Associate Director Medical Writer

Associate Director/Principal Medical Writer

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.

* MUST HAVE RECENT SUBMISSIONS WRITING EXPERIENCE*

and MUST be located on the East Coast of the United States

(this is remote but confirmation of current US/East Coast location is required)

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.

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 Organizations (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 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.
• In collaboration with ITS, lead transversal project teams in view of the implementation of new technologies for accelerating the preparation of the documents and providing cost saving.

About You

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, possessing 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.
• Keen interest in exploring and implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions.
• Native English speaker or with proven excellent spoken and written English.
• Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills.

Formal Education And/or Experience required

• 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.

Knowledge and skill desirable but non-essential

• Specific knowledge of company-targeted therapeutic areas is strongly desirable.