The Company  

Our client, ImprovementatWork Inc (IaW), is an owner-managed, US and Europe based boutique consulting firm. They assist companies in the Pharma and Biopharma industry in their first product submission process to obtain market approval. US operations are guided from Cambridge, MA and EU operations from Antwerp, Belgium.

IAW is an equal opportunity employer that is committed to diversity & inclusion in the workplace.

For IAW’s operations and due to business growth in the United States we are looking to fill a (Sr) Director Submission Process position.
This role will be operating as external consultant to their 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. In this position you will act as the main project leader for the submission while optimizing internal processes and coaching client employees and managers to deliver and 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, driving consensus and reaching deadlines are crucial success factors. In addition, you will build and maintain your network, search for business development opportunities and approach decision makers to explain your expertise and added value.

This position reports directly to the President of IaW .

 Responsibilities  

• 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 development 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 as well as client vendors/partners to ensure awareness of plans, milestones 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 lessons learned. Leverage learnings by training and communication within the company.
• Ensure effective communication throughout the organization.
• Build and expand your network of regulatory experts and industry leadership.
• Be open, involved, and active to attract business opportunities and potential new clients.

We are looking for candidates with:

• 5 to 8 years of pharmaceutical/biotechnology industry experience; Scientific or related master’s degree preferred
• Knowledge of late stage drug development is a must (data management, regulatory, regulatory operations, CMC, statistics or clinical development).
• Direct submission experience (initial NDA/MAA is preferable) and a leading role in a submission team.
• Proven project management skills and experience.
• The ability to work independently, effectively handling conflicting priorities in a changing cross-departmental and international environment.
• Self-motivated and self-starting characteristics. A proven track record showing the ability to work effectively and conscientiously when under tight schedules and with 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 discretion when needed. Ability to lead complex discussions at all levels of the organization.
• Passion for hands-on work and who consistently ensures high quality results through attention to detail.
• 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 challenge the status quo.
• The drive to be accurate, independent, and willing to challenge existing, client process or way of working.
• Communicating to clients and colleagues, 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.
• Ability to influence without direct or assigned authority.
• The willingness to work on-site, when requested, and simultaneously be able to guide and facilitate client teams by remote management while working from home.
• Experience with technology and (IT)tools. Experience in managing complex projects; operational knowledge of MS Office/Outlook, MS Visio/Concept Draw, Office Timeline, Smartsheet, MS Project or similar.

We are seeking a dynamic, ambitious, results-oriented, down-to-earth, leader with strong commitment as well as the willingness to assume a high degree of responsibility. Although you are not directly managing staff you are “Leading and Achieving results through Others”.
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 apply analytical/systematic thinking.

 Application Process

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 IAW.
A psychometric assessment can be part of the recruitment process.

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.

Contact information: 

For more information about this opportunity please contact Mr. Loek (Luke) Vandebroek, by phone at (617)-401-2259.

You may apply for this position by sending your relevant application documents (cover letter and detailed CV) via e-mail to loek.vandebroek@marwilhr.com

Improvementatwork Inc  is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.