia, PA, US
    [job_card.full_time]
    Responsible to provide students with transitional support and placement services leading to full-time jobs, higher education or advanced training. Works cooperatively with Career Technical Training ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Principal, Strategy and Accounts

    Principal, Strategy and Accounts

    Middle Seat • Philadelphia, PA, US
    [filters.remote]
    [job_card.full_time]
    [filters_job_card.quick_apply]
    This position is not a part of the bargaining unit.Vice President, Client Strategy.Preference for New York City / Washington, DC / Philadelphia, PA. Occasional in-person work and travel required.The...[show_more]
    [last_updated.last_updated_30]
    Assistant Principal of School Culture – 2026 / 2027 School Year

    Assistant Principal of School Culture – 2026 / 2027 School Year

    Mastery Schools • Philadelphia, PA, US
    [job_card.full_time]
    Founded in 2001, Mastery Schools is a public charter network of 23 K-12 schools in Philadelphia and Camden, serving more than 14,000 students. At Mastery, we’re on a mission to provide all students ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Marketing / Outreach Volunteer

    Marketing / Outreach Volunteer

    Brighten A Day • Philadelphia, PA, United States
    [job_card.full_time]
    Marketing & Outreach Volunteer.We’re looking for enthusiastic.Marketing & Outreach Volunteers.If you’re creative, outgoing, and interested in communications or social media, this is a great way to....[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Engagement Strategy

    Director, Engagement Strategy

    Digitas Health • Philadelphia, PA, US
    [job_card.full_time]
    Digitas Health is the Agency of Now : the first global connected-health agency, purpose-built for marketing today.Digitas Health specializes in helping health brands navigate a complex and shifting ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Sr. Manager, FP&A - Marketing & Ecommerce

    Sr. Manager, FP&A - Marketing & Ecommerce

    Five Below • Philadelphia, PA, US
    [job_card.full_time]
    At Five Below our growth is a result of the people who embrace our purpose : We know life is way better when you are free to Let Go & Have Fun in an amazing experience, filled with unlimited possibi...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Strategic Partnership Associate (Updated 10 / 25)

    Strategic Partnership Associate (Updated 10 / 25)

    Design Science Group LLC • Philadelphia, PA, US
    [job_card.full_time]
    Design Science is a human factors research firm improving the usability and safety of medical devices.We're seeking a Strategic Partnership Associate (SPA) to recruit paid participants for user...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Corporate Communications & Content Specialist

    Corporate Communications & Content Specialist

    Dexian - DISYS • Philadelphia, Pennsylvania, United States
    [job_card.full_time]
    Corporate Communications & Content Specialist Philadelphia, PA 12 + Months Focus : High-volume internal / external communications with Executive-Level visibility. Writing is the primary function (execu...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Partners in Performance - Performance Strategy Senior Principal

    Partners in Performance - Performance Strategy Senior Principal

    Pennsylvania Staffing • Philadelphia, PA, US
    [job_card.full_time]
    Partners In Performance Associate Principal.This role is with our Partners In Performance team, part of Accenture.Partners In Performance, Part Of Accenture is a global management consulting firm w...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director of Marketing & Communications (Lottery & Gaming)

    Director of Marketing & Communications (Lottery & Gaming)

    Office of The Chief Financial Officer • Philadelphia, PA, United States
    [job_card.full_time]
    Government of the District of Columbia.Office of the Chief Financial Officer (OCFO).Director of Marketing & Communications. Locations : Washington, DC (Hybrid).The Office of the Chief Financial Offic...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Sr. Manager / Associate Director, Global Recruitment Marketing

    Sr. Manager / Associate Director, Global Recruitment Marketing

    Syneos Health / inVentiv Health Commercial LLC • Newtown, PA, United States
    [job_card.full_time]
    You're driven, resourceful, and above all else - remarkably smart.You are the first to roll up your.Syneos Health is seeking a strategic and hands-on recruitment marketing leader to elevate our glo...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Corporate Affairs / Communications - Technology Business Partner

    Associate Director, Corporate Affairs / Communications - Technology Business Partner

    Philadelphia Staffing • Philadelphia, PA, US
    [job_card.full_time]
    Communications Business Partner.Together with the Director of Communications for • / dxg, the Communications Business Partner serves as the strategic communications advisor for the central product te...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Specialist, Contracting Strategy and Operations

    Senior Specialist, Contracting Strategy and Operations

    J&J Family of Companies • Horsham, PA, US
    [job_card.full_time]
    Senior Specialist, Contracting Strategy And Operations.Johnson & Johnson is currently seeking a Senior Specialist, Contracting Strategy and Operations. This position will be primarily based in Horsh...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted]
    Director - Patient Strategy, Anti-Infectives

    Director - Patient Strategy, Anti-Infectives

    GSK • Philadelphia, PA, US
    [job_card.full_time]
    Director Patient Strategy, Anti-Infectives.Are you looking for a challenging commercial role that allows you to influence a broad range of global leaders and helping to shape regional marketing sol...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Sr. Director, Clinical Science

    Sr. Director, Clinical Science

    Apellis • Philadelphia, PA, US
    [job_card.full_time]
    Director, Clinical Science, is a key member of our clinical development team, contributing to and providing leadership on the development and execution of the clinical strategy for current and futu...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Sr. Manager, Strategic Finance-Xumo

    Sr. Manager, Strategic Finance-Xumo

    USA Jobs • Philadelphia, PA, US
    [job_card.full_time]
    Xumo, a joint venture between Comcast and Charter Communications, was formed to develop and offer a next-generation streaming platform for the entire entertainment industry.The company consists of ...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]