Director - Medical Writing - Astellas - Northbrook

Job description
Purpose & Scope of Position:
Provide effective management oversight for Medical Writing roles (generally Global Medical Writing Lead [GMWRL] Levels
III and IV, Document Working Group Facilitator [DWGF], Quality Control [QC], and Administrator of Standards and Format
[ASF]) across all phases of development and both individual and summary document levels. Scope includes participation
in organizational strategy, definition and maintenance of writing or QC standards and process.

Essential Job Responsibilities:
Strategy
* Participates in development of 1 -- 3 year medical writing-specific objectives and plans.
* Develops and implements plans to achieve objectives.
* Assists the functional head in the integration of the departmental mission with that of GDO and APGD.

* Collaborates with other function(s) within GDO in order to ensure integrated and consistent GDO approaches.
* Provides oversight of the budget for functional area, maintains awareness of budget status, and contributes to the
management of the entire Medical Writing budget in line with agreed targets, as well as collaborates with other GDO
function(s) regarding management of project costs and cost-saving strategies.

People Management and Development

* Direct supervision of 5 -- 10 individuals.
* Responsible for recruitment, development / career management and retention of staff.
* Coaches, develops and supports Medical Writing in providing best in class medical writing management support to
Astellas drug development programs, and in effectively collaborating with other departments (internal and external)
assigned to the project; generally mentoring/coaching Levels III and IV GMWRL, collaborations within a global project
team, NDA/MAA oversight group and/or other functions within Astellas, and through CRO partnering strategies and
assessments.
* Provides oversight and guidance to others in completing all types of medical writing deliverables (e.g., NDA/MAA and
IND/IMPD dossiers, complex briefing documents and responses to regulatory agencies) according to agreed timelines
following quality standards.
* Sufficiently understands the industry perspective and corporate needs to develop and implement appropriate training
programs, in collaboration with Functional Head and/or other GDO function(s), by utilizing trend analyses and data
provided by less senior Line Management.

Performance and Resource Management

* Provides timely and accurate updates to Global Development Operations (GDO) leadership to enable successful
functional support of projects.
* Provides oversight of the departmental management and allocation of internal and external resources to projects.
* Collaborates with internal and external stakeholders to ensure appropriate departmental monitoring and management
of performance standards. Ensures consistency of departmental mentoring and coaching and, through collaboration
with Functional Head and other function(s) within GDO, ensures integrated and consistent GDO approaches.
* Oversees adherence to timelines, standards, processes for work assigned to the department. Collaborates with Line
Management of other functions within GDO in order to ensure integrated and consistent GDO approaches.
* Contributes to the development and implementation of quality programs; generally evaluating and implementing
recommendations for improvement within the department and supporting GDO.
* Reviews availability of sufficiently qualified vendor resources on a regular basis, contribute to planning of future vendor
resource needs; generally through departmental resource reviews, CRO alliance and partner assessment strategies, including functional service provider forecasts.
* May spend up to 25% of time (Level III) or up to 30% of time (Level IV) in departmental resource review and
metrics/performance analyses and/or other departmental activities.
* Oversight of training program of vendor staff in Astellas standards, processes, and systems; generally through CRO
alliance building and partner assessment strategies.
* Oversight of vendors and management of metrics system such that deliverables are available on time according to
Astellas standards and quality requirements; generally through departmental reviews and CRO partner assessment
activities.

Quality oversight

Oversees adherence to quality standards: for work assigned to direct reports or CRO and assessment of quality metrics.
Through support of departmental quality efforts (e.g., QC infrastructure, quality/compliance review of
documents).
Through interactions with CRO project manager and CRO governance
Through CRO alliance building and partner assessment strategies.
Develops and implements quality standards and process improvements through utilization of data and evaluations
provided by less senior Line Management. Collaborates with other GDO function(s) to provide quality oversight (Level
IV).
Responsible for compliance of direct reports with Astellas policies and procedures.

Technical Excellence

* Technical skill with respect to techniques of scientific writing and editing (e.g., as defined by Drug Information
Association [DIA] Medical Writing Competency Model) sufficient to enable mentoring and coaching of individuals within
the department or others performing Medical Writing functions.
* Identifies development opportunities for direct reports, other members of the department, and collaborates with
Functional Head and/or other functions to improve development opportunities for GDO.
* Participation in professional societies and groups (e.g., DIA Special Interest Area Community, SIAC) in order to ensure
that Astellas Medical Writing function is state of the art.

Process Development

Contributes to improvement efforts, implements agreed improvement actions and monitors effects after
implementation. May lead improvement efforts with respect to departmental quality document and process standards
in addition to management, mentoring and coaching activities.
Contributes to development and implementation of best in class standards, processes and SOPs in medical writing;
generally, may lead or collaborate in a multidiscipline productivity or process initiative.
Drives efforts to ensure processes remain aligned with best practices and corporate needs.
Collaborates with Line Management of other functions within Global Development Operations in order to
ensure integrated and consistent GDO approaches.
Leads strategic improvement projects.

Quantitative Dimensions.

* Conveys positive messages and representation of Medical Writing with Astellas teams and CROs as well as in
interactions in professional societies.
* Contributes to the quality and performance of CROs and staff, impacting costs and success of multiple programs.
Directly or indirectly responsible for oversight of Medical Writing activities, through CRO alliances and
performance management, with budgets up to $4-6M/year per program.
* Responsible for hiring and firing.

Organizational context.
* Manages 5-10 direct reports. Generally manages Project Program track Global Medical Writing Lead (GMWRL) Level III but may also
manage GMWRL Levels I-II, Document Working Group Facilitator (DWGF); Quality Control (QC); and/or
Administrator of Standards and Format (ASF) tracks when necessary.

REQUIRED

* BA/BS or equivalent with 10+ years relevant experience.

PREFERRED
PhD/Pharm D or MS/MA/MPH with 10+ years experience as a writing, regulatory or quality
professional in the pharmaceutical industry, at least 5 years experience in activities associated with the
management of regulated documents in the pharmaceutical industry, and has led/substantially participated in
the Medical Writing effort for at least 2 dossiers (NDA/MAA) or has evidence of an equivalent knowledge
base.

* Activities require advanced information gathering and conceptual skills, recognition and analysis of potential problems,
highly complex problem solving, resourcefulness and development of policies to prevent recurrence of problems.
* Strong communication and leadership skills; strategic thinker.

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