Manager-Scientific Writing (DDH Regulatory) GSC

Job Description

Primary Responsibilities:u00A0 This job description is intended to provide a general overview of the job requirements at the time it was prepared.u00A0 The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.u00A0 Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

• Responsible/accountable for management/delivery of overall book of work for assigned area (DDH Regulatory)
• Develops and executes sourcing plans in partnership with GSC leads to ensure seamless delivery of asset plan and priorities.
• Collaborates with function, capability, and site leadership to ensure alignment of business planning and operations.
• Coordinates across and develops synergies with therapeutic areas, phases of development, and geographies.
• Adjusts work plan based on shifting priorities using effective change control.
• Leads and directs internal and external team members in achieving team goals.
• Identifies and resolves issues impacting delivery of work.
• Conceives and implements new and efficient ways to accomplish goals.
• Partners in the selection process and may manage relationship for preferred vendors.
• Regularly reports results of team activities/metrics to leadership and stakeholders
• Manage audit readiness, quality, and compliance to ensure deliverables are accurate, transparent, of high quality, and in compliance with internal/external guidance/regulation.

• Recruits, develops, and retains a strategic and operationally capable workforce skilled and knowledgeable in scientific communications.
• Effectively creates and manages an agile organization that continuously meets the needs of a changing portfolio.
• Builds an organizational culture aligned with Team Lilly u2013 inclusion, innovation, acceleration, delivery, integrity, excellence, and respect for people.
• Develops staff who demonstrate expertise in drug development, therapeutic area science, strategic thinking, project management, and cross-functional leadership.
• Provide input on employee development, talent assessment, and succession planning activities.
• Develops an organizational talent base that demonstrates judgment-based decision making.
• Provides guidance, training, and supervision to personnel.
• Appropriately manage the workload of direct reports monitor project timelines and quality, and communicate priorities to direct reports.
• Provide technical support and guidance to direct reports as needed.
• Evaluates performance by reviewing documents and attending writing team meetings, and recommends developmental actions for all assigned staff.
• Ensure all direct reports are compliant with company policies, procedures and regulations.

• Develop scientific content for deliverables as needed per the responsibilities covered in the job description for Scientific Communications Associate the percentage contribution of these responsibilities will vary according to the need of the business.

• Leads development of new and emerging capabilities to support the effectiveness of GSC.
• Functions as expert on document strategy, planning and execution, and industry standards and guidelines.
• Shares expertise with others.
• In partnership with others, develop, implement, and update Lilly policies, procedures, training, and tools that are compliant with industry guidelines.

Minimum Qualification Requirements:

• Masteru2019s degree in a scientific, health, communications, technology, health outcomes, or public health related field.
• 6-8 years of experience medical communication / pharmaceutical industry.
• 2-3 years of experience in leading/managing a key part of portfolio or business process.
• 2-3 years of Experience leading others, including relationship and team building, setting expectations, holding others accountable, and technical coaching.
• Strong scientific communication skills, including extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically.
• Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills.
• Successful completion of writing exercise.

Other Information/Additional Preferences:

• Advanced degree (MBBS, MD, PharmD, PhD, MPH).
• Educational/work background in a health care, medical affairs, clinical development, health outcomes, public health, scientific or medical communications field.
• Expertise in industry standards and best practices, compliance issues, and regulatory requirements.
• Strong leadership, problem-solving skills, negotiation/influence/motivation, project management and critical thinking skills with ability to use effectively in a team, cross-functional setting and/or global environment.
• Clinical pharmacology, therapeutic area or other medical/scientific-specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, endocrine, health outcomes, public health).
• Experience managing business plans, budgeting and capacity resourcing.
• Knowledge of scientific, statistical, and research principles and guidelines.
• Experience in the global environment and an appreciation for global diversity.
• Knowledge of software/tools used in scientific writing.
• Experience leading submission or launch activities.
• Limited travel, including international, up to 10%.

Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillyu00A0does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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