26 Sep Senior Director Submission Process
Director Submission Process
Our client, ImprovementatWork, is an owner-managed, US and Europe based boutique consulting firm, which accompanies and leads the new product submission process to obtain market release 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. As employer, ImprovementatWork strongly believes in diversity and equal opportunity.
For ImprovementatWork’s operations in the United States we are looking for a Director Submission Process who operates as external senior consultant to our customers predominantly in the greater Boston area.
The Position Overview
The role is intended to work with little supervision and run client projects with client teams as their main project leader for product submission while optimizing internal processes and coaching client employees and managers to deliver what is expected and support all involved to be successful.
This position focuses on the submission process itself and not on the content which is the responsibility of client subject matter experts. Moving things forward and reaching deadlines are crucial success factors.
The reason we are hiring for this position is to allow taking on more projects and assignments while sustaining the current high level of expertise, quality and success. The position reports directly to the Managing Director/Co-Owner of ImprovementatWork Inc.
- Translate regulatory strategy for NDA/MAA (and other) submissions into operational assumptions
- Implement strict planning to facilitate timely and high quality execution of all submission activities; works in close collaboration with regulatory teams and project management
- Lead continuous, permanent process improvement and institutionalization of processes for planning and creation 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 optimizations.
- 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. Leverages learnings by training and communication within the company.
- Ensure effective communication throughout the organization
We are looking for candidates with:
- A scientific or engineering master’s degree.
- Deep knowledge of drug development is a must (ideally data management, statistics, clinical (phase III) development).
- Direct submission experience (initial NDA/MAA) and a 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.
- Self-motivating and self-starting characteristics. A proven track record showing the ability to work effectively and conscientious when under tight schedules and under minimal direct supervision
- Proven ability and experience in effectively bridging gaps between the various stakeholders and bringing their ideas and processes together
- 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
- Clear and direct communication style while having strong organization sensitivity and understanding of culture yet not being intimidated by hierarchy or internal politics. Proven ability to speak up and use straight talk even if clients are not expecting or open to hear this.
- 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 willingness and drive to operate there where the action is, right at the work floor.
- 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.
- The willingness to work over 90% on-site at our client’s premises in the Greater Boston Area.
- 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.
- Excellent verbal and written communication skills utilizing high level business English.
We are addressing a dynamic, ambitious, results-oriented, down-to-earth, cost-conscious leader with strong commitment as well as the willingness to assume a high degree of responsibility. The leadership style we are looking for can be described as “bridging leadership” and its skills include: Listening & empathy, ability to connect diverse stakeholders, create a secure environment and analytical/systems thinking.
If this opportunity is in line with your profile as well as your career trajectory, we would urge you to apply. When applying for this role, please describe how you meet the characteristics, experience and competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application
Following your application, we will advise you on the viability of your candidacy. Should you enter into the formal interview process you will have the opportunity, through interviews with a variety of key stakeholders, to develop your understanding of the role and ImprovementatWork.
We hope you can understand that, if your profile is not appropriate for this particular role, we cannot guarantee we will be able to provide timely feedback on every occasion.
For more information about this opportunity please contact Mr. Loek (Luke) Vandebroek by phone at +31 6 53487564.
You may apply for this position by sending your relevant application documents (cover letter and detailed CV) via e-mail to email@example.com
ImprovementatWork Inc is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies:
ImprovementatWork Inc has engaged Next Step Talent Group exclusively to fill this position. ImprovementatWork Inc does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site or other sites where this position will be visible. All employment businesses/agencies are required to contact Next Step Talent Group to obtain prior written authorization before referring any candidates to Next Step Talent Group. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Next Step Talent Group (NSTG) and/or ImprovementatWork Inc (IAW). In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of NSTG and IAW. NSTG/IAW shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site or any other site where this position is posted.