Medical Writer

Job description

The Medical Writer is a member of the Clinical Team. He/she is responsible for the production of key documents related to Clinical Department and Global Medical Affairs activities (e.g., concept documents, protocol, CSR, IBs, Informed Consent Forms, expert reports/integrated summaries, CTD Modules 2 and 5, etc.) in line with the Company as well as external standards, e.g., regulatory requirements or guidelines. For submissions (INDs/CTAs, eBLAs/CTDs etc), the Manager, Medical Writing can also play a key role in coordinating and overseeing the medical writers in the preparation of submission documents and the overall development of the submission.

The Medical Writer:

·  Is in charge of creating, writing, and coordinating concept documents, protocols, informed consent forms, and clinical study reports according to Sanofi Pasteur document standards, tools, and SOPs
·  Is in charge of creating, coordinating, compiling, and editing investigator brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) according to Sanofi Pasteur standards, tools, and SOPs.
·  Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards, coordinating the medical writing CTD activities (interaction with RA and other functions involved), and providing the CTD supportive activities within the medical writing department
·  Participates as a member of the clinical team accountable to the Clinical Team Leader for all project issues (role of referent medical writer)
·  Is involved in the peer-review and QC cross-check of documents produced by the Medical Writing platform and in the review of documents produced by other departments (such as SAP and CRF)
·  Contributes to the development of document templates and relevant SOPs. Represents the platform on committees and working groups within Clinical as requested
·  Provides mentoring support to less experienced colleagues and new Company staff members if needed
·  Provides project management of medical writing deliverables for a trial or project, including negotiating timelines, and identifying and escalating issues to both the clinical team and the local Head of Medical Writing
·  Is in charge of supervising subcontracted medical writing activities if needed.
·  May contribute to the updates of templates, SOPs, and other guides for Medical Writing

The Medical Writing platform is within Clinical Programs. The Medical Writer reports to the Local Head of Medical Writing for mentoring, appraisal and training. He/she may be the representative of his/her function in one or several clinical teams according to the number of projects he/she has to manage. In this case, he/she is accountable to the Clinical Team Leader for all project issues.

The Medical Writer is a member of one or more clinical teams according to the projects he/she has been assigned. His/her role is to be the referent for his/her function within the team. He/she will be responsible for coordinating the writing of major documents to conduct trials of the projects. He/she has to work in close collaboration with other functions/members of the clinical team to achieve the correct writing of documents.

Requirements:

Education/experience

·  BA/BS in Biology, Life Science, or related field of study, and at least 3 years of experience in pharmaceutical industry or equivalent; advanced scientific degree a plus
·  Fluent English communication skills, verbal and written
·  Demonstrated experience in clinical development, strong interpersonal, time management and technical writing skills

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SP           

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.