Kelly Services is currently seeking a Regulatory Affairs CMC Project Manager I - Regulatory Project Manager Lead in Lexington, MA to work a contract assignment of 12 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.
Primary Responsibilities of the Regulatory Affairs CMC Project Manager I - Regulatory Project Manager Lead includes:
- Manages multiple multi-product CMC focus global submission to ensure timely completion per established timelines.
- In consideration of health authority requests & program plans, create project plans with documentation requirements, timelines, and identified and monitor activities of key deliverables.
- Will work closely with project leads, but require the ability to work independently with minimal supervision.
- Requires excellent verbal and written communication skills, must be able to manage concurrent projects that may be unplanned, detailed oriented, and organized.
- May require internal and external interactions in support of project plans.
- Proficient in MS Office and experience in databases and electronic system is highly desirable.
- Potential for Exposure to Bloodborne Pathogens/Infectious Materials
- The Regulatory Affairs Project Manager works collaboratively with the Regulatory CMC Strategists and cross functional project teams to ensure global regulatory strategies are developed and seamlessly executed upon enabling successful filings with Health Authorities.
- The RPM utilizes robust project management methodologies and ensures the development, utilization and continuous improvement of tools and processes to meet project deliverables
- 25 %: Partner with Regulatory CMC Strategists to provide leadership to global regulatory teams and cross functional sub teams to ensure global product regulatory filing strategies are developed, planned and flawlessly executed to meet all time, quality and regulatory requirements to support global product approvals and product life cycle management.
- 15%: Ensure global product specific regulatory strategies are documented, maintained, updated and proactively communicated with key stakeholders including obtaining all necessary buy-in by functional departments. Drive the development and implementation of integrated global regulatory strategies for investigational and marketed products.
- 15%: Lead and facilitate product specific regulatory meetings and functional sub teams meeting to oversee, plan and deliver regulatory filings, responses to regulatory queries, and preparation of regulatory meeting materials. Clearly communicate decisions and action items to team members and relevant parties outside of the team.
- 20%: Prepare meeting schedules, agendas, minutes, action item listings and timelines for global regulatory meetings and filings. Actively manage filing timelines including a clear understanding and communication of inter dependencies and critical path items. Maintain action item tracker logs and project timelines to ensure complete alignment of tasks which will focus contributors to achieve regulatory milestones. Prepare and distribute reports and trackers to communicate updates and project status.
- 5%: Collaborate with the Regulatory Submissions Group to plan documentation requirements and negotiate on publishing support timelines to ensure resources are allocated and available to meet submission timelines.
- 5%: Proactively communicate regulatory programs and submission statuses including key decisions to stakeholders. Proactively and creatively problem solve and generate options to enable effective and timely decision making. Identify and elevate potential major and critical risks / issues to management in a timely manner and ensure robust mitigation plans are prepared. Utilize skillful negotiating conflict resolution techniques
- 5%: Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables. Monitor team dynamics regularly to ensure optimal team performance, taking action to correct problems within a team stemming from miscommunication, differences of opinion, misaligned objectives, inexperience, etc.
- 5%: Track Project variances and report and prepare variance reports. Identify root causes of variances. Conduct lessons learned sessions to identify areas for improvement and maintain tracker for implementation of short and longer term corrective and improvement measures into standard regulatory project management practices. Develop, implement and continuously improve upon the PM tools and processes for the worldwide regulatory project management of new product licensures and life cycle project management for existing products.
- 5%: Provide effective Project Management services as needed to Regulatory Affairs Department for non product related initiatives to support business needs of organization
Key Skills, Abilities, and Competencies
- Ability to work effectively in matrix organizational structures
- Effective at motivating and energizing others, establishing clear goals, delegating responsibility
- Well developed and effective team facilitation and leadership skills; able to establish cooperative team environments with internal team and with external partners
- Superb oral and written communication skills
- Team player with demonstrated ability to work in a fast paced environment
- Strong negotiation, planning and organization skills
Complexity and Problem Solving
- Works on complex problems in which analysis of information requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Education and Experience Requirement of the Regulatory Affairs CMC Project Manager I - Regulatory Project Manager Lead includes:
- Bachelor’s degree in a scientific discipline ( coursework in Chemistry, Biology, Biochemistry, and/or Pharmacy, etc) and at least one year of regulatory related course work is preferred.
- Experienced with PM tools
- PMP Certification or equivalent highly desired
- At least 5+ years working experience in Project Management leading cross-functional drug development, supply chain or regulatory teams
- Contract assignment, duration 12 months.
- Work schedule: full-time, first shift. (8:00AM-5:00PM)
Kelly Temporary Employee Perks:
- Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase—and the coverage is portable*
- Service bonus plan and Holiday pay plan, if qualified
- Weekly electronic pay options
- Free online training campus available
- Exclusive online employee community
- Corporate discounts
This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:
Sandy at: Sanm174@KellyServices.com
Thank you for your interest in the assignment.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.