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Principal Medical Writer

Lausanne, Vaud, Switzerland · Clinical Research & Development

Description

Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For our Clinical Research & Development department based in Lausanne we are looking for a:

Principal Medical Writer

This position involves the development of study-related documents, communication with health authorities, publications and presentations. The Principal Medical Writer (PMW) ensures compliance with international guidelines and internal quality standards and is accountable for the process of authoring, reviewing and reconciliation of comments (following internal and external reviews), and finalisation/approval of documents.

The PMW is responsible for timely delivery of well-written concise documents that are supported by data and suited to the target audience and intended purpose.

Main responsibilities:

Writing:

• Writing regulatory documents in collaboration with the regulatory core team member and other internal functions: Investigational Medicinal Product Dossiers, Investigational New Drug Applications, Briefing Books, Orphan Drug Designation application, Fast Track and Breakthrough designation requests, Pediatric Investigational Plans (EU and US) etc.


• Writing protocols/amendments, informed consent forms (ICFs), clinical study reports (CSRs), Investigator's Brochures (IBs).


• Manage review cycles, reconciliation of comments, and finalisation/approval of these documents.


• Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements.

Collaboration and Interactions:

• Develop effective collaborations with other line functions.


• Interact with Medical Directors in order to contribute to the strategy and understanding the clinical aspect of the writing and priorities.


• Interact with Clinical Scientists in order to better understand the rational and to be provided with the right background material and ad hoc drafts of specific documents sections.


• Interact with Regulatory Affairs.


• Responsible for a timely document development and negotiating timelines with the Project/Study Team and the Medical Director.

Leadership:

• Provide leadership in cross-functional communication / team meetings to optimize feedback and input towards focused and high quality documents.


• Challenge and resolve conflict during document development and finalisation

• Drive process improvement and/or cross-functional initiatives (e.g., SOP review, template development).


• Develop the strategy for document preparation and the document review processes. Collaborate closely with the teams in order to better understand the needs, the planning, and timelines. Facilitate document review meetings and discussions.


• Collaborate with freelance and vendor medical writers and working across functional boundaries.

Strategy:

• Develop the strategy for document preparation and the document review processes. Collaborate closely with the teams in order to better understand the needs, the planning, and timelines. Facilitate document review meetings and discussions.

Resource Management:

• Participate in resource planning for medical writing deliverables.


• Prioritize and manage multiple demands and projects with respect to deadlines.

Quality:

• Understand and implement the applicable international quality standards (ICH GCP) and company procedures.


• Provide expert advice in the development and implementation of best practices in medical writing.

Requirements

Your profile:

• Minimum university life science degree or equivalent is required. Master’s degree in a scientific area is preferred.


• 7 years medical writing experience and/or other relevant pharma industry experience combined with the knowledge of drug development and regulatory requirements, plus extensive knowledge of medical writing processes.


• Proven experience in writing regulatory documents for FDA and EMA.


• Proven experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs.


• Experience in early phase clinical development in Oncology.


• In-depth knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.


• Good command of English and solid writing/editorial skills (understandable, at a level appropriate to the audience and the project).Solid writing/editorial skills in English. English Native speaker is an asset.


• Strong ability to prioritize and manage multiple demands and projects with respect to deadlines.


• Ability to communicate scientific or medical information in a clear and concise manner.


• Ability to interpret data, identify any limitations.


• Self-starter, flexible, able to adapt quickly in a fast-moving environment, work efficiently within the given time and resources.


• Ability to work with teams, establish trust, challenge appropriately and focus on results.


• Ability to lead and influence.

Debiopharm can offer you

• An international and highly dynamic environment, with a long term vision.


• A competitive compensation & benefit package.


• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.


• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.