Associate Dir, Medical & Scientific Affairs

ANI Pharmaceuticals, Inc.; Princeton (NJ); Hybrid; USD 175,000 - 230,000; Full time

Job summary

ANI Pharmaceuticals, Inc. is seeking an Associate Director of Medical & Scientific Affairs to lead publication plans, medical communications, and material review across our rare disease portfolio.

You will collaborate with Clinical Operations, Regulatory, Legal, Compliance, and external experts to advance scientific exchange and evidence dissemination. The role requires strong scientific expertise, strategic thinking, and the ability to independently manage complex projects in a hybrid setup

Qualifications

• Advanced scientific/clinical degree required (PharmD, PhD, MD, or equivalent).
• Minimum of 5 years of relevant experience in Medical Affairs, Scientific Communications, Publication Planning, or related functions (rare disease experience strongly preferred).
• Strong understanding of regulatory/compliance in pharmaceutical industry, medical material review, and publication standards (GPP/ICMJE).
• Experience managing publication development and external agencies.

Responsibilities

• Support the development and management of publication and scientific communication plans across the rare disease portfolio.
• Develop scientific publications: peer‑reviewed manuscripts, abstracts, posters, oral presentations, plain language summaries.
• Coordinate with external investigators and publication agencies to support development, review, and submission per GPP/ICMJE.
• Lead the development of core scientific narratives, medical slide decks, and disease-state educational materials.
• Translate complex trial results and real-world data into accurate, balanced scientific communications.
• Represent Medical Affairs in regulatory review processes to ensure accuracy and substantiation.

Education

Advanced scientific/clinical degree

Job description

About Us

We are a publicly traded pharmaceuticals company committed to improving patient outcomes through

the development, manufacturing, and commercialization of innovative therapies.

Our Legal and Compliance team is a strategic partner to the business, supporting a dynamic portfolio of branded,

generic, and specialty pharmaceutical products. We foster a culture built on integrity, collaboration, and

a shared sense of purpose.

At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value

authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive

environment. Our culture empowers everyone to be successful and apply our full potential

Job Summary

The Associate Director, Medical & Scientific Affairs will play a key role in the development and execution of publication plans, medical and scientific communications, and medical material review activities across the rare disease portfolio. Working closely with Medical Affairs leadership, this role will be responsible for managing publication and scientific communication initiatives aligned with the broader Medical Affairs strategy, supporting the timely dissemination of clinical and scientific evidence, and ensuring the development of accurate, balanced, and compliant scientific content.

The Associate Director will collaborate with cross-functional stakeholders, including Clinical Operations, Regulatory, Legal, Compliance, and external scientific experts, to support scientific exchange and evidence dissemination across the product lifecycle. This role requires strong scientific expertise, strategic thinking, cross-functional collaboration, and the ability to independently manage complex projects and competing priorities in a dynamic rare disease environment. This is a hybrid position requiring three days per week in the office.

Position Responsibilities

• Support the development and manage the execution of publication and scientific communication plans aligned with Medical Affairs strategies and priorities across the rare disease portfolio.
• Manage the development of scientific publications, including peer-reviewed manuscripts, abstracts, posters, oral presentations, and plain language summaries, ensuring scientific accuracy, quality, and timely delivery.
• Collaborate with Medical Affairs leadership and cross-functional stakeholders to identify publication opportunities, evidence gaps, and scientific dissemination priorities.
• Coordinate with external investigators, authors, and publication agencies to support publication development, review, and submission in accordance with Good Publication Practice (GPP), ICMJE recommendations, and applicable company policies.
• Identify and recommend appropriate peer-reviewed journals, scientific congresses, and other channels for dissemination of clinical and scientific evidence.
• Manage the development of core scientific narratives, medical slide decks, disease-state educational materials, and other evidence-based scientific communication resources.
• Translate complex clinical trial results, real-world evidence, and emerging scientific data into accurate, balanced, and clear scientific communications for internal and external audiences.
• Coordinate scientific congress activities, including the development and review of abstracts, posters, presentations, and related scientific materials.
• Support the development and scientific review of materials for advisory boards, investigator meetings, and other Medical Affairs scientific engagement activities.
• Represent Medical Affairs in medical, legal, and regulatory review processes, providing scientific expertise to ensure the accuracy, balance, and appropriate substantiation of medical and promotional materials.
• Manage external publication and medical communication agencies, including project timelines, deliverables, and budgets, in alignment with established Medical Affairs priorities.
• Independently manage assigned publication and scientific communication initiatives, coordinating cross-functional stakeholders and ensuring timely delivery of high-quality scientific outputs.

Skills/Competencies

• Scientific and clinical expertise with the ability to interpret and communicate complex data.
• Strategic and analytical thinking.
• Cross-functional leadership and collaboration.
• Attention to detail and commitment to compliance.
• Strong project management skills.
• Ability to develop high-quality scientific content and deliver impactful medical information services.
• Demonstrated ability to synthesize complex scientific data into clear, concise, and balanced communications.
• Excellent written and verbal communication skills; strong interpersonal and collaboration abilities.
• Ability to thrive in a fast-paced, evolving rare disease environment with a high degree of autonomy and accountability.
• Demonstrated ability to exercise independent scientific judgment, manage competing priorities, and provide recommendations to Medical Affairs leadership.

Qualifications

• Advanced scientific/clinical degree required (PharmD, PhD, MD, or equivalent).
• Minimum of 5 years of relevant experience in Medical Affairs, Scientific Communications, Publication Planning, or related functions within the pharmaceutical or biotech industry (rare disease experience strongly preferred).
• Strong understanding of pharmaceutical industry regulatory and compliance requirements, medical material review processes, and scientific publication standards, including GPP and ICMJE recommendations.
• Demonstrated experience managing publication development, medical and scientific communication deliverables, cross-functional review processes, and external publication or medical communication agencies.
• Experience interpreting and communicating clinical trial results, real-world evidence, and other scientific data to healthcare and scientific audiences.

Salary

The base salary range for this position is $175,000-$230,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results.

Benefits

ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.

Remote

#Remote