Director of Submissions (Clinical Research)
Our client is an owner-managed, US and Europe based boutique consulting firm, which accompanies and leads the new product submission process to obtain drug approval for a variety of customers in the Pharma and Biopharma marketplace. US operations are guided from Boston, MA and European operations from Antwerp, Belgium. Our client is an employer who strongly believes in diversity and equal opportunity.
Operations in the United States is looking to hire a Director of Submission Process who operates as external senior consultant to our customers predominantly in
the greater Boston area. Purpose of this new position is to allow taking on more projects and assignments without jeopardizing the current high level of expertise, quality and success.
The role is intended to work with little supervision and run client projects working closely with client teams for product submission while optimizing internal processes and coaching client’s employees and managers. This position focuses on the submission process itself and not on the content.
The position reports directly to the Managing Director/Co-Owner
$100,000 - 120,000 per year (Commensurate with experience) plus bonus and benefits
Facilitate timely and high quality execution of all submission activities working in close collaboration with regulatory teams and project management
Translate regulatory strategy for initial NDA/MAA (and other) submissions into operational assumptions.
Be in charge of continuous, permanent process improvement and institutionalization of processes for creation and planning of global common technical documents (CTD).
Drive readiness and execution of identified regulatory submissions within the organization.
Work with stakeholders at all levels in the organization to ensure awareness of plans, milestones, challenges and risks.
Work with line managers in the client organization to solve gaps in existing departmental and cross-departmental processes and organizational structures as it pertains to submission readiness and optimisations.
Determine capability and operating gaps across the organization as it pertains to submission readiness and submission optimization.
Drive remediation of major capability or operational gaps.
Support and guide development teams in finding solutions and implementing improvements in processes and performance, sharing practices and learning about the projects. Leverage learnings by training and communication within the company.
Ensure effective communication throughout the organization.
Does your skillset and work history match with the following criteria? If so, please use the apply online link on this page to complete the application to be contacted by one of our associates about this role. If you do not meet the minimum criteria, please do not apply for this position as only those candidates that meet all of the requirements will be considered.
A scientific or engineering master degree.
Deep knowledge of drug development is a must (ideally data management, statistics, clinical (phase III) development, CMC or regulatory).
Direct submission experience (initial NDA/MAA) and leading role in a submission team.
Proven project/program management experience.
The ability to work independently; handling effectively conflicting priorities in a changing cross-departmental and international environment.
The willingness and drive to operate there where the action is, right at the work floor.
Clear and direct communication style while having strong organization sensitivity and understanding of culture yet not being intimidated by hierarchy or internal politics.
Effective communication skills at all functional levels: involvement, active listening and discreet when needed. Ability to lead complex discussions at all levels of the organization.
Experience with technology and (IT)tools used to manage complex projects; operational knowledge of MS Office/Outlook, MS Visio/Concept Draw, MS Project or similar.
Self-motivating and self-starting characteristics.
The drive to be accurate, independent and willing to challenge existing, client process or way of working and communicating, without being complacent or opinionated.
The need to be pro-active and result driven while showing the ability to take the next step.
Proven analytical skills and willingness to apply systematic problem identification and resolution skills and/or tools.
A proven track record showing the ability to work effectively and conscientious when under tight schedules and under minimal direct supervision.
The willingness to work over 90% on-site at our client’s premises in the Greater Boston Area.
Excellent verbal and written communication skills utilizing high level business English.
CRO, CMO, cGMP, Pharmaceuticals, Biotechnology, Large Molecule, Small Molecule, Early Phase, Late Phase, Quality Control, QC, Manufacturing, Cerca, Cerca Talent, Cerca Life Sciences, Life Science, Research, Clinical Research, GMP, SOP, IND, CMC
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