Job Description

Title: CMC Analyst – QA

Location: Remote: Located anywhere on EST time zone

Duration: 8-month Contract (with extension up to 3 years)

Responsibilities:

Provide regulatory CMC leadership on the cross functional sub teams (regulatory science project teams, asset teams) and advises on best practices and/or supports PDCs.

Responsible for managing global regulatory CMC line reports (if applicable) and providing input to Global RegCMC initiatives and cross functional work streams as assigned by the Global CMC Team

Leads or provides input to Global CMC initiatives and cross functional work streams as assigned by Global CMC LT.

Participates in skill development and coaching of other Global CMC Team members as required.

Qualifications:

This candidate must have proven leadership and abilities to work cross-functionally and across cultures. 

Strong communication, regulatory CMC knowledge and interpersonal skills are required.

At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 5+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.

Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities

Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure

Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.

Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.

Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.

Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.

Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business prioritie

For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

JO-2405-146393

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