Sanofi Group Principal Medical Writer in Cambridge, Massachusetts
The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead.
As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole and individual clinical studies.
More specifically the position holder:
Is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide. This work involves close cooperation with members of the CTT and Project Team, as well as colleagues within Clinical Documentation.
Must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Therapeutic Department Head, is presented accurately and concisely.
May need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff(e.g. for the preparation of tables, illustrations and appendices).
In addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for the mentoringand/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and the coordination of external contractors.
In addition, he/she is the Clinical Documentation representative in transversal initiatives to contribute to the implementation of process improvement and development of innovative solutions and technologies to bring efficiencies and cost savings.
He contributes to training preparation and delivery, and provides support to the medical writing teams.
Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified.
Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications.
Experience as Lead Project MW on multiple types of clinical documents.
Professional background documenting an excellent understanding of, and experience
in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment.
Specific knowledge of company-targeted therapeutic areas is strongly desirable.
Knowledge and Skills:
An experience as a Medical writer of at least 6 years, or equivalent.
Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English.
Excellent interpersonal and leadership skills.
Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment.
Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail.
Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills.
Native English speaker or with proven excellent spoken and written English.
Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills.
Major Duties and Responsibilities:
Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications.
Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies.
Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains.
Prepare, or coordinate the preparation of, clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package.
Prepare, or coordinate the preparation of, responses regarding company drug submission dossiers to Health Authorities.
Review and edit work of contract writers to ensure quality is maintained.
Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations.
Maintain awareness of current clinical documentation requirements for target regulatory agencies.Notify management of any changes to standards and the impact of these changes on systems/processes.
Represent Clinical Documentation as Subject Matter Expert on transversal initiatives concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving.
Acts as change agent for the medical writing teams.
Share experience with and train other medical writers.
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.
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.