Associate Director, Medical Writing

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

The Associate Director, Medical Writing will be responsible for driving the planning, development, and completion of regulatory documents, including but not limited to protocols, right-to-operate documents such as investigator’s brochures and annual reports, Investigational New Drug (IND) and New Drug Application (NDA) documents including integrated summary documents, submissions and regulatory response, and briefing documents to support Regulatory and Health Authority interactions. The ideal candidate possesses both scientific and communications expertise as well as the leadership skills needed to facilitate cross-functional team engagement in document development.

The candidate may also have responsibility for oversight of vendor partners.

Responsibilities:

· Plan, draft, edit, and review regulatory documents:

o Develop timelines for documents assigned

o Coordinate first-draft authoring of documents, whether with Subject Matter Expert (SME) input or independently

o Edit for consistency and clarity as well as for adherence to Kailera style guide requirements

o Ensure approval of content within specified timelines

· Ensure documents meet regulatory needs and guidelines as well as align with business strategies

· Demonstrate expertise in regulatory and clinical document requirements for major Global Regulatory Authorities, including the US, Europe, and Japan

· Formulate concise and clear key messages for relevant document audience

· Understand external environment for indications and therapeutic areas relevant to assigned projects

· Engage in industry and functional organizations as appropriate to ensure Kailera is utilizing current best practices

· Act as SME for Kailera authoring templates and systems (Sharepoint, MS Office Suite, Veeva Vault RIM, etc)

· Contribute to projects

Qualifications:

· Bachelor’s degree required

· Minimum of 5 years industry experience in regulatory medical writing, regulatory affairs, medical affairs, or other relevant professional experience

· Clear understanding of drug development, including phases, processes, and techniques used within clinical devel

· Demonstrated ability to effectively communicate both in written communications and through presentations and facilitation

· Ability to work both independently and as part of cross-functional team

· Proficiency with relevant software applications, including the MS Office suite (Word, Powerpoint, Excel); Veeva Systems; Sharepoint; and others as assigned

· Emotional intelligence – demonstrate the ability to manage through stressful situations ensuring a win-win approach

· Ability to create timelines and manage projects assigned

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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