(Sr)Director Submission Process – First Product submission consultancy BioPharma

Greater Boston Area

Our client, ImprovementatWork Inc (IAW), is an owner-managed, US and Europe based boutique consulting firm, which assists companies in the Pharma and Biopharma industry in their first product submission process to obtain market approval. US operations are facilitated 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 the position of (Senior) Director Submission Process  who work as an external senior consultant to our customers predominantly in the greater Boston area.

The Position Overview 

In the role, you are intended to work with little supervision and run client projects with client teams. You will act as the main project leader for the submission, while optimizing internal processes and coaching clients, employees and managers to deliver succesful work. This position focuses on the submission process of the product 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.

The position reports directly to the Managing Director/Owner of IAW .

Responsibilities 

  • Translate regulatory strategy for NDA/MAA (and other) submissions into operational assumptions.
  • Implement strict planning to facilitate a timely and high-quality execution of all submission activities; work in close collaboration with regulatory teams and project management.
  • Lead continuous 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 clients, vendors and 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 these major capability or operational gaps.
  • Support and guide development teams in finding solutions and implementing improvements in processes and performance, share practices and lessons learned. Leverage learning by training and communicating 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:

  • A scientific or engineering master’s degree.
  • Knowledge of drug development is a must (ideally data management, CMC, statistics, clinical (phase III) development).
  • Direct submission experience (initial NDA/MAA is preferable) and a leading role in a submission team.
  • Proven project/program management experience.
  • The ability to work independently and to effectively handle conflicting priorities in a changing cross-departmental and international environment.
  • Self-motivated and self-governing personality. 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. Go where the action is on every level.
  • 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.
  • Clear and direct communication style while remaining 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 the 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.
  • Ability to influence without direct or assigned authority.
  • The willingness to work primarily on-site, or when requested, at our client’s premises in the Greater Boston Area, and simultaneously be able to guide and facilitate client teams by remote management while working from home.
  • 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 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 to develop your understanding of the role and IAW through interviews with a variety of key stakeholders,.
A psychometric assessment will 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, Next Step Talent Group, 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@nextsteptalentgroup.com

Improvementatwork Inc  is an Equal Opportunity 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.

Important notice to Employment businesses/ Agencies:

Improvementatwork Inc has engaged Next Step Talent Group exclusively to fill these positions.

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.

 

Solliciteer

Solliciteer
Maximale uploadgrootte: 33.55MB
Privacy