CMC Writer

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)

The CMC Technical Writer will be responsible for CMC technical document authoring and compiling CMC sections for global regulatory filings by working closely with the cross-functional teams to ensure all CMC technical writing objectives are met.

• • Manages the CMC regulatory writing strategy of high quality and compliant regulatory CMC documentation (e.g., INDs, CTAs, MAAs, CASs, NDAs Variations/Supplements and other relevant regulatory filings) for the assigned product(s) within defined timelines as per R&D and business objectives.
• Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.
• Responsible for determination of regulatory and scientific/technical requirements for CMC and GMP related submissions
• Work closely with the Technical Operations team to ensure alignment and established priorities to meet corporate goals.
• Work collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high quality level of cGMP produced documentation excellence.
• Strong understanding of drug development process, pharmaceutical technology, drug manufacturing processes, analytical and GMP.
• CMC regulatory requirement knowledge for small molecules development through post approval and annual updates.
• US, Europe, Japan and Canada submissions experience and knowledge of guidelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

* BS in Chemistry, Pharmaceutical sciences, Regulatory Affairs or other relevant field.

* 3-5 years of experience in authoring CMC sections of regulatory filings.

* Experience working closely with other departments such Process Chemistry, Analytical, PDMs, Reg. Ops and Regulatory Affairs.

* Demonstrate competency in clear and concise technical writing ability.

* Understand CMC manufacturing documentation requirements for small molecule manufactured products.

* Demonstrate track record of effective leadership including organization and prioritization of workload.

* Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.

* Good decision making with strong judgment through collaboration and consideration of others point-of-view.

* Sound technical knowledge of process chemistry, analytical methods, and drug product.

* Must be well organized, flexible and able to communicate effectively within CMC functions and Regulatory affairs.

* Must be knowledgeable and worked in biotech manufacturing related industry.

* Demonstrate excellent understanding of cGMP manufacturing execution.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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