Job Description

Job Description

Reporting to the Regulatory CMC (Chemistry, Manufacturing, and Control) Principal Scientist, the Associate Principal Scientist is responsible for supporting the cross-modality design of CMC Business Processes. This role is responsible to support the design of CMC business processes that support change control execution, CMC dossier preparation, CMC Health Registration Management, and operational activities that will deliver accurate and compliant regulatory information in Regulatory and Change Control IT systems. The Associate Director will ensure CMC procedures to support business processes are developed, maintained and training completed, as required. This role interfaces with Global Regulatory Affairs and our company's Manufacturing Division to integrate CMC requirements into shared regulatory and change control systems and processes.

The role will define and communicate regulatory requirements and negotiate solutions for the redesign of our company's Change Control System and supporting business processes. This role will ensure there is visibility and consideration of regulatory needs in the design of the future state change control process and facilitate regulatory engagement to deliver appropriate interfaces to regulatory systems.

Regulatory CMC Responsibilities:

* Provide CMC input to the team accountable to redesign our company's Change Control System and supporting business processes, ensuring user community input is obtained and addressed in system/process design

* Identify and communicate gaps in our Manufacturing Division/GRACS CMC and Change Control system/process capabilities; Leverage knowledge and experience to constructively influence the design of compliant and efficient solutions

* Interface with the GRACS BPIM organization to communicate Change Control redesign plans and gain alignment with the GRACS IM strategy. This is a critical interface that will ensure regulatory information is provided to our Manufacturing Division tools without compromising the integrity of GRACS regulatory information

* Serve as a Change Agent to educate and guide the Change Control redesign project team and the CMC user community to an improved understanding of the current regulatory environment and the impact on legacy business processes, fostering a more strategic mindset and promoting regulatory conformance

* Develop and author CMC procedures to support business processes and conduct/facilitate training, as required

* Propose solutions that consider broad organizational interests and balance perspectives to achieve win-win solutions; proactively and constructively confront problems or conflict across teams, organizations, or divisions and influence resolution

* Highlight issues and negotiate solutions that align with business and compliance requirements and escalate to GRACS and our Manufacturing Division Senior Leadership, if needed

Technical Skills:

* Proven experience in CMC change control assessments and developing CMC submission documentation including the ability to critically review detailed change control information to assess technical merits, suitability of scientific rationale, and completeness to ensure information is presented clearly and conclusions are adequately supported by data.

* Thorough understanding of regulatory CMC processes, including change control, regulatory dossier maintenance, and regulatory information management.

* Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.

* Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem-solving.

Leadership Skills:

* Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

* Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.

* Demonstrated effective leadership, communication, interpersonal, and negotiating skills.

* Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.

Please note, relocation assistance is not provided for this position.

Minimum Education and Experience Required:

* B.S. in science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry

* At least five (5) years of pharmaceutical industry experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields with at least 3 years of CMC experience

* The candidate must be proficient in English; additional language skills are a plus

GRACSERP

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R89499