Associate Director-Principal Medical Writer

Job Title: Associate Director-Principal Medical Writer

Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

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.

Our Team:

Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

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 mentoring and/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. He /she leads projects in view of developing innovative solutions and technologies (e.g. content re-use, AI) to bring efficiencies and cost savings.

He/she contributes to training preparation and delivery, and provides support to the medical writing teams.

Principal 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 doc