Senior Regulatory Writer Job in New Jersey (NJ), Research and Development Career, Full Time Jobs in Novartis Pharmaceuticals
Sign in
Create a candidate account
Create a candidate account
Create an employer account
Sign in to an existing account
Create a candidate account
Create an employer account
Sign in to an existing account
Forgot password
Forgot password
Sign in
Create a candidate account
Sign in
Create an employer account


Senior Regulatory Writer job in East Hanover

Sign in
Create a candidate account
Novartis Pharmaceuticals jobs
New Jersey (NJ), East Hanover
Job Code:  243238BR
Employer:  Novartis Pharmaceuticals
Category:  Research and Development
Job Type:  Full Time

Country:  United States
State:  New Jersey (NJ)
City:  East Hanover

The Sr. Regulatory Writer will write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. The Sr. Regulatory Writer will also provide documentation related consultancy to other line functions and may coach, mentor and/or train less experienced writers.

Major Responsibilities:

1. To author, review and manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission documents (e.g., summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics).

2. Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team.

3. Major contributor to planning of data analyses and presentation used in CSRs and submission documents.

4. Documentation specialist in CTTs and Clinical Submission Teams (CST) to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide content expertise and guidance for clinical portions of the CTD.

5. Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents. Extended member of International Clinical Team (ICT)

6. Lead Writer for simple submissions, contributing to key messaging and pooling strategy, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.

7. Contribute to process improvement in RWS and/or cross-functional initiatives or activities.

8. Coach and/or mentor less experienced writers.

9. Leader in cross-functional communication to optimize feedback and input towards high quality documents.

10.Maintain audit, SOP and training compliance.EDUCATION: University life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.

Language: Fluent English (oral and written)


• ≥ 4 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes

• Advanced knowledge of and experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements)

• Advanced knowledge of and repeat experience in global registration of drugs (complex submissions)

• Excellent communication skills (written, verbal, presentations)

• Advanced knowledge of biostatistics principles

• Strong ability to prioritize and manage multiple demands and projects

• Ability to define and solve complex problems

• Broad knowledge and future oriented perspective

• Ability to drive and manage organizational and team performance across cultures

.• Proven track record in matrix environment

• Some experience in managing global, cross-functional teams or simple global projects
ref: (243238BR)
Back to search results

Popular locations: New Jersey (NJ) (519) | Maryland (MD) (445) | Pennsylvania (PA) (175) | Texas (TX) (173) | California (CA) (119) | Massachusetts (MA) (108) | North Carolina (NC) (107) | Delaware (DE) (102) | Indiana (IN) (67) | Ohio (OH) (30)

Popular categories: Research and Development (518) | Sales (288) | Operations (144) | Clinical Research (138) | Information Technology (101) | Sales and Marketing (96) | Other (95) | Laboratory (92) | Other (85) | Business Development (83)

Popular jobs: Manager (489) | Sales (397) | Director (386) | Associate Director (154) | Account Manager (134) | Business Development (91) | Project Management (77) | Senior Specialist (39) | Bioinformatics Scientist (29) | Account: Ophthalmics Sales Territory Manager (22)