122 days ago on sjobs.brassring.com

Senior/ Expert Medical Writer

Novartis Pharma Schweiz AG

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Senior/ Expert Medical Writer

Job ID 216506BR Position Title Senior/ Expert Medical Writer Division Global Drug Development Business Unit GDO GDD Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Senior Medical Writer: To write, edit and/or manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications.

Expert Medical Writer: To write, edit and manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative document-related expertise.

Main Accountabilities:

Senior Medical Writer:

1. Write/edit regulatory documents, such as Clinical Study Reports (CSRs), and contribute to Common Technical Document (CTD) summaries.

2. Participate in planning of analysis and data presentation to be used in study reports.

3. Act as a member of clinical trial teams following protocol finalization.

4. Act as project medical writer in clinical development and ensure medical writing resource within these programs.

5. Contribute to process improvement initiatives.

6. Training and mentoring of new associates as required.

Expert Medical Writer:

1. Act as a member of clinical trial teams and submission teams and autonomously write/edit Clinical Study Reports (CSRs), Common Technical Document (CTD) summaries and overview documents, and other regulatory documents.

2. Provide authoritative guidance to other line units with respect to regulatory submission documents and other document-related issues.

3. Act as lead writer for submissions and co-ordinate summary documents in collaboration with clinical team.

4. Write/edit other strategic documents, as required, in collaboration with project teams.

5. Participate in planning of analysis and data presentation in clinical programs, CSRs or summary documents.

6. Act as project medical writer for complex submission programs in clinical development.

7. Contribute to development of document templates and improvement initiatives.

8. Act as mentor for less experienced medical writers.
Minimum requirements Education:

Minimum university life science degree or equivalent. Higher degree desirable.

Language

Excellent written and spoken English.

Professional Experience:

Senior Medical Writer:

1. At least 3 years medical writing experience.

2. Good knowledge of statistics and data interpretation and presentation skills.

3. Good knowledge of clinical documentation.

4. Good knowledge of regulatory requirements.

5. Good knowledge of drug development.

Expert Medical Writer:

1. At least 4 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge, plus strong knowledge of medical writing processes.

2. Excellent data interpretation skills.

3. Expert knowledge of regulatory requirements and clinical development.

4. Excellent communication and presentation skills.

5. Good leadership skills within cross-functional teams.

6. Experience of coordinating writing activities for regulatory submissions.

7. Ability to mentor other medical writers.

8. Experience in process improvement initiatives.