Medical Writer at Glenmark Pharmaceuticals Inc

Job Details

Job Type

Contract

Full Job Description

POSITION DESCRIPTION
Role / Position Title – Medical Writer
Department/Function – Innovative Regulatory Affairs
Country – USA
Region / City (within Country) – Mahwah, NJ
FLSA (Exempt/Non-Exempt) – **This is a contract role**
Hours – 8 a.m. to 5 p.m. in office 3-5 days per week

OVERALL JOB RESPONSIBILITIES
Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Write and/or review regulatory submission documents such as Clinical Study Reports (CSRs), protocols, Investigator’s brochures (IBs), safety narratives.
• Write and/or review clinical modules such as clinical overview (2.5) and summaries (2.7), Briefing books, and Meeting Request (MR) document.
• Prepare clinical trial disclosures and registration datasets for ClinicalTrials.gov, EudraCT, and CTRI registries and gain internal/registry approvals; manage clinical trial disclosure desk enquiries.
• Prepare CSRs and drive the process by conducting or ensuring the following activities are completed:
• Identify contributors and their responsibilities.
• Develop and maintain timelines in collaboration with clinical team.
• Lead kick-off meetings, results review meetings, and comments resolution meetings.
• Prepare final CSRs, manage review cycles, and resolve and incorporate comments appropriately.
• Manage QC and compilation of report appendices.

• Contribute to development of document templates/SOPs.
• Thorough understanding of and experience in US-FDA and EMEA requirements related to regulatory medical writing activities.
• Maintain audit, SOP, and training compliance.
• Leadership / Managerial Attributes – work closely with the global medical writing team and management and engage with process improvement, cross-functional team engagement, successful delivery of documents to agreed timelines and with high quality.

KNOWLEDGE, SKILLS, AND ABILITIES
Education

• MD/ PhD or Relevant Master’s degree in life sciences, e.g., pharmacology

Experience

• 5-7 years of medical writing experience gained in a pharmaceutical or CRO environment specifically for US FDA/ EMEA

Knowledge and Skills (Functional / Technical)

• Excellent understanding of clinical trial methodology, study designs, and statistical approach/analysis used in medical writing.
• Fluent written and spoken English language.

Physical demands and abilities

• The incumbent typically works in an office environment and uses a computer, telephone, and other office equipment as needed to perform duties.
• The noise level in the work environment is typical of that of an office.
• Incumbent may encounter frequent interruptions throughout the work day.
• The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds.

Glenmark Pharmaceuticals Inc USA is proud to be an equal-opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.