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Project Manager
I softcorp Boston, MA
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$99k-127k (estimate)
Full Time Just Posted
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I softcorp is Hiring a Project Manager Near Boston, MA

Role: Project Manager
Location: Alexion: Seaport HQ, Boston, MA
Onsite: 3x a week
Contact length: Around 6 month
Local candidates only
This is what you will do:
Developing and implementing global and/or US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
You will be responsible for:
Developing and directing innovative and effective regulatory strategies in support of specific projects, and across projects in the Alexion portfolio.
Serving as global or US Strategy lead on assigned programs. Acting as submission sub-team lead for US submissions and is core member of Regulatory Subteam (RST) for assigned programs.
Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.
Representing Alexion as point contact FDA and leading Alexion delegation for regulatory authority meetings.
Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, new marketing authorisation applications, etc.
Monitoring the development of new regulatory requirements or guidance documents and advising product teams of the impact on the business or development programs. Providing support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
Ensuring exemplary behavior, ethics and transparency within the company and with regulatory agencies.
You will need to have:
Strong knowledge of US drug development and regulatory policy; excellent scientific and business judgment.
Experience providing US strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
Experience with leading major submissions and FDA meetings
Ability to manage complex issues and coordinate multiple projects simultaneously
Ability to build intra-team relationships and collaborate in a global team environment at all levels of the organization.
Strong interpersonal, and written/verbal communication skills.
Proven track record practicing sound judgment as it relates to risk assessment
Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and Google Cloud Platforms; solid understanding of where to seek and how to interpret regulatory information.
Bachelor s Degree in a related discipline
5-7 years experience

Job Summary

JOB TYPE

Full Time

SALARY

$99k-127k (estimate)

POST DATE

06/13/2024

EXPIRATION DATE

06/26/2024

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I softcorp
Full Time
$99k-127k (estimate)
Just Posted

The following is the career advancement route for Project Manager positions, which can be used as a reference in future career path planning. As a Project Manager, it can be promoted into senior positions as a Planner/Scheduler IV - Construction that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Project Manager. You can explore the career advancement for a Project Manager below and select your interested title to get hiring information.

GradBay
Full Time
$115k-145k (estimate)
Just Posted

If you are interested in becoming a Project Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Project Manager for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Project Manager job description and responsibilities

Managers ensure that the project team members are meeting the deadlines and following the guidelines.

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Project managers also give and take regular updates from team members and conduct status meeting etc.

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Therefore, a project manager must be flexible enough to work within a project’s plan but readily adapt when necessary.

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During this phase, project managers strive to ensure all activities necessary to achieve the final result are completed.

02/04/2022: Concord, NH

Days can be filled with planning the project process, creating a budget, managing a team or communicating with clients.

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Project Manager jobs

Leverage tools for project management.

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Learn from other high-performing project managers.

04/06/2022: Virginia Beach, VA

Set realistic, yet ambitious deliverables.

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Set Realistic Expectations to Avoid Project Delays.

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Be a Fearless Project Manager.

03/16/2022: Norwich, CT