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Pharmaceutical Content Specialist

1 month ago

Pune, Maharashtra, India Lifelancer Full time

About the Job

Located in Hinjewadi Phase 3, Pune, we are seeking a skilled Pharmaceutical Content Specialist to join our team.

Qualifications:

  • B-Pharm or M-Pharm degree
  • Clinical experience in the research field

Note: Bioequivalence and bio-availability studies (BA/BE) are mandatory for this role.

Job Description

We are looking for an experienced Medical Writer with expertise in preparing regulatory submissions for various regulatory authorities including DCGI, USFDA, EMA, ANVISA, CDSCO, TGA, and CANADA. Key responsibilities include:

  1. Preparing BA/BE study protocols in compliance with ICH-GCP regulations.
  2. Creating clinical trial protocols for Phase III and Phase IV studies.
  3. Developing investigator brochures.
  4. Preparing feasibility and study synopses.
  5. Creating informed consent forms (ICF) and case report forms (CRF).
  6. Preparing protocol amendments and amendment reports.

The ideal candidate will have strong knowledge of clinical research and pharmaceutical regulations. Experience in reviewing outsourced BA/BE study protocols and CSR documents is also essential.

Lifelancer is a talent-hiring platform connecting professionals in Life Sciences, Pharma, and IT. If you're passionate about creating high-quality content, we encourage you to apply.