Procedural Document Writer - Global Pharma or Biotech

BIP US; New York (NY); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Discretionary performance bonus

Matching 401k

PTO 20 days + 7 sick days

Job summary

BIP US seeks a seasoned Process & Procedures Lead to strengthen procedural documentation for a global Life Sciences client. You will design, map, and author SOPs/WIs, coordinating SMEs and business leaders to ensure compliant, inspection-ready processes.

This role emphasizes cross-functional alignment, project management, and lean writing, with a hybrid/remote work environment and a competitive base salary in the US Life Sciences sector.

Qualifications

• 5-10+ years in an external client-facing role as a Consultant or similar.
• 3-5 years documenting and updating business processes and procedures (SOPs/WIs) in Global Pharma/Biotech.
• Experience with Document Management systems, ideally Veeva.
• Awareness of GxP regulatory requirements.
• Industry/consulting experience in Global Pharma/Biotech.

Responsibilities

• Assess impact of procedural updates on current processes.
• Identify and engage SMEs, stakeholders, and leaders for content development and approval.
• Lead process mapping sessions; capture scope, inputs, outputs, and steps.
• Facilitate discussions to align scope and drive consensus on updates.
• Translate cross-functional activities into procedural docs and maps.
• Author procedural documentation aligning with content standards.
• Maintain project schedules; identify risks and escalate with recommendations.
• Address gaps related to deviations, inspections, and CAPAs.

Skills

Leadership

Process mapping

Project management

Communication

Cross-functional collaboration

Education

Bachelor’s degree in engineering or business

MBA preferred

Tools

Veeva

Job description

Business Integration Partners (BIP) is Europe’s fastest growing digital consulting company and are on track to reach the Top 20 by 2030, with an expanding global footprint in the US (New York, Philadelphia, Boston, Charlotte, Chicago, Houston). Operating at the intersection of business and technology we design, develop, and deliver sustainable solutions at pace and scale creating greater value for our customers, employees, shareholders, and society.

BIP specializes in high-impact consulting services across multiple industries with 6,000 employees worldwide. Our industry domains include Life Sciences, Financial Services, Energy, and Retail, supplemented with Data & AI, Cybersecurity, Risk & Compliance, Change Management and Digital Transformation practices. We integrate deep industry expertise with business, technology, and quantitative disciplines to deliver high-impact results for our clients.

BIP is currently expanding its footprint in the United States, focusing on growing its Life Sciences business within global pharmaceuticals and biotechnology. Our teams operate at the intersection of business strategy, technology, and data to help our clients in driving smarter decisions, reducing risks, and staying ahead in a fast-evolving market environment.

Specific Opportunity

We are seeking a seasoned Process & Procedures Lead to support a global Life Sciences client in strengthening its procedural framework amid rapid international growth and evolving regulatory demands. This role sits at the intersection of compliance, operational excellence, and stakeholder engagement.

The Consultant will lead strategic conversations with SMEs and business leaders across global functions to assess, design, and optimize procedural documentation (i.e., SOPs/WIs). This is a high-impact role requiring cross-functional collaboration, the ability to translate complex business processes into clear, compliant documentation that supports both operational efficiency and inspection readiness.

The consultant will manage and lead projects for the development of procedural documents for global development by:

• Assessing the impact of procedural updates or changes on the existing process and procedural landscape.
• Identifying and engaging SMEs, Stakeholders and Business Leaders required for content development, review, and approval to ensure cross-functional alignment and compliance.
• Leading process mapping sessions, capturing key process elements including scope, boundaries, inputs, outputs, steps, sequences, and visual representations.
• Facilitating process discussions to align scope, obtain perspectives, resolve discrepancies, and drive consensus on procedural updates, process improvements and content standards.
• Translating cross-functional activities into procedural documentation and process maps.
• Authoring of procedural documentation in a clear, concise, and compliant manner that aligns to internal content standards.
• Maintaining project schedules, proactively identifying risks or issues, and escalating with recommendations as needed to ensure timely delivery.
• Addressing procedural gaps related to deviations, inspection commitments, and CAPAs to ensure compliance and on time project completion.
• Collaborating with Quality Managers to ensure content aligns with internal Content Standards and Lean Writing Principles.
• Managing document workflows within the Document Management System, including review and approval cycles.
• Coordinating document approvals with business stakeholders and SMEs to ensure timely and compliant finalization.

Requirements

• Minimum 5-10 years in an external client facing role as a Consultant or other relevant experience.
• 3-5 years of experience in documenting and updating business processes and procedures, with a strong focus on authoring procedural documentation (i.e., SOPs, WIs), within the Global Pharma or Biotech industry.
• Document Management system experience, ideally in Veeva.
• Awareness of GxP regulatory requirements.
• Industry and/or consulting experience in Global Pharma or Biotech.
• Ability to understand and discuss complex information with people of diverse occupational backgrounds.
• Experience in controlled procedural document principles, process design and leading process improvements.
• Ability to understand and translate complex processes into lean processes.
• Strong leadership, organizational, and project management skills.
• Bachelor’s degree in engineering, business, or a related field. An MBA or advanced degree is preferred.

The base salary range for this role is $110,000 - $160,000.

• Choice of medical, dental, vision insurance.
• Voluntary benefits.
• Short- and long-term disability.
• HSA and FSAs.
• Matching 401k.
• Discretionary performance bonus.
• Employee referral bonus.
• Employee assistance program.
• 11 public holidays.
• 20 days PTO.
• 7 Sick Days.
• PTO buy and sell program.
• Paid parental leave.
• Remote/hybrid work environment support.

For more information about BIP US, visit https://www.bip-group.com/en-us/.

It is BIP US Consulting policy to provide equal employment opportunities to all individuals based on job-related qualifications and ability to perform a job, without regard to age, gender, gender identity, sexual orientation, race, color, religion, creed, national origin, disability, genetic information, veteran status, citizenship, or marital status, and to maintain a non-discriminatory environment free from intimidation, harassment or bias based upon these grounds.

BIP US provides a reasonable range of compensation for our roles. Actual compensation is influenced by a wide array of factors including but not limited to skill set, education, level of experience, and knowledge.