Senior Medical Writer 100% (f/m)
Ref#: TPIG - 0076
- Writes and/or edits clinical regulatory documents (generally clinical study protocols/amendments, clinical study reports, and Investigator’s Brochures and briefing documents)
- Ensures that these documents are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
- Prepares other documents for regulatory submissions
- Advises Clinical (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
- Ensures quality assurance of own documents
- Provides leadership/strategy at the cross-functional study-team level for individual documents
- Participates significantly in meetings at the document-team level
- Contributes to the preparation/revision of document templates, development of the process and preparation/revision of SOPs and guidance documents
- Works successfully in a cross-functional global team
- Communicates information clearly and concisely
- Preferred: Ph.D. in life sciences (or another related field) with a minimum of 2 years of experience related to medical writing or Masters in life sciences (or other related fields) with a minimum of 3 years of experience (or Bachelor’s degree with at least 5 years of relevant experience)
- Excellent English, both written and spoken
- Intermediate writing and editing skills and competence in the use of relevant software applications, and using templates, and other electronic formats
- Intermediate knowledge of government regulations pertaining to drug development and understanding of the Company’s products and standard operating
- procedures (SOPs)
- Ability to organize and present information and to communicate regulatory medical writing processes and technical and editorial standards
- Good organizational-, planning -and problem-solving skills at the document level
- Excellent presentation and written communication skills
- Works successfully with an intermittent level of direct supervision
- Interesting and challenging position with a market-based compensation package
Mepha Schweiz AG and Teva Pharmaceuticals International GmbH, as well as all related entities (in the following Mepha/Teva), do not accept any candidate submission from unsolicited third parties. Candidates presented by unsolicited third parties (such as recruitment agencies, headhunters etc.), will not be entered into the recruitment process and will not be considered further. Further on, no contractual relationship will result out of such a submission between Mepha/Teva and a third party. Mepha/Teva is not obligated nor willing to pay any fee to third parties submitting candidates in this manner.
Mepha Schweiz AG and Teva Pharmaceuticals International GmbH (the Group) are proud to be an equal opportunities employer. We are committed to providing equal access to employment opportunities to all prospective employees within the recruitment process. The Group complies with and supports all national and local laws pertaining to non-discrimination. Please note that the Group is supported by Serendi for Talent Acquisition Services. As their Recruitment Process Outsourcing provider Serendi is exclusively in charge of the above-mentioned position. Your data is handled according to the compliance guidelines of the Group. Please see the Recruitment Data Privacy Statement for more information. If you have any questions your recruiter will be happy to help. www.serendi.com
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