Clinical Development Specialist

2 weeks ago


Pune, Maharashtra, India Lifelancer Full time

About Lifelancer:

Lifelancer is a leading talent-hiring platform for Life Sciences, Pharma and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

We're actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring swift delivery of life-changing ideas and therapies to patients in need.

As a collaborative workspace where personal growth is nurtured, we enable our team members to make a meaningful global impact.

About the Role:

Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.

Ensure compliance of operations with governing regulatory requirements.

Create, maintain and assume accountability for a culture of high customer service.

Efficiency in conducting literature searches for authoring various types of reports.

Author/review various safety reports (or part of such reports) for global regulatory submissions for clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.

Perform/review Signal detection activities.

Author/ review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports.

Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs.

Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting/justification document.

Author/review SOPs/WIs/process documents or sections as applicable.

Impart/conduct Trainings for peers and team members.

What You Will Need:

  • A bachelor's degree in a related field.
  • 5+ years of experience in clinical research and development.
  • Possess strong analytical and problem-solving skills.
  • Excellent communication and writing skills.
  • Ability to work effectively in a team environment.
  • Familiarity with industry-standard software and tools.

Compensation Package:

The estimated annual salary for this role is $120,000-$160,000 based on industry standards and location.

Lifelancer offers a competitive compensation package that includes benefits and opportunities for professional growth and development.



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