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Associate Director, Contracts and Outsourcing, Business Operations

Hybrid; Cambridge, MA

Posted: 04/18/2022 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 3191

Job Description

Our client  is seeking an experienced, agile, and highly motivated individual to manage contracting and outsourcing activities for our global Pharmacovigilance and Medical Affairs organizations.  The successful candidate will be detail-oriented with a customer-focused approach and the ability to effectively communicate and collaborate with internal and external stakeholders.

Reporting to the Director of Clinical Outsourcing, this role will be responsible for coordinating the selection and contracting of vendors and consultants engaged to deliver services for both pre and post-marketing activities.   The successful candidate will have strong experience in outsourcing and contracts management with specific knowledge of Pharmacovigilance and Medical Affairs functional area activities.

The ability to effectively coordinate and organize in a fast-paced and results-oriented environment is a must. Applicants should be outstanding team members with a strong desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.


  • Provide primary outsourcing and contracting support to Pharmacovigilance and Medical Affairs organizations

  • Responsible for the administration of processes governing the coordination of contracts from the identification of need through vendor/consultant assessment and selection, negotiation, execution, analysis, and reporting.

  • Manage outsourcing strategies and ensure cross-functional alignment, implementation, and financial compliance.

  • Manage the bidding and vendor selection process and drafting/review of contract documents for outsourced services, optimizing appropriate tools and guidance documents to support the functional teams.

  • Analyze and negotiate budget and contract terms as needed, utilizing benchmarking tools and established negotiation parameters where appropriate.

  • Work closely with Legal, Procurement, Finance, Quality and other departments as appropriate to ensure that outsourcing and contracting needs are met and handled in a manner that is consistent with company requirements, applicable regulations, and good business practices.

  • Support strategic initiatives and development/updating of processes, tools, and templates to improve overall outsourcing and contracting practices.

  • Review metrics related to the contract process and take appropriate action to improve efficiency and timeliness of contract processing.

  • Develop and maintain key relationships across a broad sphere of influence, both internally and externally, to ensure organizational goals are met.

Requirements / Qualifications:

  • Minimum of a BA/BS is required in a scientific, business, or legal discipline, or related field, with at least 8 years of experience in the pharmaceutical, life sciences or related industry, preferably in Pharmacovigilance, Clinical Development, and/or Medical Affairs or related function supporting those areas.

  • At least 6 years of experience in outsourcing and/or contract negotiation and management. Must have experience supporting Pharmacovigilance and/or Medical Affairs outsourced activities. Experience with support of Regulatory and Clinical Development activities also beneficial.

  • Thorough understanding of the drug development lifecycle including clinical development and post-approval commitments and applicable regulatory and legal requirements.

  • Excellent leadership and influencing skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe.

  • Track record of establishing effective business relationships with internal and external customers, demonstrating strong collaboration skills, commitment to relationship building, and a relentless focus in delivering on commitments.

  • Flexibility to adapt to the dynamic needs of a rapidly growing biotech company.

  • Exceptional negotiation skills— you are a tenacious problem-solver with a focus on building mutually beneficial relationships.

  • Curiosity that allows you to constantly learn and challenge the status quo, with a demonstrated commitment to process improvement and best practices.

  • Respect for others and a desire to work as a team.

  • Excellent written and verbal communication skills.

  • Strong organizational, analytical and prioritization skills for the management of multiple concurrent projects with strong attention to detail.

  • Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint).

  • A ‘ digital first’ mindset, creative in using IT solutions to drive efficiency wherever possible.
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