Reference Safety Document Lead (Sr. Manager)

Remote, New York
July 29 2021
Position Type
Full Time
Organization Type
Job Type

This role collaborates across business units and functional lines to ensure that Investigator's Brochures (IBs) are created, revised, maintained, and submitted in compliance with governing SOPs and regulatory requirements. The RSD Lead is an extended study team member and is responsible for tracking and releasing Single Reference Safety Documents (SRSDs) to keep investigator's informed and for their specific use as the reference safety information (RSI) for expectedness assessments by drug safety analysts. The role will be accountable for contributing to relevant initiatives, including continuous improvement projects and technology advances to ensure effective management and delivery of all reference safety documents used in clinical trials. The role will report to the Reference Safety Document Management Head.


Provide overall management of the creation and maintenance of Investigator Brochures, by;
  • Chairing IB meetings, leading team discussions utilizing subject matter and regulation expertise to establish appropriate strategy for the IB.
  • Providing end-to-end project management of the IB deliverable, setting clear targets and ensuring all functional lines are aware of commitments, securing necessary contributions, and completing within agreed timelines.
  • Ensuring full execution of all IB documents (initial creation and updates) in compliance with ICH guidance, regulations and internal policies.
  • Interpreting and advising current regulations/guidance considering the wide range of needs of various internal stakeholders.
  • Identifying risks and leading IB contributing teams through issues and barriers to achieve timely and quality resolution.

Managing Single Reference Safety Documents (SRSDs) associated with clinical trials by;
  • Monitoring for updates to their Reference Safety Information (RSI)
  • Obtaining appropriate authorizations from key regulatory and safety contributors
  • Maintaining appropriate versions and make availability by drug safety teams, and
  • Communicating all updates to clinical investigators

Contribute to the broader needs of the Reference Safety Document Management team by;
  • Serving as a subject matter expert for products within their scope of remit
  • Understanding roles, responsibilities and dependencies of upstream and downstream stakeholders and deliverables.
  • Acting as a subject matter expert for quality events, contributing to the investigation/root cause analysis and remediation actions as appropriate.
  • Providing training and mentoring to new colleagues and any contractors/vendors involved in the process.
  • Proactively evaluating current systems and processes and offering suggestions for improvements.
  • Assessing external regulatory requirements, ICH guidance and performing initial impact assessment when requested.
  • Ensure all actions taken within role follow applicable policies, SOPs and associated documents so that high quality delivery of outputs and compliance is maintained.


"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact."
  • Bachelors Degree in Life sciences, Pharmacy, or equivalent with 9+ years of pharmaceutical regulatory or clinical experience, Masters with 7+ years OR PhD with 4+ years.

  • 'Hands on' pharmaceutical experience associated with content development and maintenance within the area of Regulatory Affairs, Drug Safety, or Medical Affairs
  • Understanding of the dynamics and purpose of a company Investigators Brochure and core function of SRSD management is highly desirable.
  • Knowledge of overall drug development process and experience with regulated deliverables.
  • Basic Pharmacovigilance knowledge desirable.
  • Proven ability to understand regulatory implications on strategy for product deliverables.
  • Knowledge of ICH, CIOMS and key markets regulations and requirements.

Technical Skills
  • Proven leadership in leading global teams through consistent execution and delivery.
  • Demonstrated ability to build and foster strong matrix team working relationships across global setting.
  • Strong project management skills with a focus on quality and compliance. Skilled in managing and delivering multiple projects on time despitecompeting priorities and conflicts.
  • Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Demonstrated ability to influence and negotiate despite having a wide and diverse set of stakeholders.
  • Ability to interpret and apply global and local regulatory requirements and guidance to business needs, in both pre and post approval products.
  • Proven ability to make sound decisions and seek to resolve problems in a proactive, independent manner.
  • Proven excellence in effective written and oral communication.
  • An understanding of medical terminology.

Other Job Details

Last Day to Apply: 8/27/2021

Eligible for Employee Referral Bonus

Additional Location Information: US Remote


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