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 LLCMarshfield, WI, United States
job_description.job_card.variable_hours_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 • Marshfield, WI, United States

    Job_description.internal_linking.related_jobs
    Service-Writer

    Service-Writer

    MediabistroMarshfield, WI, United States
    serp_jobs.job_card.full_time
    Ascendance Truck Centers is one of the region's premier Commercial Truck Sales & Leasing Dealerships.Our team enjoys a fantastic culture and opportunities for advancement, which are company-wide fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Medical Assistant, Certified

    Medical Assistant, Certified

    Family Health Center of Marshfield IncMarshfield, WI, US
    serp_jobs.job_card.full_time
    The Certified Medical Assistant – Family Health Center (FHC) functions as a vital member of the healthcare team who contributes to the success by demonstrating patient focus, effective commun...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Emergency Medicine Physician

    Emergency Medicine Physician

    ProLocumsNeillsville, WI, US
    serp_jobs.job_card.full_time
    Specialty : Emergency Medicine.Note the first day would need to be designated for orientation and ideally that would be on 12 / 22. Hospitalist available 8a-4p 7 days / week.The EM is responsible for th...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel PICU Registered Nurse - $2,487 per week

    Travel PICU Registered Nurse - $2,487 per week

    Premier Medical Staffing ServicesMarshfield, WI, United States
    serp_jobs.job_card.permanent
    Premier Medical Staffing Services is seeking a travel nurse RN PICU - Pediatric Intensive Care for a travel nursing job in Marshfield, Wisconsin. Job Description & Requirements.PICU - Pediatric Inte...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Physician / Emergency Medicine / Wisconsin / Locum Tenens / Locums Emergency Medicine Job in Wisconsin Job

    Physician / Emergency Medicine / Wisconsin / Locum Tenens / Locums Emergency Medicine Job in Wisconsin Job

    MD Staff, LLCAbbotsford, WI, United States
    serp_jobs.job_card.full_time
    Locum Tenens Emergency Medicine Physician Opportunity Near Abbotsford, WI.We are seeking a dedicated Emergency Medicine physician for a locum tenens opportunity near Abbotsford, WI.This position is...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Health Information Specialist I

    Health Information Specialist I

    DatavantMarshfield, WI, US
    serp_jobs.job_card.full_time
    Datavant is a data platform company and the world's leader in health data exchange.Our vision is that every healthcare decision is powered by the right data, at the right time, in the right for...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Director

    Medical Director

    Theoria MedicalOwen, WI, US
    serp_jobs.job_card.full_time
    Leading the charge in healthcare innovation, Theoria Medical offers a unique blend of medical excellence and technological advancement, primarily serving the post-acute and primary care sectors.Our...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Medical Corps Officer

    Medical Corps Officer

    US Navy ReserveNeillsville, WI, US
    serp_jobs.job_card.part_time +1
    ABOUT Serve your country as a part-time physician.This position DOES NOT require you to relocate.Navy commissioned physicians attend to service members and their families in much the same way a civ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine in Marshfield, WI

    Locum Physician (MD / DO) - Emergency Medicine in Marshfield, WI

    LocumJobsOnlineMarshfield, WI, US
    serp_jobs.job_card.full_time +1
    LocumJobsOnline is working with CompHealth to find a qualified Emergency Medicine MD in Marshfield, Wisconsin, 54449!.Though your CompHealth recruiter will be your single point of contact, they are...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Adolescent Medicine Specialist to Join Pediatric Multispecialty Practice in Heart of Wisconsin

    Adolescent Medicine Specialist to Join Pediatric Multispecialty Practice in Heart of Wisconsin

    Marshfield Clinic Health SystemMarshfield, WI, United States
    serp_jobs.job_card.full_time
    BC / BE fellowship-trained Adolescent Medicine.This fellowship-trained / Board Eligible Physician will be integral in caring for the special needs of teenagers and young adults, treating a variety of a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Physician / Emergency Medicine / Wisconsin / Locum tenens / Locums Emergency Medicine Job in Wiscons

    Physician / Emergency Medicine / Wisconsin / Locum tenens / Locums Emergency Medicine Job in Wiscons

