Disclosure Specialist

South San Francisco, CA 94080 | Contract

Post Date: 06/18/2018 Job ID: 4391 Industry: Project Management

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

 
  1. Intact & Cross-Functional Teams
  • Participates in site and/or regional PD Disclosures departmental meetings
  • Operates within a global organization with flexibility for early meetings (1-2 times per week)
  • Represents Disclosures and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

 
  1. Disclosures
  • Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics
  • Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
  • As needed, provides Disclosures expertise to cross-functional teams and other groups
  • Contributes to development and maintenance of policies and/or Standard Operating Procedures (SOPs) on clinical trial registry and clinical trial results database processes
  • Identifies studies required for registry and results postings, including applicable trials for results postings on relevant external websites.  Ensures that responsible PDR management and staff are aware of timelines, deadlines and other requirements
  • Tracks missing/late registry entries and Clinical Study Reports (CSRs) and liaises with PDR teams regarding dates of new product or line extension approvals
  • Liaises with project teams and affiliates to ensure they understand their responsibilities in relation to regulatory documentation disclosures
  • Submits protocol documents for preparation of registry entry and for quality control checks, i.e., consistency between registry and protocol, cross-protocol and franchise consistency.  Similarly submits CSR document for preparation of results entries
  • Works with cross-functional team members to obtain data, reviews and approvals required for completion of registry and results entries on internal and external websites
  • Monitors workflows for registry and results entries to ensure timely and on-target completion
  • Completes document and data uploads in applicable systems
  • Ensures protocol information is included in the registry as soon as the study design is finalized and first ethical/regulatory approval is received
  • Ensures that study results are uploaded into results databases within applicable timeframes
  • Tracks correspondence with cross-functional teams and departments via departmental mailboxes and ensures appropriate responses are provided in a timely manner

 
  1. Other
  • Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Disclosures-specific systems, processes or other relevant tools  
  • Completes routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
  • Participates in other special projects, as and when assigned, or otherwise requested  
  • Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
  • Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines

 

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “ preferred,” or as a “ plus,” all points listed below are considered minimum requirements.

 

QUALIFICATIONS & EXPERIENCE:

  • Bachelors Degree preferred (life sciences disciplines strongly preferred)
  • Average of 3 or more years’ relevant experience in the pharmaceutical/biotechnology industry.  Some previous experience in regulatory affairs or other product development functions is preferred
  • Medical writing  and/or editing experience is preferred
  • Some understanding of international regulations, processes and issues in drug/biologics development is preferred. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
  • Some understanding of product and safety profiles
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Fluent English and other language skills as needed

 

ABILITIES:

  • Has impeccable ethics.
  • Outstanding attention-to-detail
  • Has working knowledge of the multidisciplinary functions involved in pharmaceutical/biotechnology product development, e.g. clinical development, clinical operations, biostatistics, commercial operations, etc.
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
  • Good interpersonal, verbal communication and influencing skills: can influence without authority
  • Strong written communication skills
  • Good business presentation skills: is comfortable and effective when presenting to others, internally or externally
  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
  • Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
  • Works well within teams and is effective in collaborating with others internally and externally
  • Ability to travel
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