Syneos Health

Syneos Health

Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred

USA-NJ-Remote · Principal

Sponsorship not specified$95k-$211kDetected 6 days ago
StatisticsProject ManagementProcess ImprovementClinical TrialsClinical ResearchFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationTime Management

About the role

  • Reports to a Director of Medical Writing or above.

Responsibilities

  • Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and the client authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
  • Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
  • Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
  • Further, nothing contained herein should be construed to create an employment contract.
  • 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.
  • We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
  • 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 deliver - for one another, our customers, and, most importantly, for those in need.
  • We are committed to building an inclusive culture - where you can authentically be yourself.
  • Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.

Requirements

  • Proficiency in organizing and communicating clinical information required with minimal oversight.
  • Strong organizational, time management, and project management skills are required.
  • Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired.
  • Experience with an electronic document management system and templates is required.
  • Occasionally, required skills/experiences for jobs are expressed in brief terms.
  • Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work.
  • Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Nice to have

  • Bachelor's degree required.
  • Advanced degree in a relevant scientific/clinical/regulatory field preferred.

Compensation

  • $95,000.00 - $210,900.00
  • 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.
  • 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.

Benefits

  • Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred
  • Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
  • 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.
  • Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
  • Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
  • Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.

Company info

  • The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
  • The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
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This listing is sourced directly from Syneos Health's careers page and normalized into a canonical job model.