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Actalent

Actalent is hiring: Senior Medical Writer in Rockville

Actalent, Rockville, MD, United States, 20849

Actalent Senior Medical Writer - Rockville, Maryland

Independently write and lead the development of Clinical Study Reports (CSRs), including CSR Shells (Sections 1-9), Key Messages Map, and CSR Statistical Text (Results only - Sections 10, 11, and 12).

Closely interact with statisticians and other team members in the development of key messages map and CSR statistical text.

Drive the document preparation process, draft and distribute documents for review, and incorporate and resolve comments with all reviewers.

Hold comment resolution meetings, generate comment reports, and use quality control checklists during the document drafting process.

Participate in the review of CSR Statistical Text (if the statistician is drafting the text), CSR versions 0.1, 0.2, and 0.3 (and as needed), and CSR timelines.

Attend CSR kick-off meetings and other meetings as needed.

Experience and Skills Required:

  1. Experience with Clinical Study Reports (CSRs), including Tables, Figures, Listings (TFL), and early phase regulatory submissions.
  2. Ability to independently lead the development and writing of CSRs, taking TFLs from statisticians and advancing the material into a writing capacity.
  3. Understanding of regulatory requirements related to CSR sections.
  4. Experience with protocol reviews and infectious disease research.
  5. PhD or higher-level degree preferred.
  6. 4-5 years of experience as a Medical Writer with regulatory submissions and CSR development background.
  7. 1-2 years of experience if holding a PhD or higher-level degree.
  8. Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data.
  9. Understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, research methodology, regulatory environment including FDA/ICH guidelines, and principles of GXP/ICH/CTD.
  10. Ability to work collaboratively and coordinate the efforts of team members to resolve comments and produce a final high-quality document.
  11. Independently motivated with good problem-solving skills allowing analysis, synthesis, and compilation of data from a broad range of disciplines.
  12. Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines.
  13. Experience working in a fast-paced, cohesive, collaborative team-oriented work environment.
  14. Experience using Common Technical Document content templates.
  15. Expert knowledge of current electronic document management systems and information technology.

Work Environment:

This is a fully remote position. The team is small, with currently one Medical Writer and another taking leave. The role reports to the project lead and requires effective communication with the biostatistics team to take TFLs and create legible CSRs alongside a cross-functional team of statisticians.

Pay and Benefits:

The pay range for this position is $55.00 - $65.00. Benefits include:

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline:

This position will be accepting applications until Jan 16, 2025.

About Actalent:

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

Diversity, Equity & Inclusion:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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