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 • Minneapolis, MN, 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 • Minneapolis, MN, United States
15 days ago
Job type
  • Full-time
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.

    Create a job alert for this search

    Principal • Minneapolis, MN, United States

    Related jobs
    Strategic Business Initiatives Leader

    Strategic Business Initiatives Leader

    Medica • Minnetonka, MN, US
    Full-time
    Strategic Business Initiatives Leader.The Strategic Business Initiatives Leader is a strategic leadership role responsible for supporting the Chief Clinical and Provider Strategy Officer in managin...Show more
    Last updated: 30+ days ago • Promoted
    Sr. People & Culture Business Partner (Remote)

    Sr. People & Culture Business Partner (Remote)

    KLDiscovery • Eden Prairie, MN, United States
    Remote
    Full-time
    KLDiscovery offers a fantastic opportunity for you to use your talents to make a meaningful impact in a fast-paced, growing technology and services organization! KLDiscovery offers technology-enabl...Show more
    Last updated: 30+ days ago • Promoted
    Manager

    Manager

    American Multi-Cinema, Inc. • Coon Rapids, MN, United States
    Full-time
    As a Manager, you'll lead operations and people with purpose-supporting AMC's Mission while bringing our Values to life.You'll drive results through coaching, communication, and ownership, and help...Show more
    Last updated: 24 days ago • Promoted
    NIA DECC Communications Manager

    NIA DECC Communications Manager

    University of Minnesota • Minneapolis, MN, United States
    Full-time +1
    Job Family Marketing & Communications.Add to Favorite Jobs Email this Job.Priority Application Review Begins Monday, October 20, 2025. The Institute for Social Research and Data Innovation (ISRDI) i...Show more
    Last updated: 30+ days ago • Promoted
    Sr Mgr Product Strategy

    Sr Mgr Product Strategy

    Sun Country Airlines 2021 • Minneapolis, MN, US
    Full-time
    Senior Manager, Product Strategy.We're not your average airline.We're agile, resilient, and full of uncommon opportunity. Here, you can grow as part of an ambitious team that safely and collectively...Show more
    Last updated: 17 days ago • Promoted
    Sr. Manager - Marketplace Platform Strategy & Enablement Lead

    Sr. Manager - Marketplace Platform Strategy & Enablement Lead

    Best Buy • Minneapolis, MN, US
    Full-time
    Manager - Marketplace Platform Strategy & Enablement Lead.Manager - Marketplace Platform Strategy & Enablement Lead will be responsible for managing and delivering our strategic marketplace roadmap...Show more
    Last updated: 1 day ago • Promoted
    SVP Enterprise Strategy, UnitedHealth Group

    SVP Enterprise Strategy, UnitedHealth Group

    UnitedHealth Group • Eden Prairie, MN, United States
    Full-time
    UnitedHealth Group is a health care and well-being company that's dedicated to improving the health outcomes of millions around the world. We are comprised of two distinct and complementary business...Show more
    Last updated: 30+ days ago • Promoted
    Sr Communications Manager Executive Writer

    Sr Communications Manager Executive Writer

    Target • Minneapolis, Minnesota, USA
    Full-time
    Pay is based on several factors which vary based on include labor markets and in some instancesmay include education work experience and addition to your pay Target cares about and invests in you...Show more
    Last updated: 16 days ago • Promoted
    Sr. Manager Medicare Stars Program

    Sr. Manager Medicare Stars Program

    CVS Health • Minneapolis, MN, US
    Full-time
    At CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care.As the nation's leading h...Show more
    Last updated: 19 days ago • Promoted
    Sales Representative - Luxury Travel Incentives

    Sales Representative - Luxury Travel Incentives

    Platinum Supplemental Insurance • Coon Rapids, Minnesota
    Full-time
    Ready to jump-start your career and take charge of your earning potential?.At Platinum Supplemental Insurance, we’re looking for motivated individuals ready to learn, grow, and thrive in a fast-pac...Show more
    Last updated: 30+ days ago • Promoted
    Sr Director Global Professional Services & Strategies

    Sr Director Global Professional Services & Strategies

    Thermo Fisher • Minneapolis, MN, US
    Full-time
    Sr Director, Procurement Global Professional Services & Enterprise Strategies.When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work that makes a positive impact on a ...Show more
    Last updated: 6 days ago • Promoted
    Marketing & Comms Associate (Global Campaigns Strategy Analyst)

    Marketing & Comms Associate (Global Campaigns Strategy Analyst)

    Unisys Corporation • Hopkins, MN, United States
    Full-time
    What success looks like in this role : .The Global Campaigns Analyst is a critical position with a mission to support the end-to-end activation of our marquee programs and thought leadership campaign...Show more
    Last updated: 30+ days ago • Promoted
    Freelance Market Research Participant (Hiring Immediately)

    Freelance Market Research Participant (Hiring Immediately)

    Earn Haus • Andover, Minnesota, US
    Full-time +1
    We are urgently looking for people interested in taking online surveys for Fortune 500 brands.If you are a self-starter, looking for flexible hours throughout the week, this may be for you! Earn up...Show more
    Last updated: 30+ days ago • Promoted
    Director of Experiential and Partner-Based Mentoring

    Director of Experiential and Partner-Based Mentoring

    Big Brothers Big Sisters Of The Greater Twin Citie • Minneapolis, Minnesota, USA
    Full-time
    The Director of Experiential and Partner-Based Mentoring leads the vision design and delivery of BBBSTCs interest-based group and 1 : 1 mentoring programsincluding Free Arts and emerging enrichment i...Show more
    Last updated: 16 days ago • Promoted
    Food Service Director

    Food Service Director

    Aramark • Ramsey, MN, US
    Full-time
    Job Description The Food Service Director is a management position responsible for developing and executing dining solutions to meet customer needs and tastes. Oversees and manages dining operations...Show more
    Last updated: 2 days ago • Promoted
    Partners in Performance - Performance Strategy Senior Principal

    Partners in Performance - Performance Strategy Senior Principal

    Minnesota Staffing • Minneapolis, MN, US
    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: 1 hour ago • Promoted • New!
    Senior Manager, Clinical Strategy

    Senior Manager, Clinical Strategy

    bostonscientific • Maple Grove, Minnesota, USA
    Full-time
    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance.At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of d...Show more
    Last updated: 30+ days ago • Promoted
    Senior Manager, Communications & Community Relations

    Senior Manager, Communications & Community Relations

    Liberty Diversified International • New Hope, MN, United States
    Full-time
    Are you ready to lead the voice and communications vision of a company making an impact? As Senior Manager, Communications & Community Relations, you'll shape how our brand is seen, heard, and expe...Show more
    Last updated: 30+ days ago • Promoted