Regulatory Manager

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com

What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?

We understand that you are looking for growth and variety in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We hire the best and trust them from day 1 to deliver global impact, handle teams and be responsible for the outcomes while our leaders support and mentor you.

We are a profitable rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.

If this excites you, then apply below.

Associate Manager / Manager – Regulatory Writing (Clinical)

EXPERIENCE: 10 to 12 years’ experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)

ROLE PURPOSE: This role is responsible for handling complex Medical Writing projects and provide review support for medical writing deliverables that support the clinical regulatory writing portfolio along with training the junior writers.

SKILLS:

• Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, ICFs & amendments, and Investigator Brochures (IBs) • Demonstrated excellence in focused/lean writing and editing following defined processes and templates

• Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions

• Understanding of clinical development process from program panning to submission, including clinical trial design

• Communication skills commensurate with a professional working environment

• Effective time management, organizational, and interpersonal skills

• People management experience for more than 2 years

• Customer focus

• Comfortable following directions, templates, and structured processes for delivering documents for review and finalization

• Able to work independently while maintaining communication with the Sponsor’s MW project manager

• Ability to move across Therapeutic Areas to support business continuity and resource needs

• Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines

• Develop work plan and ensure adherence

• Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion

• Adherence to processes and Sponsor-defined best practices

• Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements

KNOWLEDGE REQUIREMENT:

Scientific Knowledge

• Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States

• Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) • Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science

• Understanding of medical practices regarding procedures, medications, and treatment for different disease states

• Manage messaging for consistency with historical information and in alignment with agreed-upon strategy

• Capable of providing insight, alternatives, and suggestions based on previous experiences

• Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring

• Experience writing protocols, amendments, CSR, and CTD summary documents

Technology Skills

• Expert authoring in MS Word, understanding of MS Word functionality

• Experience working in document management systems; managing workflows eApproval/signatures • Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc.

• Flexibility in adapting to new tools and technology

• Capable of training writers/authors on the use of templates, guidelines, and tools

RESPONSIBILITIES:

• Without guidance from senior members of the writing staff, prepare/review clinical study reports