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| Associate Director Medical Writing |
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Manages internal Medical Writing staff and Medical Writing vendors. Writes and/or reviews a variety of clinical documents (i.e., protocols, reports, summaries, investigator brochures). Ensures that the medical writing tasks are performed in a timely and efficient way, and are consistent with agreed procedures. Responsible for the management of medical writing deliverables for clinical trials run by the Research & Development Organization.
KEY TASKS & RESPONSIBILITIES
Recruit, train, develop and motivate local Medical Writing staff
Define staff objectives and evaluate performance
Manage Medical Writing activities for clinical trials run by the R&D Organization
Selects Medical Writing vendor according to R&D outsourcing strategy and in close collaboration with Corporate External Services
With manager, review trial and project progress and ensure that appropriate resources are available and that work is delivered on time
Collaborate with manager to ensure consistency and harmonization of work and deliverables across trials
Ensure compliance with regulations, guidelines, and quality standards
Handle internal medical writing quality audits
Contribute to the continuous improvement and implementation of processes
Ensure the delivery of high quality, timely clinical documents, including Clinical Trial Reports, IBs, Clinical Trial Protocols and contribute to submission plans
Write and/or review reports and regulatory submission documents
Contribute to preparation of Investigator Brochures
Attend appropriate Trial Team and Clinical Development Team meetings and assume team responsibilities
Write and/or review protocols, amendments, review statistical analysis plans. Ensure appropriate incorporation into reports
Other duties as assigned |
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Bachelors Degree (BS or higher degree in a scientific discipline or health related field)
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10 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Geneva |
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BS or higher degree in a scientific discipline or health related field
Experience with Medical Writing for Ph. I-IV trials as well as global regulatory submissions
Management or supervisory experience
English
Must be highly motivated, able to work independently, and willing to accept and assume leadership role
Ability to mentor and train others
Strong project management skills, detail orientation, and ability to organize and prioritize simultaneous projects required
Able to work well with all levels of staff, both European and US, in fast-paced, challenging environment
Excellent oral and written communication skills
Good knowledge of clinical drug development processes and relevant clinical terminology
Profound knowledge of ICH/GCP, FDA as well as international regulatory requirements
Ability to operate in a multi-cultural atmosphere
Ability to coordinate experts
Extensive knowledge and experience in collaboration and supervision of contract research organizations
Excellent computing skills (MS-Office standard software package, preferably experience with document-management-systems) |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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