    Hayman Daugherty Associates, IncOwen, WI, US
    serp_jobs.job_card.full_time
    Locum Tenens Emergency Medicine Physician Needed ASAP - Ongoing (Near Owen, WI) (j-233279).Are you a board-certified emergency medicine physician seeking a rewarding locum tenens opportunity?.Join ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Part Time Medical Director Owen, Wisconsin

    Part Time Medical Director Owen, Wisconsin

    Theoria MedicalOwen, WI, United States
    serp_jobs.job_card.full_time +1
    Up to $200,000 annually + monthly Medical Director Stipend.Competitive compensation with balanced hours.NP / PA support at all locations, always. Pre-Screened Patient Interactions.Virtual care team an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Physician / Emergency Medicine / Wisconsin / Permanent / EM Physician in Wisconsin Job

    Physician / Emergency Medicine / Wisconsin / Permanent / EM Physician in Wisconsin Job

    MD Staff, LLCGreenwood, WI, United States
    serp_jobs.job_card.full_time +1
    Exciting Permanent Opportunity for Emergency Medicine Physician in Greenwood, WI.Are you an experienced and compassionate Emergency Medicine Physician seeking a fulfilling and permanent career oppo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Emergency Medicine - Medford, Wisconsin

    Emergency Medicine - Medford, Wisconsin

    Aspirus HealthMedford, WI, United States
    serp_jobs.job_card.full_time +1
    Aspirus Health is seeking an Emergency Medicine physician to .Use the full scope of your training and work with a great team! . Full and part-time opportunities available.Advanced Practice Clinician...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Pediatric - Adolescent Medicine Physician

    Pediatric - Adolescent Medicine Physician

    Marshfield Clinic Health SystemMarshfield, WI, US
    serp_jobs.job_card.full_time
    BC / BE fellowship-trained Adolescent Medicine.This fellowship-trained / Board Eligible Physician will be integral in caring for the special needs of teenagers and young adults, treating a variety of a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Locum | Physician Emergency Medicine

    Locum | Physician Emergency Medicine

    CompHealthMarshfield, WI, United States
    serp_jobs.job_card.full_time
    Though your CompHealth recruiter will be your single point of contact, they are backed by dozens of specialized teams, giving them the ability to focus on the details that matter to you.That means ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Physician / Emergency Medicine / Wisconsin / Locum tenens / Locums Emergency Medicine Job in Wisconsin Job

    Physician / Emergency Medicine / Wisconsin / Locum tenens / Locums Emergency Medicine Job in Wisconsin Job

    Hayman Daugherty Associates, IncOwen, WI, United States
    serp_jobs.job_card.full_time
    Locum Tenens Emergency Medicine Physician Needed ASAP - Ongoing (Near Owen, WI) (j-233279) Are you a board-certified emergency medicine physician seeking a rewarding locum tenens opportunity? Join ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Physician / Emergency Medicine / Wisconsin / Permanent / EM Physician in Wisconsin Job

    Physician / Emergency Medicine / Wisconsin / Permanent / EM Physician in Wisconsin Job

    Hayman Daugherty Associates, IncGreenwood, WI, US
    serp_jobs.job_card.permanent
    Exciting Permanent Opportunity for Emergency Medicine Physician in Greenwood, WI.Are you an experienced and compassionate Emergency Medicine Physician seeking a fulfilling and permanent career oppo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Physician / Pathology / Wisconsin / Locum Tenens / Anatomic & Clinical Pathologist Job

    Physician / Pathology / Wisconsin / Locum Tenens / Anatomic & Clinical Pathologist Job

    Adelphi Staffing, LLCMarshfield, WI, US
    serp_jobs.job_card.full_time
    Specialty : Anatomic and Clinical Pathology.Facility Location : Marshfield, WI.Reason For Coverage : Supplemental.Coverage Period : Jan 5, 2026 - Ongoing. Coverage Type : Clinical + Call.Call Schedule : -...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Locum Physician (MD / DO) - Emergency Medicine in Marshfield, WI

    Locum Physician (MD / DO) - Emergency Medicine in Marshfield, WI

    LocumJobsNetworkMarshfield, WI, US
    serp_jobs.job_card.full_time +1
    LocumJobsNetwork is working with CompHealth to find a qualified Emergency Medicine MD in Marshfield, Wisconsin, 54449!.Though your CompHealth recruiter will be your single point of contact, they ar...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days