- Location:
- Gaithersburg, MD 20878
- Status:
- Full Time, Employee
- Job Category:
- Biotech/R&D/Science
Principal Medical Writer I
Title: Principal Medical Writer I
Location: MD Gaithersburg - Corporate Headquarters
Req: 02041
Position Summary:
Major Duties and Responsibilities (including supervising others):
• Under minimal or no supervision writes and edits clinical study reports protocols informed consent forms and other clinical and regulatory documents including Investigator Brochures and annual reports.
• Leads the preparation of briefing documents INDs and other major submissions (BLAs MAAs) as needed.
• Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.
• Negotiates timeline development for preparation of clinical regulatory documents.
• Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).
• Reviews case report forms statistical analysis plans and data tables and listings for content and format.
• Assists in or leads the preparation or revision of SOPs WPDs and document templates.
• Participates in clinical project team meetings
• Participates in or leads other cross-functional team meetings and standards committees.
• Provides mentoring to junior writers.
• Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH GCP and other standards.
Experience:
• 6+ years experience writing clinical regulatory documents including clinical study reports.
• Pharmaceutical industry experience required.
• Background in biologics a plus.
Special Skills/Abilities:
• Experience writing and editing clinical regulatory documents.
• Ability to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
• Excellent writing editing attention to detail and verbal communication skills.
• Proficiency in Microsoft Word is essential.
• Familiarity with CTD ICH GCP and other standards.
• Ability to manage/prioritize multiple projects from conception to completion working in a fast-paced environment.
Job Complexity: Medium to high
Supervision: None to Low
(supervision required level of independence)
Educations:
Education:
• Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience.
CLICK HERE TO APPLY
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
Location: MD Gaithersburg - Corporate Headquarters
Req: 02041
Position Summary:
Major Duties and Responsibilities (including supervising others):
• Under minimal or no supervision writes and edits clinical study reports protocols informed consent forms and other clinical and regulatory documents including Investigator Brochures and annual reports.
• Leads the preparation of briefing documents INDs and other major submissions (BLAs MAAs) as needed.
• Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.
• Negotiates timeline development for preparation of clinical regulatory documents.
• Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).
• Reviews case report forms statistical analysis plans and data tables and listings for content and format.
• Assists in or leads the preparation or revision of SOPs WPDs and document templates.
• Participates in clinical project team meetings
• Participates in or leads other cross-functional team meetings and standards committees.
• Provides mentoring to junior writers.
• Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH GCP and other standards.
Experience:
• 6+ years experience writing clinical regulatory documents including clinical study reports.
• Pharmaceutical industry experience required.
• Background in biologics a plus.
Special Skills/Abilities:
• Experience writing and editing clinical regulatory documents.
• Ability to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
• Excellent writing editing attention to detail and verbal communication skills.
• Proficiency in Microsoft Word is essential.
• Familiarity with CTD ICH GCP and other standards.
• Ability to manage/prioritize multiple projects from conception to completion working in a fast-paced environment.
Job Complexity: Medium to high
Supervision: None to Low
(supervision required level of independence)
Educations:
Education:
• Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience.
CLICK HERE TO APPLY
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
