Associate Program Manager

South San Francisco, CA 94080

Posted: 08/13/2019 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 6673

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.

Regulatory Labeling Associate Program Managers are responsible for providing strategic and operational leadership for labeling of pharmaceutical products and devices, including the generation and revision of global core data sheets (CDS), U.S. package inserts (USPI), and package labeling.

 

PRIMARY DUTIES AND RESPONSIBILITIES:

Cross-Functional Teams
  • Participates in site, regional and/or global departmental meetings
  • As appropriate, may participate as a standing or ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant, less complex products. When assigned, represents PDRL and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As needed, may advise as an ad hoc member in various teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

Regulatory Labeling 
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for therapeutic areas and products. 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 the company and regulatory guidelines, procedures and best practices
  • Supports development of the cross-functional regulatory strategy for each product or related assignment by providing regulatory labeling expertise, insights, perspective and recommendations
  • Participates in and supports the process for timely development, maintenance and revisions for product labeling for pharmaceutical products and devices, including:
    • Coordinating preparation of documentation package supporting proposed CDS or USPI changes
    • Communicating CDS changes to internal partners and stakeholders, including affiliates
    • Supporting the implementation of CDS changes into the local labels
    • Tracking local label-CDS compliance and recording reasons for difference
    • Collecting and archiving the supporting documentation package for initial development and subsequent updates of CDS/USPI in appropriate internal database systems
    • Supporting creation and maintenance of CDS templates
  • Supports or otherwise compiles background packages (competitor labels, relevant guidelines, etc.) for internal labeling working group discussions
  • May participate in ongoing RAFT meetings. Including providing ongoing expertise regarding regulatory labeling, guidance on compliance, timing and other relevant matters
  • As requested, provides support to Regulatory Labeling Program Directors pre-and post- cross-functional meetings, other interactions and communications, which may include support in generating meeting minutes, distributing information, conducting post-meeting follow-up, etc
  • Supports or otherwise provides competitive labeling comparisons to RAFT and other USPI teams, as required for CDS/USPI preparation, submission and completion
  • Works collaboratively with global labeling personnel at other sites to ensure sharing of best practices and to enhance quality and consistency of processes
  • Participates in and/or otherwise supports development and implementation of new or updated PDR and/or PDRL-specific Standard/Department Operating Procedures (SOPs/DOPs), systems, processes, or other relevant tools.  Includes efforts to build greater efficiency into the Promotional Review Committees (PRC) process

 

Other
  • May complete 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, SOPs and other guidelines


 

QUALIFICATIONS & EXPERIENCE:

  • Bachelors Degree required (life sciences disciplines strongly preferred)
  • Advanced Degree in related field is preferred
  • Average of 3 or more years’ work experience in the pharmaceutical, biotechnology or related industry.  Previous regulatory affairs experience, including labeling experience, is preferred
  • Demonstrated 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, FDA, EMEA, NICE and other relevant guidelines
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), Adobe Acrobat, relevant publishing and document management systems/software
  • Fluent English and other language skills as needed

 

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or has proven abilities to demonstrate, company Values & Leadership Competencies
  • 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 and 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 (<10%)
Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.