Principal Medical Writer – Regulatory Focus

Medical writerMedical writerFull TimeRemoteLeadTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Poland

Posted

6 days ago

Salary

0

Seniority

Lead

Bachelor Degree5 yrs expEnglish

Job Description

Principal Medical Writer – Regulatory Focus

Syneos Health

• The Principal Medical Writer I is responsible for the development of clinical documents for submissions to regulatory authorities globally. • Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents accurately and consistently present key data-driven clinical messages. • Writes or provides direction and leadership to other writers to ensure the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. • Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. • Manage medical writing projects, including developing timelines and communication with cross-functional team members to maintain awareness of review cycles and expectations. • Review other documents associated with the assigned project(s) as appropriate. • Participate in cross-functional process improvement initiatives.

Job Requirements

  • Bachelor's degree required.
  • Advanced degree in a relevant scientific/clinical/regulatory field preferred.
  • At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
  • Proficiency in organizing and communicating clinical information required with minimal oversight.
  • Strong organizational, time management, and project management skills are required.
  • Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
  • Proficient understanding and knowledge of global regulatory requirements needed.

Benefits

  • 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 building an inclusive culture – where you can authentically be yourself.

Related Categories

Related Job Pages

More Medical writer Jobs

Full TimeRemoteTeam 10,001+H1B No Sponsor

• The Medical Writer supports client engagements and internal requests, projects, and business development efforts by doing the necessary research, data collection, analysis, and interpretation. • Development of value messages, dossiers, reports and other written deliverables, modeling, educational materials. • Conducting stakeholder and market access research; working with programming and design; and presenting to clients as needed. • Draft content in line with the outline/approach required, in an appropriate style for the deliverable. • Accurate markup references and implementation of directive changes with minimal supervision.

India
Job Closed
Full TimeRemoteTeam 10,001+Since 1956H1B Sponsor

• Serve as primary author for routine documents like clinical study reports and study protocols. • Summarize data from clinical studies. • Assist with more complex clinical and scientific documents. • Ensure compliance with quality processes and requirements. • Assist in program management activities, including timelines, budgets, and forecasts. • Represent the department at project launch and review meetings.

Netherlands
AdventHealth logo

Clinical Documentation Auditor

AdventHealth

AdventHealth is on a Christian mission to “extend the healing ministry of Christ” by focusing on whole-body restoration and wellness. Led by President and C

Medical writer6 days ago

Title: Clinical Documentation Auditor Location: La Grange, IL, USA Job Description: Part time job requisition id R-0352626 Our promise to you: Joining UChicago Medicine AdventHealth is about being part of something bigger. It’s about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. UChicago Medicine AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better. All the benefits and perks you need for you and your family: - Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance - Paid Time Off from Day One - 403-B Retirement Plan - 4 Weeks 100% Paid Parental Leave - Career Development - Whole Person Well-being Resources - Mental Health Resources and Support - Pet Benefits Schedule: Part time Shift: Day (United States of America) Address: 5101 WILLOW SPRINGS RD City: LA GRANGE State: Illinois Postal Code: 60525 Job Description: - Schedule: Part Time, 24 hours/week; flexible scheduling within standard business hours - Remote role but candidate must be local to area. Must be available for in-person meetings every other month and in-person training/education as needed Completes accurate and timely record reviews to ensure the integrity of documentation compliance. Inputs data accurately and concisely into CDI Software. Reviews concurrent and retrospective medical records for documentation compliance, including completeness and accuracy for SOI, ROM, and quality. Supports CDI documentation strategies and educates self and team members through monthly mandated education sessions and provided educational tools. Conducts quality audits, including deceased second-level reviews, focused disease process reviews, patient safety indicators, and CDI team audits. Collects, analyzes, and reports data to the CDI Leadership team. Recognizes opportunities for documentation improvement using strong critical-thinking skills. Uses critical thinking and sound judgment in decision-making, balancing quality considerations with regulatory compliance. Educates patient-care team members on documentation regulations and guidelines, including quarterly and annual compliance updates from Medicare. Initiates and formulates CDI severity worksheets and clinically credible clarifications for inpatients. Presents opportunities for improved documentation compliance to physicians, nurse practitioners, and other clinical team members. Transcribes documentation clarifications as appropriate for SOI, ROM, PSI, HCCs, and HACs. Other duties as assigned. Knowledge, Skills, and Abilities: • Excellent interpersonal skills including excellent verbal and written communication skills; proficient in and demonstrates excellent physician relations. [Required] • Able to organize and present information clearly and concisely. [Required] • Excellent computer and keyboarding skills; ability to use multiple software programs simultaneously; high degree of prioritization skills. [Required] • Ability to learn/develop and fine-tune the skills necessary to perform optimally as a Clinical Documentation Specialist. [Required] • Dependable, self-motivated, and pleasant. [Required] • Utilize and demonstrate excellent critical-thinking, problem-solving and deductive-reasoning skills. [Required] • Knowledge of pathophysiology, disease processes and treatments. [Required] • Strong ability to organize/triage work and manage multiple priorities at once. [Required] • Knowledge of quality guidelines. [Required] • Knowledge of clinical documentation requirements that identify clinical conditions or procedures. [Preferred] • Coding background. [Preferred] Education: • Associates [Required] • Master's [Preferred] Field of Study: • of Science in Nursing and 3 years of Clinical Documentation Integrity Specialist experience OR 4 years of recent Clinical Documentation Specialist experience • of Science in Nursing • or higher degree in a healthcare related field Work Experience: • 1+ of second level review CDIS experience • 4+ of recent clinical documentation specialist experience [Required] • 4+ acute care nursing experience with specific medical/surgical, intensive care, post-acute care unit, or emergency department experience [Required] • 5+ CDI experience Licenses and Certifications: • Certified Billing and Coding Specialist (CBCS) [Required) * Registered Nurse (RN) [Required] OR Physician Assistant (PA) [Required] OR Certified Registered Nurse Practitioner (CRNP) [Required] OR Advanced Practice Registered Nurse (APRN) [Required] OR Medical Doctor (MD) [Required] OR Doctor of Osteopathic Medicine (DO) [Required] OR Educational Commission for Foreign Medical Graduates (ECFMG) [Required] Pay Range: $71,588.85 - $133,150.39 This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.

Illinois
$71.6K - $133.2K / year
Full TimeRemoteTeam 10,001+Since 1990H1B No Sponsor

• Lead the development of high-quality regulatory and clinical documents • Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations • Prepare and review clinical study reports, protocols, and regulatory documents for accuracy and clarity • Collaborate with cross-functional teams to gather and synthesize information for document development • Provide guidance on medical writing best practices and ensure adherence to regulatory requirements • Mentor and train junior medical writers, fostering a culture of excellence and professional growth • Stay current with industry trends and regulatory guidelines

United Kingdom